RegulationBreakthrough Therapy (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan), Orphan Drug (South Korea), Orphan Drug (United Kingdom)

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Sequence Code 9923006L

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Clinical Trials associated with Inotuzumab Ozogamicin

NCT06917911

/ Not yet recruitingPhase 2IIT

Phase II Study of Cytarabine + Daunorubicin (7 + 3) + Gemtuzumab Ozogamicin vs. Cytarabine + Daunorubicin (7 + 3) + Venetoclax for the Treatment of Newly Diagnosed Core Binding Factor Acute Myeloid Leukemia (CBF-AML) in Younger Adults: A MyeloMATCH Substudy

This phase II MyeloMATCH treatment trial compares the effect of venetoclax to gemtuzumab ozogamicin, when given with cytarabine and daunorubicin ("7+3" regimen), for the treatment of patients with core binding factor acute myeloid leukemia (CBF-AML). Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Gemtuzumab ozogamicin is a monoclonal antibody, called gemtuzumab, linked to an antitumor antibiotic drug, called ozogamicin. Gemtuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD33 receptors, and delivers ozogamicin to kill them. Chemotherapy drugs, such as cytarabine and daunorubicin work in different ways to stop the growth of cancer cells either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax with cytarabine and daunorubicin may have fewer side effects and be as effective or better than the combination with gemtuzumab ozogamicin in treating patients with core binding factor AML.

Start Date20 Nov 2025

Sponsor / Collaborator

National Cancer Institute

NCT06863259

/ RecruitingPhase 1IIT

A Phase 1 Study With a Pilot Expansion Phase of Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone (IoVeX) for Relapsed B-cell Acute Lymphoblastic Leukemia (B-ALL)

The goal of this clinical trial is to learn if the combination of drugs Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone (IoVeX) are safe to treat relapsed B-cell Acute Lymphoblastic Leukemia (B-ALL) in pediatric and adult patients. It will also learn if these drugs are well tolerated. The main questions it aims to answer are:
Is the drug combination of Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone (IoVeX) safe when given to patients?
What medical problems do patients taking IoVeX experience?
Participants will:
Receive this combination of drugs for 1 cycle which is 28 days at various timepoints. If participants tolerate cycle 1 they will be eligible to continue to cycle 2 which is also 28 days.
Have checkups and tests at the beginning of the study and throughout the course of each cycle.

Start Date21 May 2025

Sponsor / Collaborator

Children's Hospital & Medical Center

NCT06861348

/ Not yet recruitingPhase 2IIT

Effectiveness and Safety of Inotuzumab Ozogamicin±Donor Lymphocyte Infusion for Relapsed B Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma After Allogeneic Hematopoietic Stem Cell Transplantation：Phrase II, Multicenter Study

B cell acute lymphoblastic leukemia (B-ALL)/Lymphoblastic lymphoma (LBL) is a hematological malignancy caused by malignant transformation and clonal expansion of B-lineage precursor cells. Allogeneic hematopoietic stem cell transplantation (allo-HSCT) remains a potential curable therapy for ALL, especially for high-risk ALL patients. However, post-HSCT recurrence is the primary cause of transplant failure and salvage treatment option for this patient population are very limited. Current data showed that the CR rate and overall survival (OS) in adults with ALL who relapse after transplantation are as low as 30% and 25%, respectively, and the prognosis is extremely dismal. Some researchers have successfully salvage treated relapsed B-ALL patients after transplantation with donor lymphocyte infusions (DLI), but the response rate of DLI alone is usually less than 10%, with increased risk of Graft-Versus-Host Disease (GvHD). In the immunotherapy era, the introduction of immuno-designed therapies like bispecific antibody constructs, antibody conjugates, as well as chimeric antigen receptor T cell (CAR-T) therapy, have immensely broadened the treatment landscape of relapsed or refractory (r/r) B-ALL. Inotuzumab ozogamicin (InO) is a CD22-targeted monoclonal antibody conjugated to the cytotoxic antibiotic calicheamicin. Based on the pivotal Phase III INO-VATE clinical trial published in N Engl J Med in 2016, compared to standard chemotherapy, 73% (64/88) of r/r B-ALL patients treated with InO achieved CR/CRi in the first cycle. Superior CR duration, OS and relapse free survival (RFS) was also observed in the InO group. Subgroup analysis showed that the treatment benefits were consistent for patients who relapsed after allo-HSCT. Moreover, a single-center retrospective study attempted to salvage treat relapsed B-ALL patients after transplantation with combined InO and DLI, results showed that six out of eight patients achieved CR after the first InO course and 75% of patients obtained MRD negativity after the second course, which is quite satisfactory. Therefore, we designed a Phase II clinical study of InO combined with or without DLI in patients with recurrent acute B-ALL/LBL after allo-HSCT, with expectation to increase CR rate and improve long-term survival.

Start Date01 Mar 2025

Sponsor / Collaborator

The First Affiliated Hospital, Zhejiang University Sch of Med

100 Clinical Results associated with Inotuzumab Ozogamicin

100 Translational Medicine associated with Inotuzumab Ozogamicin

100 Patents (Medical) associated with Inotuzumab Ozogamicin

423

Literatures (Medical) associated with Inotuzumab Ozogamicin

01 Dec 2025·Blood Research

Atypical features of hepatic veno-occlusive disease/sinusoidal obstruction syndrome after inotuzumab ozogamicin in adult patients with acute lymphoblastic leukemia

Review

Author: Sung, Kyung-Hun ; Min, Gi June ; Eom, Ki-Seong ; Park, Sung-Soo ; Lee, Sung-Eun ; Cho, Byung-Sik ; Cho, Seok-Goo ; Kim, Hee-Je ; Lee, Seok ; Park, Silvia ; Kim, Yoo-Jin ; Kwag, Daehun ; Min, Chang-Ki ; Yoon, Jae-Ho

Abstract:

Purpose:

Inotuzumab ozogamicin (INO) has demonstrated a safe bridging role to allogeneic hematopoietic stem cell transplantation (HSCT) in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL). However, hepatic veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS) is frequently observed. This study aimed to identify significant features of INO-associated VOD/SOS.

Methods:

We reviewed seven cases of hepatic VOD/SOS that developed either during INO salvage or after allogeneic HSCT following INO-induced complete remission (CR). Diagnosis and severity grading of VOD/SOS were based on the revised criteria from the European Society for Blood and Marrow Transplantation. Defibrotide was used to treat severe to very severe cases.

Results:

Four patients developed VOD/SOS during INO salvage therapy (at 21 and 36 days post-INO1, 77 days post-INO3, and 21 days post-INO5), while three were diagnosed at 2, 5, and 10 days post-HSCT following INO-induced CR. Doppler ultrasonography revealed preserved portal vein flow (range 10.2–26.0 cm/sec) and normal hepatic artery resistive index (RI, range 0.56–0.74) in all but one patient (RI 0.83). Despite this, all patients presented with massive ascites and progressively elevated total bilirubin levels. All cases were classified as severe to very severe; six were treated with defibrotide and one underwent liver transplantation. Most patients ultimately died owing to VOD/SOS progression.

Conclusion:

Post-INO VOD/SOS manifested as two different clinical settings and was characterized by preserved portal vein flow, which complicated diagnosis. Despite timely defibrotide administration, clinical outcomes were poor. These findings emphasize the need for vigilance and potential consideration of prophylactic strategies for prevention of INO-associated VOD/SOS.

01 Aug 2025·INTERNATIONAL JOURNAL OF HEMATOLOGY

Differences in response to immunotherapy drugs including blinatumomab and inotuzumab ozogamicin in B-ALL patients

Article

Author: An, Ran ; Zhang, Su-Jiang ; Liu, Zhi-Yin ; Wang, Ying ; Bao, Wei-Ying ; Tian, Jie ; Yan, Ze-Ying ; Xu, Xiao-Qian ; Chen, Li ; Zhu, Yong-Mei ; Sun, Hai-Min ; Yang, Guang ; Li, Jian-Feng

The treatment of B-cell precursor acute lymphoblastic leukemia (B-ALL) has undoubtedly transitioned into the immunotherapy era. We conducted a retrospective study on B-ALL immunotherapy, especially regimens including blinatumomab (Blina) and inotuzumab ozogamicin (InO), at our center. A total of 21 B-ALL patients were involved in this study, including 18 with newly diagnosed (ND) B-ALL and 3 with relapsed B-ALL. RNA sequencing identified a total of five new fusions (ADD1::JAK2, PVT1::IGLL5, PAX5::KANK2, ETV6::BCL2L14, and CDKN2A::TGFBR3) in five different patients. All ND patients can be divided into four groups according to treatment response. Group 1, which included patients with PAX5::KANK2 and CREBBP::ZNF384, responded best to Blina. Group 2, which included one patient with CDKN2A::TGFBR3 fusion and one who was BCR::ABL positive, showed an inferior response to Blina compared with Group 1. Group 3 initially showed no response but subsequently responded very favorably to InO and showed further improvement with Blina. Group 4, which included patients with PVT1::IGLL5 fusion, had the poorest prognosis. In conclusion, Blina and InO showed specific treatment advantages for different patient groups in our cohort that may be attributed to intrinsic genetic characteristics, such as new fusion genes.

24 Jul 2025·BLOOD

Differentiation-dependent EBF1 activity determines CD22 transcription and leukemia sensitivity to inotuzumab ozogamicin

Article

Author: Barnett, Kelly R. ; Walker, Megan ; Yoshimura, Satoshi ; Li, Zhenhua ; Yang, Jun J. ; Yu, Jiyang ; Stock, Wendy ; Paietta, Elisabeth ; Loh, Mignon L. ; Kornblau, Steven M. ; Huang, Xin ; Pui, Ching-Hon ; Li, Yizhen ; Escherich, Carolin S. ; Evans, William E. ; Savic, Daniel ; Konopleva, Marina Y. ; Litzow, Mark R. ; Inaba, Hiroto ; Jabbour, Elias ; Yang, Wenjian

Abstract:

Inotuzumab ozogamicin (InO) is an antibody-calicheamicin conjugate with high efficacy in lymphoid malignancies. It targets the B-cell surface protein CD22, which is expressed in most B-cell acute lymphoblastic leukemia (B-ALL) cases, albeit with variable intensity. However, factors governing CD22 expression and thus leukemia sensitivity to InO remain incompletely understood. Using multiomic characterization of 196 human B-ALL samples, coupled with ex vivo InO sensitivity profiling, we showed that early leukemia differentiation arrest at the pre–pro-B stage is associated with resistance to InO. Screening of 1639 transcription factor genes identified early B-cell factor 1 (EBF1) as a key regulator of CD22 expression (false discovery rate of 7.1 × 10−4). When comparing the assay for transposase-accessible chromatin with sequencing profiling results of the most InO-sensitive and -resistant cases (50% lethal concentration <10th vs >90th percentile, n = 18), the binding motif for EBF1 was strikingly enriched in regions with differential open chromatin status (P = 8 × 10−174). CRISPR interference targeting EBF1 binding sites at the CD22 locus led to an ∼50-fold reduction in cell surface CD22 expression and, consequently, an ∼22-fold increase in InO resistance in ALL cell lines. Interestingly, within BCR::ABL1 ALL, we observed intrasubtype heterogeneity linked to EBF1 transcriptional downregulation (P = 1.1 × 10−15) and/or somatic alteration (P = .004), which led to reduced CD22 expression (P = 8.3 × 10−11) and ex vivo and in vivo resistance to InO. Collectively, these findings point to the direct impact of EBF1 on CD22 expression during B-cell development, which, in turn, contributes to interpatient variability in InO response, even within the same subtype of B-ALL.

News (Medical) associated with Inotuzumab Ozogamicin

09 Jun 2025

·www.einpresswire.com

Thirteen Studies of Ascentage Pharma’s Assets Including Olverembatinib and Lisaftoclax Selected for Presentations at 2025 European Hematology Association Annual Congress

ROCKVILLE, Md. and SUZHOU, China, June 09, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855), a global biopharmaceutical company dedicated to addressing unmet medical needs in cancers, announced that 13 studies of its core assets - including the novel drug olverembatinib (HQP1351), the investigational Bcl-2 inhibitor lisaftoclax (APG-2575), and the investigational EED inhibitor APG-5918 – will be featured in an oral presentation, multiple poster presentations and multiple online publications at the 2025 European Hematology Association (EHA) Annual Congress taking place in Milan, Italy, from June 12-15, 2025. The EHA Annual Congress is the largest gathering of the hematology community in Europe. Attracting more than 10,000 attendees from more than 100 countries every year, the congress showcases cutting-edge research and ground-breaking clinical results in the field of hematology. Oral Presentation Integrating Genomic and Transcriptomic Insights for Predicting Responses and Outcomes in Patients with CML Receiving 3rd-Generation TKI Therapy Abstract#: S162 Session: Biology of CML treatment response and resistance Date and Time: Saturday, 14 June, 17:30-17:45 CEST / Saturday, 14 June, 23:30-23:45 Beijing Time Principal Authors: Prof. Qian Jiang, Peking University People’s Hospital; Dr. Xiaoshuai Zhang, Peking University People’s Hospital Poster Presentations Frontline Chemotherapy-Free Combination of Olverembatinib with Venetoclax and Azacitidine in Newly Diagnosed Ph+ Acute Lymphoblastic Leukemia: Preliminary Outcomes of a Prospective Study Abstract#: PF384 Session: Acute lymphoblastic leukemia – Clinical Date and Time: Friday, 13 June, 18:30-19:30 CEST / Saturday, 14 June, 00:30-01:30 Beijing Time Principal Author: Prof. Xiaowen Tang, The First Affiliated Hospital of Soochow University; Xin Zhang, The First Affiliated Hospital of Soochow University A Phase 2 Study of Olverembatinib for the Treatment of Myeloid/Lymphoid Neoplasms with FGFR1 Rearrangement Abstract#: PF390 Session: Acute lymphoblastic leukemia – Clinical Date and Time: Friday, 13 June, 18:30-19:30 CEST / Saturday, 14 June, 00:30-01:30 Beijing Time Principal Authors: Prof. Suning Chen, The First Affiliated Hospital of Soochow University; Wenzhi Cai, The First Affiliated Hospital of Soochow University Efficacy and Safety of Regimen with Olverembatinib and Blinatumomab for the Frontline Treatment of Ph-Positive or Ph-Like Acute Lymphoblastic Leukemia Abstract#: PS1367 Session: Acute lymphoblastic leukemia – Clinical Date and Time: Saturday, 14 June, 18:30-19:30 CEST / Sunday, 15 June, 00:30-01:30 Beijing Time Principal Authors: Prof. Hongsheng Zhou, Nanfang Hospital, Southern Medical University; Xiuli Xu, Nanfang Hospital, Southern Medical University Combination of Olverembatinib and VP Regimen as First-Line Therapy for Adult Patients with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: A Single-Arm, Multicentre, Phase 2 Trial Abstract#: PS1372 Session: Acute lymphoblastic leukemia – Clinical Date and Time: Saturday, 14 June, 18:30-19:30 CEST / Sunday, 15 June, 00:30-01:30 Beijing Time Principal Authors: Prof. Jie Jin, The First Affiliated Hospital, Zhejiang University School of Medicine; Dr. Gaixiang Xu, The First Affiliated Hospital, Zhejiang University School of Medicine Efficacy and Safety of The Third-Generation Tyrosine Kinase Inhibitor Olverembatinib in Combination with Inotuzumab Ozogamicin for the Treatment of Adult Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Patients With Relapsed Disease or Persistent Minimal Residual Disease Bridging to Hematopoietic Stem Cell Transplantation: A Phase II Study Abstract#: PS1387 Session: Acute lymphoblastic leukemia – Clinical Date and Time: Saturday, 14 June, 18:30-19:30 CEST / Sunday, 15 June, 00:30-01:30 Beijing Time Principal Author: Erlie Jiang, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College; Xiaoyu Zhang, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College Embryonic Ectoderm Development (EED) Inhibitor APG-5918 Exhibits Potent Antitumor Activity and Synergizes with Histone Deacetylase Inhibitor Tucidinostat in Preclinical T-Cell Lymphoma (TCL) Models Abstract#: PS1993 Session: Lymphoma biology & translational research Date and Time: Saturday, 14 June, 18:30-19:30 CEST / Sunday, 15 June, 00:30-01:30 Principal Author: Dr. Eric Liang, Ascentage Pharma Group Inc. Online Publications Alternating Low-Dose Inotuzumab Ozogamicin and Blinatumomab in Maintenance Therapy for Ph+ ALL: A Single-Center Retrospective Analysis Abstract: PB2384 Principal Author: Prof. Zi-Yuan Nie, The Second Hospital of Hebei Medical University Efficacy and Safety of Blinatumomab in Newly-Diagnosed Patients with Ph-Positive/Negative B-Cell Acute Lymphoblastic Leukemia Abstract#: PB2363 Principal Author: Yinqiang Zhang, Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Efficacy and Safety of the Third-Generation TKI Olverembatinib in Relapsed and Persistent MRD Positive Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Patients Abstract#: PB2360 Principal Author: Xinwen Jiang, The Second Hospital of Hebei Medical University Clinical Features and Genetic Abnormalities Predict Outcomes in Patients with Chronic Myeloid Leukemia in the Accelerated-Phase Receiving Olverembatinib Therapy: A Retrospective Multicenter Study Abstract#: PB2701 Principal Author: Mengyao Yuan, Peking University People's Hospital A Real-World Study of Olverembatinib in the Treatment of Chronic Myeloid Leukemia from China: A Single-Center Retrospective Study Abstract#: PB2714 Principal Author: Tian Dong, West China Hospital of Sichuan University Synergistic Effects of Olverembatinib (HQP1351) Combined with Bcl-2 Inhibitor Lisaftoclax (APG-2575) and Bcl-2/Bcl-xL Inhibitor Pelcitoclax (APG-1252) in T-Cell Acute Lymphoblastic Leukemia (T-ALL) Abstract#: PB2341 Principal Author: Bo Peng, Ascentage Pharma (Suzhou) Co., Ltd. About Ascentage Pharma Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855) is a global biopharmaceutical company dedicated to addressing unmet medical needs in cancers. The company has built a rich pipeline of innovative drug candidates that includes inhibitors targeting key proteins in the apoptotic pathway, such as Bcl-2 and MDM2-p53 and next-generation kinase inhibitors. The lead asset, olverembatinib, is the first novel third-generation BCR-ABL1 inhibitor approved in China for the treatment of patients with CML in chronic phase (CML-CP) with T315I mutations, CML in accelerated phase (CML-AP) with T315I mutations, and CML-CP that is resistant or intolerant to first and second-generation TKIs. It is covered by the China National Reimbursement Drug List (NRDL). The Company is currently conducting an FDA-cleared, global registrational Phase III trial, or POLARIS-2, of olverembatinib for CML, as well as global registrational Phase III trials for newly diagnosed Ph + ALL patients and SDH-deficient GIST patients. The second lead asset, lisaftoclax, is a novel Bcl-2 inhibitor for the treatment of various hematologic malignancies. The NDA for the treatment of relapsed and/or refractory CLL and SLL was accepted with Priority Review designation by China’s National Medical Products Administration. The Company is currently conducting an FDA-cleared, global registrational Phase III trial, or GLORA, of lisaftoclax in combination with BTK inhibitors for patients with CLL/SLL previously treated with BTK inhibitors for more than 12 months with suboptimal response, as well as global registrational Phase III trials for newly diagnosed CLL/SLL, AML, and MDS patients. Leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships and other relationships with numerous leading biotechnology and pharmaceutical companies, such as Takeda, AstraZeneca, Merck, Pfizer, and Innovent, in addition to research and development relationships with leading research institutions, such as Dana-Farber Cancer Institute, Mayo Clinic, National Cancer Institute and the University of Michigan. For more information, visit https://ascentage.com/ Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, contained in this press release may be forward-looking statements, including statements that express Ascentage Pharma’s opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results of operations or financial condition. These forward-looking statements are subject to a number of risks and uncertainties as discussed in Ascentage Pharma’s filings with the SEC, including those set forth in the sections titled “Risk factors” and “Special note regarding forward-looking statements and industry data” in its Registration Statement on Form F-1, as amended, filed with the SEC on January 21, 2025, and the Form 20-F filed with the SEC on April 16, 2025, the sections headed “Forward-looking Statements” and “Risk Factors” in the prospectus of the Company for its Hong Kong initial public offering dated October 16, 2019, and other filings with the SEC and/or The Stock Exchange of Hong Kong Limited we made or make from time to time that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. The forward-looking statements contained in this presentation do not constitute profit forecast by the Company’s management. As a result of these factors, you should not rely on these forward-looking statements as predictions of future events. The forward-looking statements contained in this press release are based on Ascentage Pharma’s current expectations and beliefs concerning future developments and their potential effects and speak only as of the date of such statements. Ascentage Pharma does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Contacts Investor Relations: Hogan Wan, Head of IR and Strategy Ascentage Pharma Hogan.Wan@ascentage.com +86 512 85557777 Stephanie Carrington ICR Healthcare Stephanie.Carrington@icrhealthcare.com +1 (646) 277-1282 Media Relations: Sean Leous ICR Healthcare Sean.Leous@icrhealthcare.com +1 (646) 866-4012 Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Phase 2Phase 3Priority ReviewNDA

04 Feb 2025

·pharma.economictimes.indiatimes.com

Can Custom Duty exemptions alleviate the high-price burden for cancer patients?

New Delhi: With more than 1.5 million active cases across the country, the prevalence of cancer in India has certainly outpaced the available treatment interventions. However, what makes the situation even worse is the sky-high cost of treatment, which makes these therapies inaccessible to many patients, leaving them in a desperate struggle to secure financial aid and loans for life-saving medicines. A walk around Mumbai’s Tata Memorial Hospital, India’s premium cancer care institution, shows the appalling situation. T he entrance is always overflowing with patients from across the country, while many managing to live in makeshift shelters in extreme financial distress to cope with costs of treatment. A study showed a small fraction of Indians, roughly 3 per cent can afford expensive immunotherapies in India, making it a big challenge for public health establishments to reach modern medicines to the low income strata. To confront this growing crisis, the government has opted for a strategy of waiving customs duties on life-saving medications, thereby reducing import costs and hoping to translate these savings into more affordable treatment options for patients. The Finance Minister said in her Budget 2025 speech, “To provide relief to patients, particularly those suffering from cancer, rare diseases, and other severe chronic conditions, I propose to add 36 life-saving drugs and medicines to the list of medicines fully exempted from Basic Customs Duty .” She also proposed to add “six life-saving medicines to the list attracting a concessional customs duty of 5 percent.” The government order states, “In exercise of the powers conferred by sub-section (1) of section 25 of the Customs Act, 1962 (52 of 1962), the Central Government, on being satisfied that it is necessary in the public interest to do so,” has exempted Basic Customs Duty on 36 life-saving medications. A rough analysis of the list shows that out of the 36 medications, 25 are indicated for the treatment of various types of cancer. Feb 4, World Cancer Day , is the perfect time to assess whether exempting customs duties could make a significant difference to patient expenses. The majority of these drugs are protected by patents, granting them global exclusivity, and are marketed by major pharmaceutical giants such as Merck, Roche, GSK, and AstraZeneca. Strikingly, in the previous Budget 2024, the government announced the exemption of customs duty on three cancer drugs—Osimertinib, Durvalumab, and Trastuzumab Deruxtecan. The first two medications are indicated for lung cancer, while the latter is used in the treatment of breast cancer. All three are marketed by UK pharma giant AstraZeneca. According to the government, “Drugs/medicines generally attract a basic customs duty of 10 percent, while some categories of life-saving drugs/vaccines attract a concessional rate of 5 percent or nil.” The Basic Customs Duty (BCD) is calculated over the customs value, which is the accumulation of the CIF cost where C represents the cost of goods, I stands for insurance, and F accounts for freight or logistics costs. Besides BCD, the government levies a social welfare surcharge of 10 per cent, calculated over the BCD value, and a 5 per cent Integrated Goods and Services Tax (IGST), calculated over the accumulated figure of CIF value and BCD of the imported goods. Speaking to ET Pharma, Leena Menghaney, a lawyer and public health activist, stressed, “The customs duty waiver on some of the exorbitantly priced cancer and rare disease drugs is a welcome move, but it is like a band-aid and does not address the underlying problem of high prices due to patent monopolies that block local production.” “India is a country where half the population lives on less than $1 per day and bears a large public health burden for cancers. How can patients pay for patented medicines like Keytruda ?” she added. While industry stakeholders are still analysing the net impact of the announcement, Dr.B. S. Ajaikumar, Executive Chairman of Healthcare Global Enterprises Limited, said, “The exemption of customs duty will have an impact of 5-10 percent on the price of drugs, and this development will primarily benefit cash-paying patients, with some benefit extending to those utilizing insurance.” Bhanu Prakash Kalmath, a consultant at Grant Thornton Bharat LLP, underlined, “The final reduction will depend on manufacturers, hospitals, and supply chains. This move directly reduces import costs and supports broader access to essential treatments. It also benefits insurance providers, government health schemes like Ayushman Bharat , and Patient Assistance Programs (PAPs).” Under the Patient Assistance Programs (PAP) offered by pharmaceutical companies, medicines are provided in 1+1 or 2+1 packages, where the patient pays for one or two drugs and receives an additional one free of cost. However, under the condition of anonymity, an expert shared that very few patients in the country are currently covered under PAP programs. Additionally, at times, the last-stage providers (mostly hospitals) that stock these drugs apply a profit margin over the products. Furthermore, it is crucial to note that while the Finance Minister’s announcement has exempted customs duties, patients still have to contend with the Maximum Retail Price (MRP) of drugs. The MRP is compiled based on several other costs, as post-import, the product often requires special storage, handling, and packaging before distribution to retail outlets. The distribution costs include transportation to wholesalers and retail outlets, along with the distributor’s margin. To make novel treatments truly affordable for the Indian demographic, Menghaney emphasised, “The country needs to boost local production and competition by granting a compulsory license clause. This would cut the cost of the drug by allowing another company to manufacture the therapy, even though it is still under patent.” “In the past, such measures have slashed prices by introducing local generic versions of cancer drugs—by an astounding 97 percent,” she added. The high price of cancer drugs has long been a contentious issue across low- and middle-income countries (LMICs), including India. However, given the scale and severity of the problem, it categorically requires a more holistic solution—one that ensures benefits are truly materialized for patients. As philanthropist Bill Gates once said, “The good news is that we have the tools to prevent most diseases. But the bad news is that not enough people are getting them.” List of Cancer Drugs to exempted from BCD under Budget 2025-26 S. No. Drug Company Brand Name MRP (INR) 1. Pembrolizumab MSD (Merck, Sharp & Dohme) Keytruda 2,16,500 2. Lorlatinib Pfizer Lorbrena 10,400 3. Dacomitinib Pfizer Vizimpro 2,135 4. Inotuzumab Ozogamicin Pfizer Besponsa 3,30,000 5. Ribociclib Novartis Kisqali 1,125 6. Dabrafenib Novartis Tafinlar 1,516 7. Selumetinib AstraZeneca Koselugo - 8. Fulvestrant AstraZeneca Faslodex 21,100 9. Acalabrutinib AstraZeneca Calquence 15,147 10. Olaparib AstraZeneca Lynparza 5,416 11. Amivantamab J&J Rybrevant 98,500 12. Teclistamab J&J Tecvayli 76,218 13. Daratumumab and hyaluronidase-fih J&J Darzalex Faspro 2,64,600 14. Ibrutinib J&J Imbruvica 3,644 15. Bortezomib J&J Velcade 18,060 16. Daratumumab J&J Darzalex 18,900 17. Cetuximab Merck Specialties (Merck KGaA) Erbitux 21,250 18. Avelumab Merck Specialties Bavencio - 19. Tepotinib Merck Specialties Tepmetko 5,094 20. Brentuximab Vedotin Takeda Adcetris 2,22,709 21. Vedolizumab Takeda Entyvio - 22. Atezolizumab Roche Tecentriq 2,77,708 23. Pertuzumab+trastuzumab Roche Phesgo 2,80,000 24. Polatuzumab vedotin Roche Polivy 2,22,225 25. Alectinib Roche Alecensa 2,215 Note* the above price is without any deduction and of lowest dosage strength as some of the drugs are available in multiple strengths and their prices also very depending upon that particular strength. By Abhijeet Singh ,

ImmunotherapyBiosimilar

01 Feb 2025

·pharma.economictimes.indiatimes.com

Govt Attempts to Overcome High-Price Challenge by Exempting Basic Customs Duty in Budget 2025

New Delhi : Continuing its focus on addressing the challenge of skyrocketing drug prices , the Finance Minister, in her eighth Budget speech for the fiscal year 2025-26, announced a full exemption of basic customs duty (BCD) for 36 life-saving medications indicated for critical conditions such as cancer, autoimmune diseases, and rare disorders. “To provide relief to patients, particularly those suffering from cancer, rare diseases, and other severe chronic conditions, I propose to add 36 lifesaving drugs and medicines to the list of medicines fully exempted from Basic Customs Duty,” the Finance Minister said in her Budget speech. Previously, the exemption of BCD on these drugs was conditional on their availability free of cost under drug companies' Patient Assistance Programmes (PAP). Among these 36 medications, 25 are indicated for the treatment of different types of cancer, five are prescribed for rare disorders, two for respiratory diseases, three for autoimmune conditions, and one is used in the treatment of retinal diseases. The majority of these drugs are protected by patents, granting them global exclusivity, and are marketed by major pharmaceutical giants such as Merck, Roche, GSK, and AstraZeneca. Notably, in the previous Budget, the government announced the exemption of customs duty on three cancer drugs—Osimertinib, Durvalumab, and Trastuzumab Deruxtecan. The first two medications are indicated for lung cancer, while the latter is used in the treatment of breast cancer patients. Sharing his views on this announcement, Arjun Juneja, COO of Mankind Pharma, said, “The exemption of Basic Customs Duty on 36 life-saving drugs makes critical treatments, especially for oncology and rare diseases, more affordable. It aligns with the government’s vision of a self-reliant India, lays a solid foundation for the pharmaceutical sector , and enhances healthcare accessibility .” “The addition of 36 life-saving drugs to the list of medicines fully exempted from basic customs duty, along with six more medicines under concessional duty, will significantly reduce treatment costs for patients,” added DS Negi, CEO of Rajiv Gandhi Cancer Institute & Research Centre (RGCIRC). Commenting on its impact on patients, Dr. Tarang Gianchandani, CEO of Sir H.N. Reliance Foundation, said, “The basic customs duty exemption on 36 life-saving drugs, including those for cancer and rare diseases, ensures that critical treatments remain within reach for countless patients and their families, bringing hope.” List of 36 Medications given BCD Exemptions: S.No. Drug Company Clinical Indication 1. Pembrolizumab MSD (Merck, Sharp & Dohme) Cancer 2. Lorlatinib Pfizer Cancer 3. Dacomitinib Pfizer Cancer 4. Inotuzumab Ozogamicin Pfizer Cancer 5. Ribociclib Novartis Cancer 6. Dabrafenib Novartis Cancer 7. Selumetinib AstraZeneca Cancer 8. Fulvestrant AstraZeneca Cancer 9. Acalabrutinib AstraZeneca Cancer 10. Olaparib AstraZeneca Cancer 11. Amivantamab J&J Cancer 12. Teclistamab J&J Cancer 13. Daratumumab and hyaluronidase-fih J&J Cancer 14. Ibrutinib J&J Cancer 15. Bortezomib J&J Cancer 16. Daratumumab J&J Cancer 17. Cetuximab Merck Specialties (Merck KGaA) Cancer 18. Avelumab Merck Specialties Cancer 19. Tepotinib Merck Specialties Cancer 20. Brentuximab Takeda Cancer 21. Vedolizumab Takeda Cancer 22. Atezolizumab Roche Cancer 23. Pertuzumab+trastuzumab Roche Cancer 24. Polatuzumab vedotin Roche Cancer 25. Alectinib Roche Cancer 26. Benralizumab Astrazeneca Respiratory Disease (Asthma) 27. Mepolizumab GSK Respiratory Disease (Severe Asthma) 28. Ustekinumab J&J Autoimmune Disease (Psorasis) 29. Ocrelizumab Roche Autoimmune Disease (Multiple sclerosis) 30. Luspatercepto Bristol Myers Squibb Autoimmune Disease (Anemia) 31. Velaglucerase Takeda Rare Disorder (Type 1 Gaucher disease) 32. Agalsidase Alpha Takeda Rare Disorder (Fabry disease) 33. Idursulphase Takeda Rare Disorder (Hunter syndrome) 34. Risdiplam Powder Roche Rare Disorder (SMA) 35. Emicizumab Roche Rare Disorder (Hemophillia) 36. Faricimab Roche Retinal Disease By Online Bureau ,

100 Deals associated with Inotuzumab Ozogamicin

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KEGG	Wiki	ATC	Drug Bank
D08933	Inotuzumab Ozogamicin	L01XC26	DB05889

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Philadelphia chromosome positive adult precursor acute lymphoblastic leukemia	United Kingdom	Pfizer Inc.	01 Jan 2021
Pre B-cell acute lymphoblastic leukemia	United Kingdom	Pfizer Inc.	01 Jan 2021
Recurrent B Acute Lymphoblastic Leukemia	South Korea	Pfizer Pharmaceuticals Korea Ltd.	03 Jan 2019
Refractory B Acute Lymphoblastic Leukemia	South Korea	Pfizer Pharmaceuticals Korea Ltd.	03 Jan 2019
CD22 Positive B-cell Acute Lymphoblastic Leukemia	Australia	Pfizer (Perth) Pty Ltd.	17 May 2018
Acute Lymphoblastic Leukemia	Japan	Pfizer Inc.	19 Jan 2018
Precursor B-Cell Lymphoblastic Leukemia-Lymphoma	United States	Wyeth Pharmaceuticals LLC	17 Aug 2017
CD22-positive B-cell Precursor acute lymphoblastic leukemia	European Union	Pfizer Europe MA EEIG	28 Jun 2017
CD22-positive B-cell Precursor acute lymphoblastic leukemia	Iceland	Pfizer Europe MA EEIG	28 Jun 2017
CD22-positive B-cell Precursor acute lymphoblastic leukemia	Liechtenstein	Pfizer Europe MA EEIG	28 Jun 2017
CD22-positive B-cell Precursor acute lymphoblastic leukemia	Norway	Pfizer Europe MA EEIG	28 Jun 2017

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
CD22 positive Acute Lymphoblastic Leukemia	Phase 3	United States	Pfizer Inc.	02 Aug 2012
CD22 positive Acute Lymphoblastic Leukemia	Phase 3	United States	UCB SA	02 Aug 2012
CD22 positive Acute Lymphoblastic Leukemia	Phase 3	China	UCB SA	02 Aug 2012
CD22 positive Acute Lymphoblastic Leukemia	Phase 3	China	Pfizer Inc.	02 Aug 2012
CD22 positive Acute Lymphoblastic Leukemia	Phase 3	Japan	Pfizer Inc.	02 Aug 2012
CD22 positive Acute Lymphoblastic Leukemia	Phase 3	Japan	UCB SA	02 Aug 2012
CD22 positive Acute Lymphoblastic Leukemia	Phase 3	Argentina	UCB SA	02 Aug 2012
CD22 positive Acute Lymphoblastic Leukemia	Phase 3	Argentina	Pfizer Inc.	02 Aug 2012
CD22 positive Acute Lymphoblastic Leukemia	Phase 3	Australia	UCB SA	02 Aug 2012
CD22 positive Acute Lymphoblastic Leukemia	Phase 3	Australia	Pfizer Inc.	02 Aug 2012

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO2025	Not Applicable	Recurrent Childhood Acute Lymphoblastic Leukemia	52	Inotuzumab ozogamicin	vlonbzslqc(okmwhmtaoj) = yjnzsuiytw vkqndlwnca (rahexkgcxb ) View more	Positive	30 May 2025
ASCO2025	Not Applicable	CD19-positive B-cell Precursor acute lymphoblastic leukemia	338	inotuzumab ozogamicin (<25 kg/m^2)	gbpuntcxpt(jnggyhygvl) = sotzbiukxa mxfgneabxc (vovjbhjwyy ) View more	Positive	30 May 2025
				inotuzumab ozogamicin (25-30 kg/m^2)	gbpuntcxpt(jnggyhygvl) = bpfugcfdaj mxfgneabxc (vovjbhjwyy ) View more
PS1394 (EHA2025)	Phase 1/2	CD19-positive B-cell Precursor acute lymphoblastic leukemia	338	Inotuzumab ozogamicin	dttrrkpolu(jjupqkvsvn) = qlxsgmbfck lykauieaow (gobnhcowxn ) View more	Positive	14 May 2025
				Inotuzumab ozogamicin (BMI <25 kg/m^2)	dttrrkpolu(jjupqkvsvn) = yvudmmrdmm lykauieaow (gobnhcowxn ) View more
Phase 4 Trial (EHA2025)	Phase 4	Acute Lymphoblastic Leukemia CD22-positive \| Ph+ or Ph-	44	Inotuzumab ozogamicin 0.8 mg/m^2	yctmtzhtag(mekjczvgul) = kktrhyvufg nyjrsceujo (kpcymfypge, 70.4 - 93.2) View more	Positive	14 May 2025
GRELAL-CHILE (EHA2025)	Not Applicable	Recurrent Childhood Acute Lymphoblastic Leukemia CD22 \| CD19	35	Inotuzumab Ozogamicin	qknsxjdcqm(tersaeopms) = 82% of them had <0.01% vnasyohhqg (touiituugm ) View more	-	14 May 2025
				Inotuzumab ozogamicin (Allogeneic Hematopoietic Stem Cell Transplant)
PB2358 (EHA2025)	Not Applicable	Burkitt Lymphoma	39	Inotuzumab Ozogamicin	amdoknxgoj(npjwcamhuc) = iodxberlku yorzyxmzcd (knchpbwmdq ) View more	-	14 May 2025
				TKI	amdoknxgoj(npjwcamhuc) = ndbngqxvoe yorzyxmzcd (knchpbwmdq ) View more
ITCC-059 (EHA2025)	Phase 2	CD22-positive B-cell Precursor acute lymphoblastic leukemia CD22-positive \| KTM2A::AF4 \| E2A::PBX1 ... View more	45	Inotuzumab Ozogamicin	dsdzzzhwda(fgfmiekkbu) = hatjflheia crtkuqglzc (tsdghilbch, 52 - 86) View more	Positive	14 May 2025
PB2384 (EHA2025)	Not Applicable	Ph-Like Acute Lymphoblastic Leukemia Maintenance CD19 \| CD3 \| CD22	4	Blinatumomab	xjxvqnklkj(vcfccokfvl) = oulbgreeoj nxugfaviyc (rcadfhrqky )	Positive	14 May 2025
				Inotuzumab Ozogamicin	xjxvqnklkj(vcfccokfvl) = wfwoqrrfeu nxugfaviyc (rcadfhrqky )
S111 (EHA2025)	Not Applicable	CD19-positive B-cell Precursor acute lymphoblastic leukemia	338	≤3.3 mg/m^2 Inotuzumab ozogamicin	kpsxxshcuj(ghakknvsia) = pnnsflhgot cvdmyaynks (njtcxkzuma ) View more	Positive	14 May 2025
				>3.3 mg/m^2 Inotuzumab ozogamicin	kpsxxshcuj(ghakknvsia) = eaxlihbraq cvdmyaynks (njtcxkzuma ) View more
PF393 (EHA2025)	Not Applicable	Acute Lymphoblastic Leukemia	52	Inotuzumab ozogamicin	cqckqghpqp(rjhsdxukhf) = weshrnqvpr qztpycengm (yxwxbeveal ) View more	-	14 May 2025
				Defibrotide	cipdknrdpz(tuukobbkro) = axiwhlktew nhadcirndy (nxraggrrve )

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