Pancreatic neuroendocrine tumor

FDA Accepts for Priority Review Merck’s Supplemental New Drug Application for WELIREG® (belzutifan) in Certain Previously Treated Patients With Advanced Renal Cell Carcinoma (RCC)

Retrieved on: 
Tuesday, September 19, 2023
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, MSD, Progression-free survival, RCC, Everolimus, MRK, Head, PFS, Merck & Co., Shanda, VHL, Patient, Pancreatic neuroendocrine tumor, PDUFA, Data monitoring committee, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, NYSE, ORR, Food, Pharmaceutical industry, Merck

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a supplemental new drug application (sNDA) seeking approval for WELIREG, Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult patients with advanced renal cell carcinoma (RCC) following immune checkpoint and anti-angiogenic therapies.

Key Points: 
  • Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a supplemental new drug application (sNDA) seeking approval for WELIREG, Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult patients with advanced renal cell carcinoma (RCC) following immune checkpoint and anti-angiogenic therapies.
  • The sNDA is based on data from the LITESPARK-005 trial, in which WELIREG demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to everolimus based on a pre-specified interim analysis conducted by an independent Data Monitoring Committee.
  • A statistically significant improvement in the trial’s key secondary endpoint of objective response rate (ORR) was also demonstrated.
  • The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of January 17, 2024.

Exelixis Announces Positive Results from Phase 3 CABINET Pivotal Trial Evaluating Cabozantinib in Advanced Pancreatic and Extra-Pancreatic Neuroendocrine Tumors

Retrieved on: 
Thursday, August 24, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Glomus tumor, Medical Affairs Bureau, Disease, Senior, DSMB, Safety, Pnet, Alliance for Clinical Trials in Oncology, Incidence, National Cancer Institute, Data monitoring committee, HIV disease progression rates, Patient, Data, Pancreatic neuroendocrine tumor, Cancer, FDA, Exelixis, NCI, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Death, News, Food, EXEL, Dana–Farber Cancer Institute, Pharmaceutical industry, Carcinoid

CABINET is evaluating cabozantinib (CABOMETYX®) compared with placebo in patients with either advanced pancreatic neuroendocrine tumors (pNET) or advanced extra-pancreatic neuroendocrine tumors (also referred to as carcinoid tumors) who experienced progression after prior systemic therapy.

Key Points: 
  • CABINET is evaluating cabozantinib (CABOMETYX®) compared with placebo in patients with either advanced pancreatic neuroendocrine tumors (pNET) or advanced extra-pancreatic neuroendocrine tumors (also referred to as carcinoid tumors) who experienced progression after prior systemic therapy.
  • Cabozantinib substantially prolonged the time without disease progression or death in both of the trial’s cohorts.
  • CABINET is sponsored by the National Cancer Institute (NCI) and is led by The Alliance for Clinical Trials in Oncology.
  • “These promising findings from the CABINET trial, in which cabozantinib showed an efficacy benefit for patients with pancreatic and extra-pancreatic neuroendocrine tumors, are welcome news and show the potential for cabozantinib to address important unmet needs for this community.”

Merck Announces WELIREG® (belzutifan) Phase 3 LITESPARK-005 Trial Met Primary Endpoint of Progression-Free Survival in Certain Previously Treated Patients With Advanced Renal Cell Carcinoma

Retrieved on: 
Friday, August 18, 2023
Biotechnology, General Health, Health, Pharmaceutical, Clinical Trials, MSD, Progression-free survival, RCC, DOR, Everolimus, OS, MRK, Head, PFS, Merck & Co., HIV disease progression rates, VHL, Patient, Risk, Pancreatic neuroendocrine tumor, Data monitoring committee, Death, NYSE, ORR, Pharmaceutical industry, Merck

LITESPARK-005 is evaluating WELIREG for the treatment of adult patients with advanced renal cell carcinoma (RCC) that has progressed following PD-1/L1 checkpoint inhibitor and vascular endothelial growth factor-tyrosine kinase inhibitor (VEGF-TKI) therapies.

Key Points: 
  • LITESPARK-005 is evaluating WELIREG for the treatment of adult patients with advanced renal cell carcinoma (RCC) that has progressed following PD-1/L1 checkpoint inhibitor and vascular endothelial growth factor-tyrosine kinase inhibitor (VEGF-TKI) therapies.
  • A statistically significant improvement in the trial’s key secondary endpoint of objective response rate (ORR) was also demonstrated.
  • A trend toward improvement in overall survival (OS), a dual primary endpoint, was observed; however, this result did not reach statistical significance.
  • The safety profile of WELIREG in this trial was consistent with that observed in previously reported studies.

Global Pancreatic Fistula Treatment Market Report 2022-2028: A $2+ Billion Market in 2021 - Higher Adoption of Surgical Techniques to Drive Market Growth - ResearchAndMarkets.com

Retrieved on: 
Tuesday, December 20, 2022
Surgery, Health, Adenocarcinoma, Medtronic, Somatostatin, Federation, Administration, Parenteral nutrition, Pancreatic fistula, ERCP, Cannula, Food, Vitamin, Pancreatic neuroendocrine tumor, US, Acquisition, Growth, Carbohydrate, Novartis, Fistula, Trauma, Unitary state, Mineral, Maximal and minimal elements, Pancreatic cancer, Pseudocyst, Prevalence, Biopsy, Pet, Medical imaging, Pharmaceutical industry, Marketing, Others

In 2021, surgical devices segment dominated the market owing to comparatively higher adoption of medical devices to diagnose and treat pancreatic fistula.

Key Points: 
  • In 2021, surgical devices segment dominated the market owing to comparatively higher adoption of medical devices to diagnose and treat pancreatic fistula.
  • Market is studied in order to understand the current and future market trends in the pancreatic fistula treatment market.
  • What are the key micro and macro environmental factors that are impacting the growth of Pancreatic Fistula Treatment market?
  • Who are the key competitors and what are their key strategies to enhance their market presence in the Pancreatic Fistula Treatment market worldwide?

Panavance Therapeutics Announces Publication of Encouraging Preclinical Data Evaluating GP-2250 for the Treatment of Pancreatic Neuroendocrine Carcinoma

Retrieved on: 
Thursday, June 9, 2022
Gemcitabine, Company, University of Duisburg-Essen, AG, Survival, Forward-looking statement, CEO, University Hospitals of the Ruhr-University of Bochum, Pancreatic neuroendocrine tumor, Hope, Ovarian cancer, University, Respiration (physiology), Ed, ST, Therapy, FDA, Development, Manuscript, GLOBE, Patient, Chemische Industrie Uithoorn, Incidence, Quality of life, Industry, Organ (anatomy), Wilms' tumor, General officer, PDX, Immortalised cell line, RECIST, Pancreas, Pharmaceutical industry, Panaveli, Cancer

BERWYN, Pa., June 09, 2022 (GLOBE NEWSWIRE) -- Panavance Therapeutics Inc. (“Panavance” or the “Company”), a clinical-stage pharmaceutical company advancing the development of a novel oncology therapeutic designed to disrupt cancer’s energy metabolism and improve quality of life for patients, today announced the publication of positive data from a preclinical study evaluating GP-2250 for the treatment of pancreatic neuroendocrine carcinoma. The manuscript titled, “New Therapy Options for Neuroendocrine Carcinoma of the Pancreas—The Emergent Substance GP-2250 and Gemcitabine Prove to Be Highly Effective without the Development of Secondary Resistances In Vitro and In Vivo1,” was published in the peer-reviewed journal, Cancers. 

Key Points: 
  • Neuroendocrine carcinoma of the pancreas is an aggressive form of neuroendocrine tumors which continue to increase in incidence but not in survival rates.
  • This study was the first to evaluate the effects of GP-2250 on pancreatic neuroendocrine tumors and we are very pleased with the encouraging results demonstrated.
  • This additional analysis suggests that GP-2250 may be valuable not only in pancreatic ductal adenocarcinoma but also in pancreatic neuroendocrine tumors.
  • Panavance is initially advancing development of GP-2250 for the treatment of pancreatic ductal adenocarcinoma cancer, and has active preclinical studies in numerous other cancers including ovarian cancer.

Global Sunitinib Malate Market Report to 2027 - Featuring Active Biotech, Astellas Pharma, AstraZeneca and Bristol Myers Squibb Among Others - ResearchAndMarkets.com

Retrieved on: 
Wednesday, June 1, 2022
Seniors, Biotechnology, Pharmaceutical, Oncology, Health, Chemicals, Plastics, Consumer, Manufacturing, Sunitinib, Pancreatic neuroendocrine tumor, Pancreatic cancer, Growth, Prevalence, Degenerative disease, GIST, CAGR, Gastrointestinal stromal tumor, Pharmaceutical industry

The global sunitinib malate market is anticipated to grow at a considerable CAGR during the forecast period.

Key Points: 
  • The global sunitinib malate market is anticipated to grow at a considerable CAGR during the forecast period.
  • The increasing prevalence of the gastrointestinal disorder is a creating demand for sunitinib malate market.
  • Expanding geriatric populace coupled with rising cases of pancreatic cancer are further supporting the growth of the global sunitinib malate market.
  • Based on application, the sunitinib malate market is segmented into pancreatic neuroendocrine tumors, advanced kidney cancer, gastrointestinal stromal tumor (GIST), and other.

End Drug Shortages Alliance Releases Market Assessment for Drugs Impacted by Manufacturing Plant Closure

Retrieved on: 
Tuesday, May 17, 2022
Other Manufacturing, Medical Supplies, Hospitals, Transport, Manufacturing, Practice Management, Health, Pharmaceutical, Logistics, Supply Chain Management, Diabetes, Risk, Teva, Patient, Solution, Adult, Pharmacy, Media, Oklahoma Hospital Association, Industry, Organization, Pancreatic neuroendocrine tumor, Cancer, CMTM, East End Drugs, Pharmaceutical industry, Risk management, Medicine, Alliance

The End Drug Shortages Alliance today announced it has released a market analysis of products affected by a recent Teva pharmaceutical manufacturing plant closure in Irvine, Calif.

Key Points: 
  • The End Drug Shortages Alliance today announced it has released a market analysis of products affected by a recent Teva pharmaceutical manufacturing plant closure in Irvine, Calif.
  • Information shared in this report highlights the level of transparency that is required across the supply chain to successfully navigate drug shortages.
  • All Alliance workstreams are aligned to the organizations objectives, including:
    Transparency and redundancy, including an early alert system for drug shortages.
  • To learn more about the End Drug Shortages Alliance, email [email protected] .

Onco360® Selected by Merck & Co., Inc. to Be in Specialty Pharmacy Network for WELIREG™ (belzutifan)

Retrieved on: 
Thursday, August 19, 2021
Pharmaceutical, Health, Oncology, CNS, Merck & Co., RCC, Merck, Central nervous system, Pnet, Hospital, Adult, VHL, Patient, PharMerica, Neoplasm, Oncology, Journal of Oncology Pharmacy Practice, Pancreatic neuroendocrine tumor, Hemangioblastoma, Pharmaceutical industry

Onco360 is honored to be included in the Merck specialty pharmacy network for WELIREG, said Benito Fernandez, Chief Commercial Officer, Onco360.

Key Points: 
  • Onco360 is honored to be included in the Merck specialty pharmacy network for WELIREG, said Benito Fernandez, Chief Commercial Officer, Onco360.
  • Onco360 is committed to supporting von Hippel-Lindau patients afflicted with certain associated tumors requiring treatment.
  • Onco360 is the largest independent Oncology Pharmacy and clinical support services company in the country.
  • Onco360 is headquartered in Louisville, Kentucky, and is a flagship specialty pharmacy brand of PharMerica Corporation, a leading institutional pharmacy, specialty infusion, and hospital services company servicing healthcare facilities in the United States.

VHL Community Celebrates Historic Treatment

Retrieved on: 
Wednesday, August 18, 2021
Cancer, Magnetic resonance imaging, Exocrine gland, Liver, Permanent Damage, Massachusetts General Hospital, Associate, CNS, Quality of life, Food and Drug Administration, Genetic disorder, Malignancy, Von Hippel–Lindau disease, Diagnosis, Family, Harvard Medical School, RCC, Research, Hope, Food, Kidney, Disease, Central nervous system, Pnet, Massachusetts, Pancreas, ORR, Breakthrough therapy, Wilms' tumor, Spine, Awareness, Mutation, Nobel Prize, Renal cell carcinoma, Risk, VHL, Adult, Patient, Caregiver, De novo, US Food Sovereignty Alliance, Education, Hospital, Neoplasm, FDA, Brain, Pancreatic neuroendocrine tumor, Hemangioblastoma, MD, Pharmaceutical industry

"The approval of belzutifan for treatment of VHL-related renal cancers, hemangioblastomas, and neuroendocrine tumors of the pancreas is a game-changer in the treatment of VHL patients," said Othon Iliopoulos, MD, Director, VHL Comprehensive Clinical Care Center at Massachusetts General Hospital and Harvard Medical School, Associate Professor of Medicine at Harvard Medical School.

Key Points: 
  • "The approval of belzutifan for treatment of VHL-related renal cancers, hemangioblastomas, and neuroendocrine tumors of the pancreas is a game-changer in the treatment of VHL patients," said Othon Iliopoulos, MD, Director, VHL Comprehensive Clinical Care Center at Massachusetts General Hospital and Harvard Medical School, Associate Professor of Medicine at Harvard Medical School.
  • The VHL Alliance (VHLA) is the preeminent resource and clearinghouse for those affected by von Hippel-Lindau disease, including patients, caregivers, researchers, and the medical community.
  • The VHL Alliance's vision is Curing Cancer through VHL.
  • For information about VHL and the VHL Alliance, please visit vhl.org .

HUTCHMED Announces NMPA Approval of Surufatinib (Sulanda® in China) for Advanced Pancreatic Neuroendocrine Tumors

Retrieved on: 
Friday, June 18, 2021
Cancer, Pancreatic cancer, Medical specialties, Clinical medicine, Pancreatic neuroendocrine tumor, Neuroendocrine tumor, Pnet, Pancreatic tumor, Endocrine oncology

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., June 18, 2021 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited ( HUTCHMED ) (Nasdaq/AIM: HCM) today announces that surufatinib has been granted approval for drug registration by the National Medical Products Administration of China (NMPA) for the treatment of advanced pancreatic neuroendocrine tumors (pNETs).

Key Points: 
  • HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., June 18, 2021 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited ( HUTCHMED ) (Nasdaq/AIM: HCM) today announces that surufatinib has been granted approval for drug registration by the National Medical Products Administration of China (NMPA) for the treatment of advanced pancreatic neuroendocrine tumors (pNETs).
  • This follows the approval of surufatinib in China in December 2020 for the treatment of advanced extra-pancreatic (non-pancreatic) neuroendocrine tumors (epNETs).
  • With todays approval, we are now able to provide this unique therapy to NET patients with pancreatic tumor origin as well.
  • This NMPA approval was supported by the SANET-p study, a Phase III pivotal study (clinicaltrials.gov identifier: NCT02589821 ) in patients with advanced pancreatic NETs conducted in China.