FDA approves BMS lung cancer drug

Nov. 16, 2023

The U.S. FDA has green-lit Bristol-Myers Squibb’s next-generation tyrosine kinase inhibitor, offering a new treatment option for ROS1-positive non-small cell lung cancer (NSCLC) patients.

The drug, now branded Augtyro, was the driving force behind BMS' $4.1 billion acquisition of Turning Point Therapeutics in June 2022.

The approval was based on the high objective response rate and durable response in the TRIDENT-1 trial. In TKI-naïve patients, the primary endpoint of objective response rate was 79% during the open-label, single-arm, phase 1/2 trial. Patients pretreated with one prior ROS1 TKI and no prior chemotherapy saw an objective response rate of 38%.

Augtyro will be entering a crowded lung cancer treatment market that includes BMS’ own blockbuster Opdivo, Pfizer’s Xalkori and Roche’s Rozlytrek. However, Augtyro is the only approved next-generation TKI for ROS1-positive NSCLC patients — offering a new treatment option for the group.

The drug is expected to be available to patients by mid-December 2023.