The US Food and Drug Administration (FDA) has accepted Bristol Myers Squibb’s new drug application (NDA) for repotrectinib for priority review.
Repotrectinib is a tyrosine kinase inhibitor (TKI) intended to treat patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).
Its favourable properties for penetrating the human brain increase intracranial activity.
The NDA was based on data from the first-in-human, open-label, global, multi-centre TRIDENT-1 trial.
The Phase I/II study assessed the pharmacokinetics, tolerability, safety and anti-tumour activity of repotrectinib in patients with advanced NSCLC.
Phase I of the trial has a number of primary and secondary safety and pharmacokinetics endpoints.
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Overall response rate as measured by blinded independent central review (BICR) using RECIST v1.1 is the primary endpoint of the Phase II study. Secondary endpoints include progression-free survival, time to response, duration of response and overall survival.
Further secondary endpoints include measuring the clinical benefit rate in six distinct expansion cohorts, including NTRK-positive advanced solid tumours and TKI-pretreated and TKI-naïve patients with ROS1-positive metastatic NSCLC.
Bristol Myers Squibb senior vice-president and oncology development head Jonathan Cheng stated: “The FDA’s acceptance of this application marks an exciting milestone on our journey to bring this next-generation tyrosine kinase inhibitor to patients.
“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.
“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.”
The FDA has assigned a prescription drug user fee act action date of 27 November 2023 for the NDA.