FDA Grants Regular Approval of Gavreto for Metastatic NSCLC Subset

The Food and Drug Administration (FDA) granted regular approval for Gavreto (pralsetinib) for the treatment of adults with metastatic RET fusion-positive non-small cell lung cancer (NSCLC).

In September 2020, the FDA granted Gavreto accelerated approval for patients with metastatic RET fusion-positive NSCLC.

The RET gene creates a protein that plays a role in cell growth, and when mutated, it may cause abnormal cells, including cancer cells, to grow, according to the National Cancer Institute. Approximately 1% to 2% of patients with NSCLC have RET-activating fusions, which can drive cancers in the lungs and medullary thyroid.

The accelerated and regular approvals were based on findings from the ARROW trial, which assessed Gavreto in patients with locally advanced or metastatic RET fusion-positive NSCLC. In particular, the accelerated approval was based on data from 114 patients, and the regular approval included data from an addition 123 patients and 25 months of follow-up, according to a statement from the agency.

The efficacy of Gavreto was demonstrated in 237 patients with locally advanced or metastatic RET fusion-positive NSCLC. Patients received this treatment until disease progression or unacceptable side effect profiles.

In the 107 patients in the ARROW trial who were not previously treated, the overall response rate (the proportion of patients with a complete or partial response to treatment) was 78% with a median duration of response (the time from a response to treatment until disease progression or all-cause death) of 13.4 months.

For the 130 patients from the trial who were previously treated with platinum-based chemotherapy, the overall response rate was 63% with a median duration of response of 38.8 months, according to the statement.

The most common side effects observed in the ARROW trial, occurring in at least 25% of patients, included constipation, musculoskeletal pain, diarrhea, high blood pressure, fever, swelling and cough.

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