BMS’ Augtyro Wins FDA Accelerated Approval for NTRK-Positive Solid Tumors

Published: Jun 14, 2024 By Tristan Manalac

BMS in California/iStock, JHVEPhoto

Pictured: BMS’s office in San Diego, California/iStock, JHVEPhoto

Bristol Myers Squibb on Thursday announced that its tyrosine kinase inhibitor Augtyro (repotrectinib) was granted accelerated approval by the FDA for the treatment of NTRK-positive, locally advanced or metastatic solid tumors.

Under the new indication, Augtyro can be used in patients aged 12 years and older whose disease has progressed after initial treatment. Augtyro can also be used in patients with no satisfactory alternative therapies or in those who are likely to suffer from “severe morbidity” due to surgical resection, according to the company.

Under the FDA’s accelerated pathway and to keep Augtyro’s approval, BMS will need to run a confirmatory study to validate the clinical benefit of the drug in this indication and patient population.

Nick Botwood, senior vice…
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