FDA Grants Priority Review to Bristol Myers Squibb's Application for Repotrectinib in Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer
Tuesday, May 30, 2023
Bristol Myers Squibb (NYSE: BMY) has 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). The FDA has granted the application Priority Review, and the Prescription Drug User Fee Act (PDUFA) goal date for a decision is set for November 27, 2023.
ROS1-positive NSCLC is a rare form of lung cancer with limited treatment options. If approved, repotrectinib would provide a potential new treatment option for both TKI-naïve patients and those who have previously received TKIs but currently have no approved targeted therapies available. The drug has demonstrated promising results in terms of response rates and durability of benefit in both patient populations, including those with ROS1 resistance mutations.
The NDA filing is based on data from the TRIDENT-1 study, a Phase 1/2 clinical trial evaluating the safety, tolerability, pharmacokinetics, and anti-tumor activity of repotrectinib in patients with advanced solid tumors, including NSCLC. The study has shown favorable response rates and durability of benefit, with a well-characterized and manageable safety profile for repotrectinib. The trial is still ongoing to evaluate long-term outcomes and additional endpoints in various patient populations.
Bristol Myers Squibb acquired Turning Point Therapeutics, the company developing repotrectinib, in August 2022. Repotrectinib, also known as TPX-0005 or BMS-986472, is a next-generation TKI designed to target ROS1- or NTRK-positive solid tumors, including NSCLC. The drug aims to provide improved durability of response and enhanced intracranial activity. It has received Orphan Drug designation and Breakthrough Therapy Designations from the FDA for various indications.
Lung cancer is the leading cause of cancer-related deaths worldwide, and NSCLC accounts for a significant proportion of cases. ROS1 fusions occur in approximately 1-2% of NSCLC patients, and targeted therapies are preferred for patients with this genetic alteration. Bristol Myers Squibb is committed to advancing cancer research and developing innovative treatments to improve outcomes and provide hope for individuals with cancer.
