On June 13, 2024, Bristol-Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to repotrectinib for the treatment of adults and children aged 12 years and older with solid tumors harboring neurotrophic tyrosine receptor kinase (NTRK) gene fusions that are locally advanced or metastatic, or whose surgical resection would result in severe morbidity, and whose disease has progressed after treatment or for whom there is no satisfactory alternative therapy.
This approval is based on results from the Phase 1/2 TRIDENT-1 study, which evaluated the efficacy of repotrectinib in adult patients with NTRK-positive solid tumors. This indication received accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon validation and description of clinical benefit in confirmatory trials.
“NTRK fusion-positive tumors can present numerous challenges in clinical treatment, making it crucial to provide these patients with more treatment options,” said Alexander Dr., MD, Head of the TRIDENT-1 Global Trial and Director of the Early Drug Development Service at Memorial Sloan Kettering Cancer Center. “FDA approval of Repotrectinib adds an important tool to our treatment toolkit, providing oncologists with a next-generation tyrosine kinase inhibitor (TKI) for a broad range of patients with NTRK fusion-positive solid tumors, including both TKI-naïve and TKI-treated patients.”
Repotrectinib Development Process:
June 13, 2024:
Approval: The U.S. Food and Drug Administration (FDA) approved Repotrectinib for the treatment of patients with NTRK-positive locally advanced or metastatic solid tumors.
November 16, 2023:
Approval: The U.S. Food and Drug Administration (FDA) approved Repotrectinib for the treatment of patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer.
August 16, 2023:
Updated data from the TRIDENT-1 trial demonstrated that repotrectinib provides durable efficacy benefit in patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer.
May 30, 2023:
The U.S. Food and Drug Administration (FDA) accepted Bristol-Myers Squibb's Priority Review application for repotrectinib for the treatment of patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer.
July 27, 2022:
TurningPoint Therapeutics released regulatory updates regarding repotrectinib for the treatment of ROS1-positive advanced non-small cell lung cancer.
