FGFR1 antagonists(Fibroblast growth factor receptor 1 antagonists), FGFR3 antagonists(Fibroblast growth factor receptor 3 antagonists), Flt3L stimulants(Fms-related tyrosine kinase 3 ligand stimulants)

Therapeutic Areas

NeoplasmsUrogenital DiseasesOther Diseases

Active Indication

Renal Cell CarcinomaSarcomaAdvanced Renal Cell Carcinoma+ [3]

Inactive Indication

Adenocarcinoma of prostateAdvanced Bile Duct CarcinomaAdvanced breast cancer+ [120]

Originator Organization

GSK Plc

Active Organization

Novartis Europharm Ltd.

Novartis Pharmaceuticals Corp.

Novartis AG

+ [2]

Inactive Organization

National Cancer Institute

Memorial Sloan Kettering Cancer Center

Glaxo Group Ltd.

+ [3]

Drug Highest PhaseApproved

First Approval Date

US (19 Oct 2009),

Advanced Renal Cell Carcinoma

RegulationOrphan Drug (US)

Structure

Molecular FormulaC21H24ClN7O2S

InChIKeyMQHIQUBXFFAOMK-UHFFFAOYSA-N

CAS Registry635702-64-6

375

Clinical Trials associated with Pazopanib Hydrochloride

NCT04199026 / Not yet recruitingEarly Phase 1IIT

Pilot Trial of an Implantable Microdevice for In Vivo Drug Sensitivity Testing in Patients With Sarcomas

This early phase I trial studies the side effects of implanting and removing a microdevice in patients with sarcomas that have spread to other places in the body (metastatic) or have come back (recurrent). Microdevices are rice-sized devices that are implanted into tumor tissue and are loaded with 10 different drugs that are delivered at very small doses, or "microdoses," which may only affect a very small, local area inside the tumor. The purpose of this study is to determine which drugs delivered in the microdevice affect tumor tissue in patients with sarcomas.

Start Date31 Jan 2025

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

[+1]

NCT05949424 / Not yet recruitingPhase 4IIT

Optimal Dosing of Oral Anticancer Drugs in Older Adults With Cancer: a Randomized Pilot Study.

The study hypothesis is that a lower starting dose of anticancer tablet treatments can lead to better treatment tolerability in older patients, while the benefits of treatment can be the same. The trial population consists of 30 patients aged 65 years or older, who are starting treatment with one of these anti cancer tablet treatments: pazopanib, olaparib, lenvatinib, sunitinib or palbociclib. The control group (half of the participants) will be treated with the standard-of-care, the interventional group will start with the lowest dose of the anti cancer tablets as described in the drug label. The dose will be increased every two weeks in case of good tolerability. Results of this pilot study will be used to inform the design of the larger randomised phase 2 trial.

Start Date01 May 2024

Sponsor / Collaborator

University Medical Center Groningen

NCT06239272 / RecruitingPhase 1/2IIT

NRSTS2021, A Risk Adapted Study Evaluating Maintenance Pazopanib, Limited Margin, Dose-Escalated Radiation Therapy and Selinexor in Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS)

The study participant has been diagnosed with non-rhabdomyosarcoma (NRSTS).
Primary Objectives
Intermediate-Risk
To estimate the 3-year event-free survival for intermediate-risk patients treated with ifosfamide, doxorubicin, pazopanib, surgery, and maintenance pazopanib, with or without RT.
To characterize the pharmacokinetics of pazopanib and doxorubicin in combination with ifosfamide in intermediate-risk participants, to assess potential covariates to explain the inter- and intra-individual pharmacokinetic variability, and to explore associations between clinical effects and pazopanib and doxorubicin pharmacokinetics.
High-Risk
To estimate the maximum tolerated dose (MTD) and/or the recommended phase 2 dosage (RP2D) of selinexor in combination with ifosfamide, doxorubicin, pazopanib, and maintenance pazopanib in high-risk participants.
To characterize the pharmacokinetics of selinexor, pazopanib and doxorubicin in combination with ifosfamide in high-risk participants, to assess potential covariates to explain the inter- and intra-individual pharmacokinetic variability, and to explore associations between clinical effects and selinexor, pazopanib and doxorubicin pharmacokinetics.
Secondary Objectives
To estimate the cumulative incidence of primary site local failure and distant metastasis-free, disease-free, event-free, and overall survival in participants treated on the risk-based treatment strategy defined in this protocol.
To define and describe the CTCAE Grade 3 or higher toxicities, and specific grade 1-2 toxicities, in low- and intermediate-risk participants.
To study the association between radiation dosimetry in participants receiving radiation therapy and the incidence and type of dosimetric local failure, normal adjacent tissue exposure, and musculoskeletal toxicity.
To evaluate the objective response rate (complete and partial response) after 3 cycles for high-risk patients receiving the combination of selinexor with ifosfamide, doxorubicin, pazopanib, and maintenance pazopanib.
To assess the relationship between the pharmacogenetic variation in drug-metabolizing enzymes or drug transporters and the pharmacokinetics of selinexor, pazopanib, and doxorubicin in intermediate- or high-risk patients.
Exploratory Objectives
To explore the correlation between radiographic response, pathologic response, survival, and toxicity, and tumor molecular characteristics, as assessed through next-generation sequencing (NGS), including whole genome sequencing (WGS), whole exome sequencing (WES), and RNA sequencing (RNAseq).
To explore the feasibility of determining DNA mutational signatures and homologous repair deficiency status in primary tumor samples and to explore the correlation between these molecular findings and the radiographic response, survival, and toxicity of patients treated on this protocol.
To explore the feasibility of obtaining DNA methylation profiling on pretreatment, post-induction chemotherapy, and recurrent (if possible) tumor material, and to assess the correlation with this and pathologic diagnosis, tumor control, and survival outcomes where feasible.
To explore the feasibility of obtaining high resolution single-cell RNA sequencing of pretreatment, post-induction chemotherapy, and recurrent (if possible) tumor material, and to characterize the longitudinal changes in tumor heterogeneity and tumor microenvironment.
To explore the feasibility of identifying characteristic alterations in non-rhabdomyosarcoma soft tissue sarcoma in cell-free DNA (cfDNA) in blood as a non-invasive method of detecting and tracking changes during therapy, and to assess the correlation of cfDNA and mutations in tumor samples.
To describe cardiovascular and musculoskeletal health, cardiopulmonary fitness among children and young adults with NRSTS treated on this protocol.
To investigate the potential prognostic value of serum cardiac biomarkers (high-sensitivity cardiac troponin I (hs-cTnI), N-terminal pro B-type natriuretic peptide (NT-Pro-BNP), serial electrocardiograms (EKGs), and serial echocardiograms in patients receiving ifosfamide, doxorubicin, and pazopanib, with or without selinexor.
To define the rates of near-complete pathologic response (>90% necrosis) and change in FDG PET maximum standard uptake value (SUVmax) from baseline to week 13 in intermediate risk patients with initially unresectable tumors treated with induction pazopanib, ifosfamide, and doxorubicin, and to correlate this change with tumor control and survival outcomes.
To determine the number of high-risk patients initially judged unresectable at diagnosis that are able to undergo primary tumor resection after treatment with ifosfamide, doxorubicin, selinexor, and pazopanib.
To identify the frequency with which assessment of volumes of interest (VOIs) of target lesions would alter RECIST response assessment compared with standard linear measurements.

Start Date27 Mar 2024

Sponsor / Collaborator

St. Jude Children's Research Hospital, Inc.

100 Clinical Results associated with Pazopanib Hydrochloride

100 Translational Medicine associated with Pazopanib Hydrochloride

100 Patents (Medical) associated with Pazopanib Hydrochloride

2,150

Literatures (Medical) associated with Pazopanib Hydrochloride

01 Feb 2024·Cancer Chemotherapy and Pharmacology

Pazopanib pharmacokinetically guided dose optimization in three cancer patients with gastrointestinal resection

Article

Author: Alexandre, Jérôme ; Tardy, Cléa ; Berge, Marion ; Ulmann, Guillaume ; Blanchet, Benoit ; Puszkiel, Alicja ; Batista, Rui ; Thomas Schoemann, Audrey ; Goldwasser, Francois ; Boudou-Rouquette, Pascaline ; De Percin, Sixtine

PURPOSE:

Pazopanib is approved in advanced renal cell carcinoma (RCC) and soft-tissue sarcoma at a flat-fixed dose despite a large pharmacokinetics interindividual variability and a narrow therapeutic index. To our knowledge, pazopanib exposure in patients with gastrointestinal resections (GIR) has not been described. This report focuses on feasibility of pharmacokinetics-guided dose escalation in these patients and clinical implications for their management.

METHOD:

A retrospective data collection was performed for three patients with GIR treated with pazopanib, including pazopanib plasma concentrations (high-performance liquid chromatography with UV detection) and treatment adherence (Girerd score).

CASE PRESENTATION:

First patient (55-year-old man, RCC, gastric bypass surgery) pazopanib C_min,ss at day 39 was 4.1 mg/L. Dose escalation to 1800 mg/day fractionated allowed to reach C_min,ss of 18.5 mg/L (target threshold in RCC patients: 20.5 mg/L). Patient 2 (50-year-old woman, metastatic myxofibrosarcoma, gastric band) showed C_min,ss of 4.0 mg/L at day 13. In patient 3 (49-year-old man, gastric malignant peripheral nerve sheath tumor, gastrectomy), C_min,ss at day 13 was 2.7 mg/L. For these two patients, intake with food and dose fractioning only slightly increased pazopanib C_min,ss to 12.0 mg/L and 6.5 mg/L, respectively (therapeutic threshold in sarcoma patients: 27 mg/L). Treatment adherence was good in all patients.

CONCLUSION:

Optimal pazopanib exposure cannot be achieved in patients with GIR, and thus, other therapeutic strategies should be encouraged. Pretherapeutic assessment seems crucial to evaluate factors as bariatric surgery that may impact pazopanib concentrations. Therapeutic drug monitoring could be helpful to optimize pazopanib response in these patients.

01 Feb 2024·Cancer Chemotherapy and Pharmacology

Are novel oral oncolytics underdosed in obese patients?

Article

Author: van der Meer, Ellen K O ; Beijnen, Jos H ; Huitema, Alwin D R ; Lin, Lishi ; Steeghs, Neeltje

Abstract:

Purpose:

Data on the effects of obesity on drug exposure of oral targeted oncolytics is scarce. Therefore, the aim of this study was to investigate the influence of body weight and body mass index (BMI) on trough levels of oral oncolytics with an exposure–response relationship. The oral oncolytics of interest were abiraterone, alectinib, cabozantinib, crizotinib, imatinib, pazopanib, sunitinib and trametinib.

Methods:

This retrospective cohort study included patients treated with the selected oral oncolytics at the standard dose, with a measured trough level at steady state and with available body weight. The Spearman’s correlation test was used to determine the correlation between body weight and trough levels. The Fisher’s exact text was used to compare the frequency of inadequate trough levels between BMI categories.

Results:

1265 patients were included across the different oral oncolytics. A negative correlation coefficient was observed between weight and trough levels for crizotinib (n = 75), imatinib (n = 201) and trametinib (n = 310), respectively, ρ = − 0.41, ρ = − 0.24 and ρ = − 0.23, all with a p-value < 0.001. For crizotinib, a higher percentage of patients with a body weight > 100 kg had inadequate trough levels. No statistically significant differences were observed in the frequency of inadequate trough levels between BMI categories.

Conclusion:

Higher body weight was only correlated with lower plasma trough levels for crizotinib, imatinib, and trametinib. Therefore, patients with a high body weight may require dose escalation to obtain adequate target levels when treated with these oral oncolytics.

25 Jan 2024·Circulation journal : official journal of the Japanese Circulation SocietyQ3 · MEDICINE

Assessment of Pazopanib-Related Heart Failure in Patients With Advanced Soft Tissue Sarcoma　― A Single Institute Analysis ―

Q3 · MEDICINE

Article

Author: Yunokawa, Mayu ; Fukuda, Naoki ; Nishizawa, Masatoshi ; Oyakawa, Takuya ; Ebihara, Aya ; Nakano, Kenji ; Takahashi, Shunji ; Wang, Xiaofei ; Urasaki, Tsuya ; Shiga, Taro ; Tomomatsu, Junichi ; Ono, Makiko ; Ohmoto, Akihiro ; Sato, Yasuyoshi

BACKGROUND:

Heart failure (HF) is one of the potential adverse events of pazopanib treatment for soft tissue sarcoma (STS), but detailed reports of such HF cases are scarce. This study determined the incidence and risk factors of HF following pazopanib treatment for STS at our Institute and the clinical outcomes.Methods and Results:This study retrospectively analyzed the cases of STS patients treated with pazopanib (n=151) between 2012 and 2020. HF occurred in 6 patients (3.9%) at the median onset of 137 (range 14-468) days after the treatment initiation. When their HF was diagnosed, pazopanib was interrupted in all 6 patients. No patients experienced HF-related death, and HF development was not a significant factor for poor overall survival. The cumulative doses of anthracyclines (>225 mg/m²) before pazopanib initiation (83% vs. 37%, P=0.031), pazopanib initiation at age ≥60 years (83% vs. 35%, P=0.026), and the baseline B-type natriuretic peptide (BNP) concentration (≥50 pg/mL) before pazopanib (67% vs. 11%, P=0.002) initiation were predictive factors for post-pazopanib treatment HF.

CONCLUSIONS:

The study findings highlight the effect of past anthracycline exposure and baseline BNP for pazopanib-associated HF. Although the study patients' clinical outcomes were generally favorable, periodic monitoring of cardiac function using ultrasonic echocardiography or serum markers is essential to detect events early and begin therapeutic intervention appropriately under a cardiologist's instructions.

News (Medical) associated with Pazopanib Hydrochloride

03 Nov 2023

·www.biospace.com

Sonata Therapeutics Presents Data Supporting its Network Medicines™ Approach at SITC 2023

- Data showcase efficacy of Sonata’s SNT-3010912, SNT-20109 and SNT-101 programs in tumor models, demonstrating broad potential of Network Medicines to modulate all key cell types in tumor microenvironment - WATERTOWN, Mass.--(BUSINESS WIRE)-- Sonata Therapeutics, Inc., a biotechnology company developing a new class of therapeutics called Network Medicines™, will present three posters at the Society for Immunotherapy of Cancer (SITC) Annual Meeting. The posters highlight Sonata’s proprietary Intrinsic Antigen Release Technology (iART) and two of the company’s oncology programs, all of which demonstrated in vivo efficacy in a variety of tumor models. Network Medicines are drugs designed to modulate all the key cell types in networks of multifactorial diseases, thereby to halt or potentially reverse damage caused by such diseases. The majority of medicines are designed to disrupt or enhance single pathways in order to stop disease progression, but this approach often requires additional medications that target a different pathway, or combination therapy, to prevent drug resistance or drive response. In contrast, Sonata’s Network Medicines target pathways that change the complete dynamics of multifactorial diseases, resulting in more durable therapeutics and potentially better outcomes for patients. Poster presentation details: Title: Sonata’s Proprietary Intrinsic Antigen Release Technology (iART) Drives In Situ Generation of Potent Anti-Tumor Immunity Across Warm and Cold Tumor Models Date/Time: Friday, November 3, 2023, 12:00pm-1:30pm and 5:10pm-6:40pm PT Abstract Number: 1403-B Key takeaways: Highlights the efficacy of SNT-3010912, Sonata’s proprietary iART, delivered as an mRNA payload across both warm and cold tumor models. Delivered intratumorally, SNT-3010912 induced a state-of-the-art form of enhanced immunogenic antigen release. Demonstrated durable in vivo efficacy in both models, with nearly complete tumor growth inhibition and >80% complete response when delivered to warm tumor models and prolonged tumor growth inhibition in the majority of cold tumor models. Efficacy across a variety of tumor models highlights the distinctive capacity of Sonata’s iART to drive protective immunity across a spectrum of tumor immune landscapes. Title: SNT-20109 Induces Protective Immunity in the Murine Syngeneic Tumor Cell Line, CT26: A Dual Approach of Direct Cytotoxicity and Defined Immune Activation Date/Time: Friday, November 3, 2023, 12:00pm-1:30pm and 5:10pm-6:40pm PT Abstract Number: 1387 Key takeaways: Highlights the use of SNT-20109, one of Sonata’s lead oncology programs, in an engineered murine tumor model. Demonstrated durable in vivo efficacy, inducing an innovative form of enhanced immunogenic cell death (ICD) that has never been characterized and robust production of pro-inflammatory cytokines and chemokines with known antitumoral effects not typically seen following ICD. Mice treated with SNT-20109 showed significant tumor growth inhibition, and nine of the ten subjects showed complete regression, indicating it could drive a unique immunological cascade with broad potential for future cancer treatment investigations. Title: Exploring Novel Ferroptosis Inducer as a Promising Strategy for Sarcoma Treatment Date/Time: Saturday, November 4, 2023, 11:55am-1:25pm and 7:00pm-8:30pm PT Abstract Number: 1442 Key takeaways: Highlights the use of SNT-101 as a novel ferroptosis inducer for the potential treatment of sarcomas in human and murine cell lines. SNT-101 potently reduced viability, and induced cell death and lipid peroxidation in both cell lines, resulting in significant target exposure and tumor growth inhibition. Efficacy was benchmarked against pazopanib, showing that SNT-101 had improved efficacy compared to pazopanib. Data demonstrate that ferroptosis induction is a promising strategy for the treatment of sarcomas, supporting Sonata’s continued investigation in syngeneic mouse models. “Sonata’s poster presentations showcase exciting early data for our Network Medicines, highlighting how this new therapeutic class could dramatically improve outcomes in the field of immuno-oncology,” said Volker Herrmann, M.D., MBA, Chief Executive Officer and President of Sonata Therapeutics. “Through our proprietary platform, Sonata is generating Network Medicines that move beyond the current immunotherapeutic paradigm. While current therapeutics are typically designed to address only one or two pathways, Network Medicines are intentionally designed to modulate all key pathways that drive disease.” The first two posters will be presented by Ryan Shaler, Ph.D., in Exhibit Halls A and B1 of the San Diego Convention Center on Friday, November 3. The third poster will be presented by Maria Cristina Munteanu, Ph.D., on the Ground Level of Exhibit Hall B in the San Diego Convention Center on Saturday, November 4. More information on the presentations can be found at the SITC website. Satellite Symposium Sonata’s Chief Scientific Officer Francesco Marincola, M.D., will also co-chair a SITC satellite symposium, “Synthetic Biology – Cell Therapy for Patients with Solid Cancer,” on Friday, November 3 from 12:15-1:15 pm PT in Room 11AB of the conference venue. The symposium, sponsored by the Champalimaud Foundation, will highlight real-world challenges, outline solutions and foster collaborations to achieve the ultimate goal of significantly improving the survival of patients with cancer through synthetic biology. About Sonata Therapeutics Sonata Therapeutics is creating a new class of Network Medicines™ designed to modulate all the key cell types in a disease microenvironment required to drive disease resolution. We are building a diverse portfolio of promising medicines for oncology and exploring additional therapeutic areas such as fibrosis and tissue regeneration where multicellular networks play a key role.

ImmunotherapyClinical ResultCell TherapyClinical Study

02 Oct 2023

·www.biospace.com

Boundless Bio Appoints New Board Members and Establishes Clinical Advisory Board

James Christensen, Ph.D., and Nancy Whiting, Pharm.D., join Board of Directors George Demetri, M.D., to serve as first member of Clinical Advisory Board SAN DIEGO--(BUSINESS WIRE)-- Boundless Bio, a clinical stage, next-generation precision oncology company interrogating extrachromosomal DNA (ecDNA) biology to deliver transformative therapies to patients with previously intractable oncogene amplified cancers, today announced the appointment of two new members to its Board of Directors and the establishment of its Clinical Advisory Board. Industry veterans James (“Jamie”) Christensen, Ph.D., Chief Scientific Officer of Mirati Therapeutics, and Nancy Whiting, Pharm.D., Chief Executive Officer of Recludix Pharma, will join Boundless Bio’s Board of Directors. George Demetri, M.D., Director of the Sarcoma Center at the Dana-Farber Cancer Institute, will serve as the first member of the company’s Clinical Advisory Board. “We are thrilled to welcome these highly accomplished professionals who bring deep oncology drug development experience to Boundless Bio,” said Zachary Hornby, President and Chief Executive Officer of Boundless Bio. “Jamie and Nancy are incredibly valuable additions to our Board of Directors, having each led the discovery, development, and regulatory approvals of multiple approved cancer medicines. George is a world-renowned leader in the clinical translation of innovative treatment strategies for cancer, and his appointment establishes our Clinical Advisory Board. Together, their involvement and experience will prove invaluable as we continue to advance the Phase 1/2 clinical trial of BBI-355, progress additional ecDNA-directed therapeutic candidates (ecDTx) into the clinic, and initiate drug discovery programs arising from our Spyglass platform for identifying novel ecDNA targets." Appointment of Jamie Christensen, Ph.D., and Nancy Whiting, Pharm.D., to Board of Directors Dr. Jamie Christensen has served as the Chief Scientific Officer of Mirati Therapeutics, a publicly traded precision oncology company, since 2013 and is responsible for drug discovery, translational research, drug manufacturing, and companion diagnostics research. At Mirati, Dr. Christensen leads activities related to the discovery and advancement of the company’s clinical and preclinical programs, including Mirati’s first approved product, Krazati®(adagrasib). Prior to Mirati, Dr. Christensen was the Head of Oncology Precision Medicine and a member of the executive leadership team in the Oncology Research Unit at Pfizer. He joined Pfizer in 2003, where his responsibilities included leading oncology nonclinical research and translational sciences for programs including Sutent® (sunitinib malate) and Xalkori® (crizotinib). Prior to Pfizer, Dr. Christensen held positions at SUGEN/Pharmacia as a group leader in preclinical research and exploratory development. He began his career in the pharmaceutical industry at Warner Lambert/Parke-Davis. Dr. Christensen has authored or co-authored over 150 peer-reviewed research articles in scientific journals including Science, Nature, Cancer Cell, Cancer Discovery, New England Journal of Medicine, and many others. He received his Ph.D. at North Carolina State University and his B.S. in biology from Northern Illinois University. Dr. Nancy Whiting is the Chief Executive Officer of Recludix Pharma, a private company developing novel treatments for inflammatory disease and cancer, and has an established track record in all phases of oncology drug development. Prior to Recludix, Dr. Whiting was a 15-year veteran of Seagen where she served most recently as Executive Vice President of Corporate Strategy, Alliances, and Communication. Prior to this role at Seagen, Dr. Whiting served as Executive Vice President of Development, Senior Vice President of Clinical Development and Medical Affairs, and Head of Experimental Medicine. During her tenure at Seagen, Dr. Whiting played a central role in the development and regulatory approvals of cancer medicines Adcetris® (brentuximab vedotin), Padcev® (enfortumab vedotin-ejfv), Tukysa® (tucatinib) and Tivdak® (tisotumab vedotin). Prior to her career in the pharmaceutical industry, Dr. Whiting practiced as a clinical oncology pharmacist at the Seattle Cancer Care Alliance. Dr. Whiting serves on the Board of Directors of Caribou Biosciences. She received her Pharm.D. from the University of Washington and completed her undergraduate degree at the University of British Columbia. Appointment of George Demetri, M.D., to Clinical Advisory Board Dr. George Demetri currently serves as the Quick Family Chair in Medical Oncology and Director of the Sarcoma Center at Dana-Farber Cancer Institute, as well as Professor of Medicine at Harvard Medical School and Co-Director of the Ludwig Center at Harvard. He has dedicated his career to translational and clinical research aimed at developing clinical therapeutics from scientific mechanisms to treat life-threatening cancers. Dr. Demetri is a pioneer in the development of multiple targeted cancer therapies, and research from his collaborative efforts has resulted in FDA and worldwide regulatory approvals of several cancer therapies, including Gleevec® (imatinib), Sutent® (sunitinib), Stivarga® (regorafenib), Votrient® (pazopanib), Yondelis® (trabectedin), and Tazverik® (tazemetostat). Dr. Demetri received his undergraduate degree in biochemistry from Harvard College and M.D. from Stanford University School of Medicine, after which he completed his internal medicine residency and chief residency at the University of Washington Hospitals in Seattle and subsequently trained in medical oncology at the Dana-Farber Cancer Institute and Harvard Medical School. He is also a member of the Science Policy and Government Affairs Committee of the American Association for Cancer Research, for which he served as the immediate past chair. About Boundless Bio Boundless Bio is a clinical-stage precision oncology company dedicated to unlocking a new paradigm in cancer therapeutics to address the significant unmet need in patients with oncogene amplified tumors by targeting extrachromosomal DNA (ecDNA), a root cause of oncogene amplification observed in more than 14% of cancer patients. Boundless Bio is developing the first ecDNA-directed therapy (ecDTx), BBI-355, which is being evaluated in a Phase 1/2 clinical trial, and has multiple other pipeline programs advancing in preclinical development and discovery. To date, Boundless Bio has raised more than $250 million from leading life sciences investors. For more information, visit . Follow us on LinkedIn and Twitter.

Executive ChangeClinical Study

30 Aug 2023

·www.pharmaceutical-technology.com

FDA grants priority review for Zealand Pharma’s dasiglucagon

Dasiglucagon is intended for usage in infants aged seven days and above with congenital hyperinsulinism. Credit: Liudmila Fadzeyeva / Shutterstock.com. The US Food and Drug Administration (FDA) has granted priority review for Zealand Pharma ’s dasiglucagon for hypoglycemia prevention and treatment in the paediatric population with congenital hyperinsulinism (CHI), a rare genetic ailment. Dasiglucagon is intended for usage in infants aged seven days and above, dosing for up to three weeks. Recommended Reports Reports LOA and PTSR Model - Aminolevulinic Acid Hydrochloride in Cervical Intraepithelial Neoplasia (CIN) GlobalData Reports LOA and PTSR Model - Pazopanib Hydrochloride in Gliosarcoma GlobalData View all Companies Intelligence Zealand Pharma AS CGM SpA View all A decision on the approval from the regulatory agency is anticipated on 30 December 2023. The regulator will carry out the review in two stages under one new drug application (NDA) to guarantee the best regulatory approach. Part one is linked to dosing with dasiglucagon for up to three weeks while part two is linked to the product’s usage beyond that time. To assess the usage of dasiglucagon for the disease beyond three weeks, the regulator sought further assessments from existing continuous glucose monitoring datasets. Zealand Pharma is expected to make the submission before the end of 2023. The Prescription Drug User Fee Act (PDUFA) date for the second part will be decided after filing data from further analyses of existing datasets sought by the FDA. The company chose CGM as a secondary outcome measure in Phase III clinical trials of dasiglucagon. Zealand Pharma chief medical officer David Kendall stated: “We believe that the decision of the FDA to provide such a fast review cycle for the first part of the NDA is a strong testament to the potential value of this product to patients. “We remain in close dialogue with the FDA and appreciate the collaborative nature of our work with the agency, recommending a review of the NDA in two parts under the same application to ensure patient access as fast as possible. “We look forward to continued dialogue with the FDA in generating additional analyses from existing datasets around the use of CGM to be submitted before the end of the year for part two of the NDA review.”

NDAPriority ReviewPhase 3

100 Deals associated with Pazopanib Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D05380	Pazopanib Hydrochloride	L01XE11	DB06589

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Renal Cell Carcinoma	EU	Novartis Europharm Ltd.	14 Jun 2010
Renal Cell Carcinoma	IS	Novartis Europharm Ltd.	14 Jun 2010
Renal Cell Carcinoma	LI	Novartis Europharm Ltd.	14 Jun 2010
Renal Cell Carcinoma	NO	Novartis Europharm Ltd.	14 Jun 2010
Sarcoma	EU	Novartis Europharm Ltd.	14 Jun 2010
Sarcoma	IS	Novartis Europharm Ltd.	14 Jun 2010
Sarcoma	LI	Novartis Europharm Ltd.	14 Jun 2010
Sarcoma	NO	Novartis Europharm Ltd.	14 Jun 2010
Advanced Renal Cell Carcinoma	US	Novartis Pharmaceuticals Corp.	19 Oct 2009

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Soft Tissue Sarcoma	Phase 3	US	GSK Plc	01 Oct 2008
Soft Tissue Sarcoma	Phase 3	JP	GSK Plc	01 Oct 2008
Soft Tissue Sarcoma	Phase 3	AU	GSK Plc	01 Oct 2008
Soft Tissue Sarcoma	Phase 3	BE	GSK Plc	01 Oct 2008
Soft Tissue Sarcoma	Phase 3	DK	GSK Plc	01 Oct 2008
Soft Tissue Sarcoma	Phase 3	FR	GSK Plc	01 Oct 2008
Soft Tissue Sarcoma	Phase 3	DE	GSK Plc	01 Oct 2008
Soft Tissue Sarcoma	Phase 3	IT	GSK Plc	01 Oct 2008
Soft Tissue Sarcoma	Phase 3	NL	GSK Plc	01 Oct 2008
Soft Tissue Sarcoma	Phase 3	KR	GSK Plc	01 Oct 2008

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01575548 (ECOG-ACRIN E2810, Pubmed)	Phase 3	Metastatic Renal Cell Carcinoma	129	Pazopanib 800 mg	zrrcjlcwol(jrivcyqljt) = oxvcycuwlj gigruvdrui (afinilanhl, 17.9 - 41.7) View more	Negative	26 Mar 2024
NCT01575548 (ECOG-ACRIN E2810, Pubmed)	Phase 3	Metastatic Renal Cell Carcinoma	129	Placebo	zrrcjlcwol(jrivcyqljt) = wqdkqskdlw gigruvdrui (afinilanhl, 13.3 - 36.2) View more	Negative	26 Mar 2024
NCT02331498 (PAZOGLIO, ESMO_TAT2024) Manual	Phase 1/2	Glioblastoma Multiforme First line	20	Pazopanib+temozolomide	qxbpaojczo(upexskxmtp) = vbqmiehuqq jkpudztrzo (grjwzchcdt, 52 - 96) View more	Positive	26 Feb 2024
ESC2023	Not Applicable	Renal Cell Carcinoma	-	Patients with RCC treated with sunitinib or pazopanib	btlsymioqg(wnmxfcihsi) = zllnhkjvog agokfxqkjx (zbgidebosx ) View more	-	25 Aug 2023
ASCO2023	Not Applicable	Childhood Rhabdomyosarcoma First line \| Second line \| Maintenance	25	Pazopanib	nwyvrmofvx(anlthxodbe) = qzlultaexd ifbextkdxm (kzvpuuuhru )	Positive	31 May 2023
ASCO2023	Not Applicable	Differentiated Thyroid Gland Carcinoma First line	9	Lenvatinib	osvostngaf(dfypwyxjfv) = nvlsikvqgv iyqycbtsrn (vfimxarxkj ) View more	Positive	31 May 2023
ASCO2023	Not Applicable	Differentiated Thyroid Gland Carcinoma First line	9	Pazopanib	osvostngaf(dfypwyxjfv) = plvwronlih iyqycbtsrn (vfimxarxkj ) View more	Positive	31 May 2023
NCT02331498 (Pazoglio, ASCO2023) Manual	Phase 1/2	Glioblastoma First line	20	Temozolomide+Pazopanib	plwgjpjjln(bmcxwaowqn) = cdzbzmajkb uirjflifrc (nunshztsjf ) View more	Positive	26 May 2023
NCT03798106 (AACR2023) Manual	Phase 2	Sarcoma	46	durvalumab+azopanib	nioduqwqsl(yonsxmkauo) = njowjgkksn okfnqmduyq (fppziyhhdp, 5.7 - 10.4) View more	Positive	14 Apr 2023
NCT01600573 (TOPAZ, Pubmed)	Phase 1/2	Recurrent Platinum-Resistant Ovarian Carcinoma	-	Pazopanib	jkmwqeedsz(xunrtbrcdx) = nrgiuhgmex gfyspvcmzj (bxjaunoflw )	Positive	31 Mar 2023
ESMO_SRC2023	Not Applicable	Ichthyosis, X-Linked	-	Pazopanib	pwrohvcglv(bddrfshmyu) = zerjokpkqv ecoybkjzjh (gqmsuevrag ) View more	-	21 Mar 2023
NCT03200717 (CTgov)	Phase 2	Metastatic Renal Cell Carcinoma \| Advanced Renal Cell Carcinoma	62	Pazopanib (Pazopanib- 2nd Line)	jkofdlypad(ucgtzjdeah) = lnhhieajcm ywyyrowrhr (srilfclhge, dxhoakwcxv - baoycamtck) View more	-	21 Mar 2023
NCT03200717 (CTgov)	Phase 2		62	Pazopanib (Pazopanib- 3rd Line)	jkofdlypad(ucgtzjdeah) = tmgaarojop ywyyrowrhr (srilfclhge, ifgdggmbjg - nfhdqmumsn) View more	-	21 Mar 2023

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