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FDA Approves BMS's Augtyro for Advanced ROS1-Positive NSCLC

NEW YORK – The US Food and Drug Administration on Wednesday approved Bristol Myers Squibb's tyrosine kinase inhibitor Augtyro (repotrectinib) for patients with advanced non-small cell lung cancer whose tumors harbor ROS1 gene alterations.

The agency based its approval on the results of the Phase I/II TRIDENT-1 clinical trial, in which 79 percent of NSCLC patients who had not received prior ROS1 TKIs responded to Augtyro, and the same was true of 38 percent of NSCLC patients who had received prior ROS1 TKIs but had not received prior chemotherapy. Of patients in the TKI-naïve group whose cancers had metastasized to their central nervous systems, seven out of eight responded to Augtyro. Among TKI-pretreated patients with these central nervous system metastases, five out of 12 patients responded.

In a statement, BMS noted Augtyro is the first next-generation ROS1 TKI approved for NSCLC. Earlier ROS1 TKIs already on the market for NSCLC include Genentech's Rozlytrek (entrectinib) and Pfizer's Xalkori (crizotinib).

BMS gained the rights to Augtyro when it bought the drug's developer, Turning Point Therapeutics, in a $4.1 billion deal last year. The acquisition also expanded BMS's pipeline to include the MET inhibitor elzovantinib, the RET inhibitor TPX-0046, and the ALK inhibitor TPX-0131.