Two-year follow-up data were reported from the Phase III CheckMate -9ER trial of Bristol Myers Squibb’s checkpoint inhibitor Opdivo (nivolumab) and Exelixis’ Cabometyx (cabozantinib) in the first-line treatment of advanced renal cell carcinoma.
The U.S. Food and Drug Administration approved Novartis’ first-in-class Scemblix (asciminib) for two indications in the treatment of chronic myeloid leukemia (CML).
The U.S. Food and Drug Administration approved Pfizer’s Xalkori (crizotinib) for pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma that is anaplastic lymphoma kinase-positive.
U.S. FDA Approves Takeda’s Iclusig for Adults with Resistant or Intolerant Chronic-Phase CML
Approvals, Blockbusters, Chronic Myeloid Leukemia (CML), Chronic-Phase (CP) Chronic Myeloid Leukemia (CML), Clinical Data, Clinical Trials, FDA, New Indications, R&D, Supplemental New Drug Application (sNDA), Takeda, Therapeutics, Tyrosine kinase inhibitorsThe U.S. Food and Drug Administration approved Takeda Pharmaceutical’s supplemental New Drug Application for Iclusig (ponatinib) for adult patients with chronic-phase chronic myeloid leukemia with resistance or intolerance to at least two prior kinase inhibitors.
News Brief: Merck, Eisai, Sherlock, Bill & Melinda Gates Foundation and More
Adeno-Associated Virus (AAV), Biopharma, Calcitonin Gene-Related Peptide (CGRP) Inhibitors, CCR5 antagonists, Clinical Trials, Data, Endometrial Cancer, GLB1 gene, Hospitalized COVID-19 Patients, Metastatic Colorectal Cancer (mCRC), Overall Response Rate (ORR), R&D, The Bill and Melinda Gates Foundation, The Lancet, Tyrosine kinase inhibitors, United KingdomA roundup of biopharma news and updates includes Merck and Eisai’s Keytruda-Lenvima combo hitting the mark in a Phase III study for advanced endometrial cancer.
A dual treatment approach consisting of gemcitabine combined with AB Science’s highly selective tyrosine kinase inhibitor masitinib was associated with significant increases in survival among patients with pancreatic cancer and pain, according to recently announced results from a confirmatory Phase III study.
Merck and Seattle Genetics Ink Two New Strategic Cancer Collaborations
Antibody-Drug Conjugates (ADCs), Blockbusters, Business, Cancer, Checkpoint Inhibitors, Clinical Trials, Collaborations, Deals, HER2 protein, Investments, Licensing, Oncology, Premarket Trading, R&D, Small Molecules, Solid Tumors, Triple Negative Breast Cancer (TNBC), Tyrosine kinase inhibitorsSeattle Genetics’ shares rocketed after news broke of Merck making a major investment into the Bothwell, Washington-based company via two strategic oncology deals.
Novartis drug candidate asciminib notched a trial win against Pfizer’s Bosulif as the Swiss drugmaker pushes to expand medicines for chronic myeloid leukemia in patients for whom other treatments stopped working.
The U.S. Food and Drug Administration approved Takeda Pharmaceutical Company Limited’s Alunbrig (brigatinib) for adult patients with anaplastic lymphoma kinase-positive metastatic non-small cell lung cancer as detected by an FDA-approved test.
AVEO Oncology Announces Submission of New Drug Application to U.S. FDA for Tivozanib in Patients with Relapsed or Refractory Renal Cell Carcinoma
FDA, FDA/Regulatory, Immunotherapy, New Drug Application Submission, Renal Cell Carcinoma (RCC), Tyrosine kinase inhibitors, Vascular Endothelial Growth Factor (VEGF) InhibitorsAVEO Oncology submitted a New Drug Application to the U.S. Food and Drug Administration for tivozanib, the company’s vascular endothelial growth factor receptor tyrosine kinase inhibitor, as a treatment for relapsed or refractory renal cell carcinoma (RCC).