FDA Approves Augtyro (repotrectinib) for Adults and Children with NTRK-Positive Solid Tumors

[Miranda_GO2]

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 both non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). 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.

Here is the link to the full FDA approval: fda.gov/drugs/resources-inf...