FDA Accepts New Drug Application for Tyrosine Kinase Inhibitor to Treat NSCLC Subset


The agency accepted a New Drug Application for repotrectinib, a TKI for the treatment of patients with locally advanced or metastatic non-small cell lung cancer.

FDA on a blue background

The FDA will review repotrectinib for the treatment of certain patients with non-small cell lung cancer.

The Food and Drug Administration (FDA) accepted a New Drug Application for the tyrosine kinase inhibitor, repotrectinib, for the treatment of ROS1-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC).

In patients with ROS1-positive disease, cancer cells with the ROS1 fusion protein or a change in the ROS1 gene may grow more quickly, according to the National Cancer Institute. Knowing a patient’s ROS1 status can help cancer teams plan treatment.

“Patients with ROS1-positive non-small cell lung cancer face a rare disease with a significant unmet medical need given the limited durability of benefit and emergence of resistance to approved therapies,” Dr. Jonathan Cheng, senior vice president and head of oncology development for Bristol Myers Squibb, said in a press release from the company, the manufacturer of repotrectinib. “The FDA’s acceptance of this application marks an exciting milestone on our journey to bring this next-generation tyrosine kinase inhibitor to patients.”

With the acceptance of this New Drug Application, the FDA will assess the safety and effectiveness of repotrectinib, among other factors, to decide upon its potential approval for a given patient population. In particular, the FDA will be reviewing results from the TRIDENT-1 trial, which evaluated the safety, tolerability and activity of repotrectinib in patients with advanced solid tumors, which included NSCLC.

Researchers conducting the TRIDENT-1 trial focused on several factors including overall response rate (percentage of patients with a partial or complete response to treatment), duration of response, time to response, overall survival (the time from treatment when a patient with cancer is alive), progression-free survival (the time during and after treatment when a patient with cancer lives with the disease without worsening) and clinical benefit rate (percentage of patients who disease shrank or remained stable).

“If approved, this would represent a potential best-in-class option for TKI-naïve patients and a potential first-in-class option for patients with ROS1-positive NSCLC who have been previously treated with TKI, and for whom there are currently no approved targeted therapies available,” Cheng said. “We are eager to continue working closely with the FDA on the review of this precision medicine, which has shown (an) unprecedented level of durability of responses and robust intracranial responses in patients with ROS1-positive NSCLC.”

According to the ClinicalTrials.gov listing, the TRIDENT-1 trial estimates enrolling 500 patients with advanced solid tumors harboring ALK, ROS1 or NTRK1-3 rearrangements. The trial is estimated to be completed by December 2024.

The FDA assigned Nov. 27, 2023 as a deadline to make its decision on repotrectinib, according to the release.

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