Delving into the Latest Updates on Bleomycin Sulfate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Bleomycin sulfate (JP17/USP), BLM-S, NK-630.6

+ [5]

Target-

Action

inhibitors

Mechanism

DNA synthesis inhibitors

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal Diseases

Active Indication

Basal Cell NeoplasmsSkin Neoplasms

Inactive Indication

Head and Neck NeoplasmsLymphomaMalignant Pleural Effusion+ [3]

Originator Organization

Bristol Myers Squibb Co.

Active Organization

Nippon Chemical

Nippon Kayaku Co., Ltd.

Inactive Organization

Bristol Myers Squibb Co.PCI Biotech AS

Inovio Pharmaceuticals, Inc.

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (31 Jul 1973),

LymphomaMalignant Pleural EffusionSquamous Cell Carcinoma+ [1]

RegulationOrphan Drug (United States)

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PRIMETEST II is an interventional study involving low-volume metastatic seminoma. It explores a novel approach using robot-assisted primary retroperitoneal lymph node dissection, aiming to reduce long-term side effects and improve quality of life. By identifying factors predicting cancer recurrence, the study hopes to tailor treatments for better outcomes. The approach could potentially spare patients from chemotherapy induced long-term side effects while maintaining excellent survival rates, presenting a promising shift in testicular cancer care for this specific patient group.

Start Date28 Aug 2023

Sponsor / Collaborator

Heinrich-Heine-Universität Düsseldorf

NCT05675410

/ RecruitingPhase 3IIT

A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy With Immuno-oncology Therapy for Children and Adults With Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma

This phase III trial compares the effect of adding immunotherapy (brentuximab vedotin and nivolumab) to standard treatment (chemotherapy with or without radiation) to the standard treatment alone in improving survival in patients with stage I and II classical Hodgkin lymphoma. Brentuximab vedotin is in a class of medications called antibody-drug conjugates. It is made of a monoclonal antibody called brentuximab that is linked to a cytotoxic agent called vedotin. Brentuximab attaches to CD30 positive lymphoma cells in a targeted way and delivers vedotin to kill them. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs such as doxorubicin hydrochloride, bleomycin sulfate, vinblastine sulfate, dacarbazine, and procarbazine hydrochloride 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. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Adding immunotherapy to the standard treatment of chemotherapy with or without radiation may increase survival and/or fewer short-term or long-term side effects in patients with classical Hodgkin lymphoma compared to the standard treatment alone.

Start Date11 May 2023

Sponsor / Collaborator

National Cancer Institute

NCT03596918

/ CompletedNot ApplicableIIT

Longitudinal Quality of Life Study Among Participants With AIDS-Associated Kaposi Sarcoma at Bugando Medical Centre, in Mwanza, Tanzania

This pilot phase I trial studies how well treatment with vincristine and bleomycin affect quality of life in patients with acquired immunodeficiency syndrome (AIDS)-associated Kaposi sarcoma.

Start Date10 Oct 2018

Sponsor / Collaborator

University of California, Los Angeles

[+3]

100 Clinical Results associated with Bleomycin Sulfate

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100 Translational Medicine associated with Bleomycin Sulfate

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100 Patents (Medical) associated with Bleomycin Sulfate

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169

Literatures (Medical) associated with Bleomycin Sulfate

16 Jan 2025·BLOOD

Brentuximab vedotin, nivolumab, doxorubicin, and dacarbazine for advanced-stage classical Hodgkin lymphoma

Article

Author: Melear, Jason ; Feldman, Tatyana A. ; Burke, John M. ; Rana, Vishal ; Ho, Linda ; Friedman, Judah ; Gonzales, Paul ; Patel, Ameet ; Yimer, Habte ; Gandhi, Mitul D. ; Chintapatla, Rangaswamy ; Guo, Wenchuan ; Flinn, Ian W. ; Dean, Asad ; Peterson, Matthew ; Yasenchak, Christopher A. ; Linhares, Yuliya ; Lee, Hun Ju ; Raval, Mihir ; Metheny, Leland ; Islas-Ohlmayer, Miguel ; Ramchandren, Rod ; Renshaw, John ; Fanale, Michelle A.

Abstract:

Treatment options for stage I/II bulky and advanced-stage disease have recently extensively changed. For decades in North America, ABVD (doxorubicin hydrochloride [Adriamycin], bleomycin sulfate, vinblastine sulfate, and dacarbazine) has been a frontline standard-of-care option for patients with advanced classical Hodgkin lymphoma (cHL). Recent data on combining brentuximab vedotin, doxorubicin, vinblastine, and dacarbazine demonstrated improved overall survival compared with ABVD but increased adverse events (AEs). We hypothesized that replacing vinblastine with nivolumab (brentuximab vedotin and nivolumab [AN] + doxorubicin and dacarbazine [AD]; AN+AD) may improve efficacy and safety. This phase 2, open-label multipart, multicenter study enrolled patients with treatment-naive stage II bulky or III/IV cHL. Patients received ≤6 cycles of AN+AD; granulocyte-colony stimulating factor (G-CSF) prophylaxis was optional, per institutional guidelines. At the time of planned analysis (N = 57), complete response (CR) and objective response rates were 88% (95% confidence interval [CI], 76.3-94.9) and 93% (95% CI, 83.0-98.1), respectively. With a median follow-up of 24.2 months (95% CI, 23.4-26.9), the 2-year progression-free survival rate was 88% (95% CI, 75.7-94.6); 88% (95% CI, 75.7-94.6) had a response lasting >2 years. Most common grade ≥3 treatment-related AEs were alanine aminotransferase increased (11%) and neutropenia (9%); 44% had treatment-related peripheral sensory neuropathy (grade 1/2, 40%; grade 3, 4%). No febrile neutropenia occurred; 49% received G-CSF prophylaxis. AN+AD led to a high CR rate and favorable safety profile. Further evaluation of programmed death receptor 1 inhibitor and CD30 antibody–drug conjugate combination regimens in frontline advanced-stage cHL is warranted. This trial was registered at www.clinicaltrials.gov as #NCT03646123 and www.clinicaltrialsregister.eu as #EudraCT 2020-004027-17.

01 Jan 2025·Hematology Transfusion and Cell Therapy

Lower doses of dacarbazine (modified BEACODD) as a safer strategy with equal effectiveness in an intensive treatment protocol of Hodgkin's lymphoma: a preliminary retrospective analysis of a single public center in Brazil

Article

Author: Dulley, Larissa Hilario ; Braga, Arthur Gomes Oliveira ; Rodrigues, Guilherme Garcia ; Chiattone, Carlos Sérgio ; da Silveira, Talita Maira Bueno ; Fortier, Sergio Costa

The German Hodgkin Study Group developed the escalated BEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone) protocol as a treatment strategy for advanced-stage Hodgkin's lymphoma. In Brazil, as well as in other countries, procarbazine has been replaced with dacarbazine due to the limited availability of procarbazine. The Hematology Center at Irmandade da Santa Casa de Misericórdia in São Paulo adopted and modified the escalated BEACOPP protocol, substituting prednisone with dexamethasone and incorporating two different doses of dacarbazine: 375 mg/m²/day on Day 8 or the original dose of 250 mg/m²/day on Days 2 and 3. This adjustment was made in response to the anticipated toxicity profile. This study aimed to compare the two different doses in the protocols (375 mg/m²/cycle versus 500 mg/m²/cycle) administered to patients with advanced Hodgkin's lymphoma in similar periods. This retrospective study analyzed the data of 31 patients at a single center in Brazil from 2019 to 2021. Seventeen of the 31 patients received 500 mg/m²/cycle (500 Group), while 14 received 375 mg/m²/cycle (375 Group). At the end of the protocol, 71% of the patients in the 375 Group and 76% in the 500 Group achieved complete remission. On analyzing the number of cycles that patients presented with febrile neutropenia, the 500 Group had three times more events (17.9%) than the 375 Group (6.09% - p-value = 0.04). In the 500 Group, 47.1% needed to change the protocol to ABVD (doxorubicin hydrochloride, bleomycin sulfate, vinblastine sulfate, and dacarbazine) due to toxicity. In this limited cohort from a single public center in Brazil, the use of 375 mg/m² of dacarbazine per cycle of the modified escalated BEACOPP protocol emerged as a safer strategy, maintaining treatment efficacy without compromising response in patients with advanced Hodgkin's lymphoma.

01 Dec 2024·Hematology Transfusion and Cell Therapy

Benefits of BV-AVD (Brentuximab vedotin, doxorubicin, vinblastine, and dacarbazine) versus ABVD (doxorubicin hydrochloride, bleomycin sulfate, vinblastine sulfate, dacarbazine) in patients with advanced-stage Hodgkin's lymphoma: an analysis of the ECHELON 1 trial by the GATLA group using the Delphi Method

Article

Author: Altuve, Juan Ignacio Garcia ; Pavlovsky, Astrid ; Negri Aranguren, Florencia ; Cerutti, Amalia ; Aranguren, Flor Negri ; Warley, Fernando ; Fiad, Lorena ; Kurgansky, Nicolás

INTRODUCTION:

The BV-AVD (Brentuximab vedotin, doxorubicin, vinblastine, and dacarbazine) combination for first-line treatment of advanced stage Hodgkin's lymphoma has been approved by regulatory authorities and included in international guidelines. However, several factors influence its incorporation as standard of care.

MATERIALS AND METHODS:

A group of experts from different institutions was identified and, using the Delphi method, an analysis of the results of the ECHELON 1 trial for the indication of BV-AVD over ABVD (doxorubicin hydrochloride, bleomycin sulfate, vinblastine sulfate, dacarbazine) in patients with Hodgkin's lymphoma Stages III and IV in Argentina was done. The clinical and academic experience of the authors and the context of the Argentine healthcare system were considered.

RESULTS AND DISCUSSION:

Seven statements on general aspects of the management of Hodgkin's lymphoma and nine on specific aspects related to the use of BV-AVD over ABVD reached a consensus of agreement. There was a strong expert consensus in favor of indicating BV-AVD in the presence of extranodal disease or pulmonary disease. Moderate to severe neuropathy, pregnancy and drug allergy were considered absolute contraindications to prescribe BV.

CONCLUSIONS:

The authors agreed that BV-AVD could be considered a new treatment option in high-risk patients. However health system-dependent factors (such as high cost, lack of availability, reimbursement difficulties, irregular delivery, and issues with granulocyte-colony stimulating factor availability) could pose limitations for this prescription. While awaiting new data from clinical trials and real-world studies, these recommendations can represent a useful tool for hematologists in different parts of the world.

1

News (Medical) associated with Bleomycin Sulfate

29 Oct 2023

·www.pharmaindustrial-india.com

Venus Remedies Granted Market Authorization for Bleomycin 15,000 IU in UK

Venus Remedies announce the achievement of market authorization in the United Kingdom for Bleomycin 15,000 IU Powder for Solution for Injection/Infusion by its German subsidiary, Venus Pharma GmbH. This remarkable milestone not only expands the pharma giant's global presence but also underscores its commitment to advancing cancer care with innovative solutions. Bleomycin 15,000 IU is a potent medication that contains the active ingredient bleomycin sulfate. It belongs to a group of medicines known as cytostatic drugs, specifically designed to combat cancer. This class of medications, often referred to as chemotherapy, is renowned for its effectiveness in targeting cancer cells and preventing their uncontrolled division. Its versatile applications include the treatment of certain types of squamous cell carcinomas in the head and neck, cervix, and external genitalia. It also serves as a panacea in treating severe types of lymph node cancers, such as Hodgkin's disease and non-Hodgkin's lymphoma of intermediate and high malignancy, testicular cancer, and fluid accumulation in the lungs, often associated with cancer. Bleomycin can be administered as a standalone treatment or in combination with other cancer medications and radiotherapy. Its effectiveness and utility in cancer treatment have earned it market authorizations in numerous countries worldwide. Venus Remedies is proud to hold a total of 15 Market Authorizations (MA) for Bleomycin products across the globe. As part of its efforts to make Bleomycin more accessible, the company has submitted sixteen additional applications to Ministries of Health (MOHs) around the world. Venus has secured 15 registrations for this drug across various regions, including Africa, Asia, the Middle East, the Commonwealth of Independent States (CIS), North America, and South America. "At Venus, our mission is to improve the lives of cancer patients by providing cutting-edge treatments. The UK's market authorization for Bleomycin 15,000 IU Powder for Solution for Injection/Infusion is a significant step towards realizing this mission. We remain dedicated to enhancing healthcare solutions and are committed to pursuing additional authorizations to reach even more patients in need," stated Saransh Chaudhary, CEO, Venus Medicine Research Center (VMRC). For Venus Pharma GmbH, the achievement of receiving market authorization from a regulatory agency like the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom is a significant validation of the company's commitment to pharmaceutical excellence. This achievement enhances the company's reputation, not only in the UK but also on the international stage, signifying its competence in delivering pharmaceutical products that can positively impact patient lives. Ashutosh Jain, CEO, Venus Pharma GmbH, expressed that obtaining market authorization from MHRA is a momentous accomplishment for Venus Pharma GmbH. It enables the company to play a pivotal role in advancing cancer care and improving the quality of life for patients facing this challenging disease.

Drug Approval

100 Deals associated with Bleomycin Sulfate

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External Link

KEGG	Wiki	ATC	Drug Bank
D02177	Bleomycin Sulfate	L01DC01	DBSALT000196

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Basal Cell Neoplasms	Japan	Nippon Chemical	04 Aug 1975
Skin Neoplasms	United States	Nippon Kayaku Co., Ltd.	04 Aug 1975
Lymphoma	United States	Bristol Myers Squibb Co.	31 Jul 1973
Malignant Pleural Effusion	United States	Bristol Myers Squibb Co.	31 Jul 1973
Squamous Cell Carcinoma	United States	Bristol Myers Squibb Co.	31 Jul 1973
Testicular Neoplasms	United States	Bristol Myers Squibb Co.	31 Jul 1973

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Head and Neck Neoplasms	Phase 3	United States	Inovio Pharmaceuticals, Inc.	01 Jun 2004
Squamous Cell Carcinoma of Head and Neck	Phase 2	France	PCI Biotech AS	01 Apr 2012
Squamous Cell Carcinoma of Head and Neck	Phase 2	Germany	PCI Biotech AS	01 Apr 2012
Squamous Cell Carcinoma of Head and Neck	Phase 2	Lithuania	PCI Biotech AS	01 Apr 2012
Squamous Cell Carcinoma of Head and Neck	Phase 2	Netherlands	PCI Biotech AS	01 Apr 2012
Squamous Cell Carcinoma of Head and Neck	Phase 2	Poland	PCI Biotech AS	01 Apr 2012
Squamous Cell Carcinoma of Head and Neck	Phase 2	United Kingdom	PCI Biotech AS	01 Apr 2012

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02291133 (ECT-HCC, CTgov)	Phase 1/2	Primary Malignant Liver Neoplasm	25	Cliniporator Vitae®+Bleomycin PHC 15 e. (United States Pharmacopeia - USP)	jzozfdkerk = nmqpqrqovc vvvjlglcnm (fmfeawzbcf, edtwpystyo - vqdxbvunuo) View more	-	23 Jul 2021
NCT01132807 (CTgov)	Phase 2	Non-Hodgkin Lymphoma	164	ABVD (Treatment (ABVD: 4 Cycles))	xjsvmkthjf = aockqvbinm uuljqxhmzz (dpwusxvcnx, bzhfvkpigi - syhancxtkr) View more	-	14 Jun 2021
				BEACOPP (Escalated BEACOPP and Involved Field Radiation Therapy)	tozveioint = nzfiuntgqi hyvndgalhr (obcxlxrecf, mlucgmtfio - gjpluightx) View more
NCT00104676 (GETUG 13, CTgov)	Phase 3	Teratoma \| Nonseminomatous Germ Cell Tumor \| Testicular Germ Cell Tumor	263	etoposide+cisplatin+bleomycin sulfate (Arm I)	csigpvqyvr = vgznirhsyi jtkjmyguys (bcpuyzejhn, sktbfcvtfg - ukxuhswaoe) View more	-	07 Jun 2021
				etoposide+ifosfamide+paclitaxel+cisplatin+oxaliplatin+bleomycin sulfate (Arm II)	csigpvqyvr = niqquwjswt jtkjmyguys (bcpuyzejhn, bbhlhflmsc - hlizkthhil) View more
NCT02352259 (CTgov)	Phase 2	Liver metastases	23	Cliniporator Vitae®+Bleomycin PHC 15 e. (United States Pharmacopeia - USP)	ugnasnicez = btgycfnhqh lstyivvrtx (dledvojemq, hfracrbsli - qsutbhcvrr) View more	-	24 Mar 2021
NCT00025259 (AHOD0031, CTgov)	Phase 3	Hodgkin's Lymphoma \| Childhood Nodular Sclerosis Classic Hodgkin Lymphoma	1,734	Etoposide+cyclophosphamide+Prednisone+Filgrastim+Doxorubicin Hydrochloride+Vincristine Sulfate Liposome+Bleomycin Sulfate (Arm I (Patients Off-therapy Before Callback-Induction Only))	rochogbejr = pmgcgxekgp tlbjqiobvz (ywzuruekkf, btmlpaaopl - sdbhftraai) View more	-	07 Mar 2017
				Involved-Field Radiation Therapy+Etoposide+cyclophosphamide+Prednisone+Filgrastim+Doxorubicin Hydrochloride+Vincristine Sulfate Liposome+Bleomycin Sulfate (Arm II (RER With CR [ABVE-PC, IFRT]))	rochogbejr = ymygdoymwy tlbjqiobvz (ywzuruekkf, wkalcluhaf - fzsufpgdnl) View more