Pnet

Exelixis Announces Preliminary Fiscal Year 2023 Financial Results, Provides 2024 Financial Guidance, and Outlines Key Priorities and Milestones for 2024

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일요일, 1월 7, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Associate, Baylor College of Medicine, PKMYT1, BRCA, FDA, Breast, Progression-free survival, Society, Insilico Medicine, Cancer, Distinguishing, Translational research, Neck, PLK4, Workforce, Conference, Translation, Biology, IND, Colorectal cancer, MSN, NHT, University, PARP, Doctor of Philosophy, Calendar, District court, Harvard University, Immunotherapy, Food, Johnson & Johnson, NET, Huntsman Corporation, Cell adhesion, Therapy, TKI, USP1, Neoplasm, Experiment, Patient, NCI, Corporation, Baylor University, Huntsman Cancer Institute, Research, Acquisition, Dean (education), Education, Pnet, Head, Shareholder, Share repurchase, PFS, ADC, Pharmaceutical industry

The preliminary 2023 financial information presented in this press release has not been audited and is subject to change.

Key Points: 
  • The preliminary 2023 financial information presented in this press release has not been audited and is subject to change.
  • The complete Exelixis Fourth Quarter and Fiscal Year 2023 Financial Results are planned for release after market on Tuesday, February 6, 2024.
  • Exelixis expects to substantially complete the restructuring in the first quarter of 2024 and recognize a restructuring charge of approximately $25 million.
  • In 2024, the company expects to designate two new programs to DC status, including a small molecule PLK4 inhibitor and an additional ADC.

Detailed Results from Phase 3 CABINET Pivotal Trial Evaluating Cabozantinib in Advanced Neuroendocrine Tumors Presented at ESMO 2023

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일요일, 10월 22, 2023
Biotechnology, General Health, Health, Pharmaceutical, Clinical Trials, Exelixis, National Institutes of Health, NCI, ESMO, Progression-free survival, Alliance for Clinical Trials in Oncology, Physician, Congress, PFS, European Society for Medical Oncology, Dana–Farber Cancer Institute, Glomus tumor, Data monitoring committee, Disease, NET, National Cancer Institute, Oncology, CET, NETS, EXEL, Pnet, Patient, Bangladesh Technical Education Board, DSMB, Pharmaceutical industry, Medical imaging, Carcinoid

Exelixis, Inc. (Nasdaq: EXEL) today announced detailed results from CABINET, a phase 3 pivotal trial evaluating cabozantinib (CABOMETYX®) compared with placebo in two cohorts of patients with previously treated neuroendocrine tumors: one cohort of patients with advanced pancreatic neuroendocrine tumors (pNET) and a second cohort of patients with advanced extra-pancreatic NET (epNET).

Key Points: 
  • Exelixis, Inc. (Nasdaq: EXEL) today announced detailed results from CABINET, a phase 3 pivotal trial evaluating cabozantinib (CABOMETYX®) compared with placebo in two cohorts of patients with previously treated neuroendocrine tumors: one cohort of patients with advanced pancreatic neuroendocrine tumors (pNET) and a second cohort of patients with advanced extra-pancreatic NET (epNET).
  • “Although progress has been made in recent years, there remains a critical need for new and effective therapies for patients with advanced neuroendocrine tumors.
  • Results from the CABINET study presented today at ESMO demonstrate that treatment with cabozantinib resulted in compelling improvements in PFS based both on local review and on independent blinded central radiology review.
  • The safety profile of cabozantinib observed in each cohort was consistent with its known safety profile; no new safety signals were identified.

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

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목요일, 8월 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.”

HUTCHMED Receives Complete Response Letter from the U.S. FDA for Surufatinib for the Treatment of Advanced Neuroendocrine Tumors

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월요일, 5월 2, 2022
CRL, EDT, Wilms' tumor, Population, PFS, SANET, GLOBE, NDA, Lancet, Food, Safety, Physician, Endpoint security, Patient, NET, HCM, FGFR, Review, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, New Drug Application, Pnet, Tumor-associated macrophage, HKT, BST, VEGFR, Pharmaceutical industry, Agency

Surufatinib was approved in China for the treatment of pNETs and epNETs in June 2021 and December 2020, respectively.

Key Points: 
  • Surufatinib was approved in China for the treatment of pNETs and epNETs in June 2021 and December 2020, respectively.
  • Surufatinib received U.S. FDA Fast Track Designations in April 2020 for the treatment of pNETs and epNETs.
  • The FDA evaluated the applicability of the SANET studies data generated in one country to U.S. patients and U.S. medical practice.
  • epNETs in China: On December 29, 2020, surufatinib was granted drug registration approval in China for the treatment of epNET.

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

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목요일, 8월 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

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수요일, 8월 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

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금요일, 6월 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.