On June 13, 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval of Augtyro (repotrectinib) for adults and children aged 12 years and older with NTRK-positive solid tumors, including non-small cell lung cancer (NSCLC). The new approval for Augtyro (repotrectinib) applies to people:
- With locally advanced or metastatic disease, or people where surgical resection is likely to result in severe harm or death.
- Who have progressed on previous treatments or have no other good treatment options available.
The approval is based on results from the TRIDENT-1 study, which evaluated using Augtyro (repotrectinib) as a first- or second-line therapy in people with locally advanced or metastatic NTRK-positive solid tumors. People receiving Augtyro (repotrectinib) as a first-line treatment showed a significant response rate and a prolonged benefit when receiving the therapy. Similarly, those given Augtyro (repotrectinib) after previously receiving an NTRK-targeted therapy also experienced a meaningful response.
NTRK mutations are rare in lung cancer, with a frequency of less than 1%. This approval represents a new treatment option, and renewed hope, for people with NTRK-positive solid tumors.
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