FDA accelerates approval of new-generation TKI Augtyro (repotrectinib) for treating solid tumors with NTRK gene fusion in adults and pediatric patients aged 12+.

The FDA has granted accelerated approval to Augtyro (repotrectinib), a new-generation tyrosine kinase inhibitor (TKI), for treating adult and pediatric patients aged 12 years and older with solid tumors having an NTRK gene fusion. The approval is based on the TRIDENT-1 study, which reported a confirmed overall response rate of 58% for treatment-naive patients and 50% for those who previously received a TKI inhibitor. Common side effects include dizziness, dysgeusia, and peripheral neuropathy.

June 13, 2024
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