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FDA Accepts BMS's NDA for Repotrectinib in ROS1-Positive NSCLC

NEW YORK – The US Food and Drug Administration on Tuesday accepted for priority review Bristol Myers Squibb's new drug application seeking approval for repotrectinib as a treatment for ROS1-positive advanced or metastatic non-small cell lung cancer.

The FDA expects to decide whether to approve repotrectinib in this indication by Nov. 27. BMS submitted data from the Phase I/II TRIDENT-1 study, in which 79 percent of tyrosine kinase inhibitor (TKI)-naïve ROS1-positive NSCLC patients responded to repotrectinib in data from a pooled analysis reported last year. The drug was also efficacious in patients who had prior TKI treatment and in those with acquired resistance mutations to ROS1 inhibition.

"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," Jonathan Cheng, head of oncology development at BMS, said in a statement. "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."

For TKI-naïve metastatic NSCLC patients with ROS1 rearrangements there are currently two targeted treatment options: Pfizer's Xalkori (crizotinib) or Genentech's Rozlytrek (entrectinib).

BMS added repotrectinib to its pipeline with the $4.1 billion acquisition of Turning Point Therapeutics last year. The firm is also studying repotrectinib in NTRK-positive solid tumors in a Phase II study. Rozlytrek and Bayer's Vitrakvi (larotrectinib) are approved in the US for treating NTRK-positive refractory solid tumors.