FDA Accepts for Priority Review Bristol Myers Squibb’s Application for Augtyro
Zai Lab Announces The New England Journal of Medicine Publication Demonstrating
EMA Validates Bristol Myers Squibb’s Application for Repotrectinib
US FDA approves Bristol-Myers` lung cancer drug
The Center for Drug Evaluation, of the National Medical Products Administration (NMPA) in China, has granted breakthrough therapy designation to repotrectinib for use in patients with advanced solid tumors harboring a NTRK gene fusion who experienced disease progression after TKI treatment.1
China’s National Medical Products Administration’s Center for Drug Evaluation has granted breakthrough therapy designation to Zai Lab’s repotrectinib for treating patients with NTRK-positive advanced solid tumours.
Updated Data from TRIDENT-1 Trial Show Durable Efficacy Benefits with Repotrectinib for Patients with Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer
The National Medical Products Administration (NMPA) in China has accepted for review a new drug application (NDA) seeking the approval of repotrectinib for use in adult patients with locally advanced or metastatic ROS1-positive non–small cell lung cancer (NSCLC).1
The FDA has granted a marketing application for Bristol Myers Squibb's next-generation tyrosine kinase inhibitor (TKI) repotrectinib a priority review for the treatment of patients with ROS1-positive, locally advanced or metastatic non-small-cell lung cancer (NSCLC). In a statement Tuesday, the company said the FDA assigned a target action date of November 27.
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for repotrectinib, a next-generation tyrosine kinase inhibitor (TKI), for the treatment of patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC), based on results from the TRIDENT-1 trial. The FDA granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of November 27, 2023.