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And the Accelerated Approval Goes to… Repotrectinib

June 13, 2024

The FDA has granted accelerated approved to repotrectinib (Augtyro; Bristol Myers Squibb) for some patients age 12 and older with solid tumors harboring an NTRK gene fusion; specifically, the drug is indicated for these patients if they have locally advanced or metastatic disease—or if surgery is likely to cause severe morbidity—and if their disease has advanced despite treatment or has no other satisfactory therapy. Efficacy was assessed in the TRIDENT-1 study, which included 88 patients who could’ve already been treated with a TRK tyrosine kinase inhibitor (TKI). The overall response rate in the TKI-naive group was 58% compared with 50% in the group that had already received a TKI. The duration of response was not estimable and 9.9 months, respectively.

 

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