The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS; NYSE: BMY) an accelerated approval for its next-generation tyrosine kinase inhibitor (TKI), Augtyro (repotrectinib), for the treatment of locally advanced, metastatic, or unresectable NTRK fusion-positive solid tumors. This decision follows the drug’s progression after treatment or in cases where no satisfactory alternative therapy exists, expanding on its original indication for ROS1-positive non-small cell lung cancer (NSCLC) obtained last year.
The FDA’s decision is supported by data from a Phase I/II trial, which demonstrated confirmed objective response rates (cORR) of 58% for TKI-naive participants and 50% for TKI-pretreated participants. The trial also showed complete response rates of 15% and 0% respectively. Furthermore, 83% and 42% of responders maintained their response after one year, indicating the potential durability of the treatment’s effects.- Flcube.com
