FDA granted regular approval to Gavreto (pralsetinib) for adult patients with metastatic rearranged during transfection fusion-positive non-small cell lung cancer as detected by an FDA-approved test.
Gavreto is sponsored by Genentech Inc.
Gavreto was previously granted accelerated approval for the NSCLC indication on Sept. 4, 2020, based on initial overall response rate and duration of response in 114 patients enrolled in the ARROW trial—, a multicenter, open-label, multi-cohort trial. The conversion to regular approval was based on data from an additional 123 patients and 25 months of additional follow-up to assess durability of response.
Full prescribing information for Gavreto can be found on FDA’s website.
Efficacy was demonstrated in a total of 237 patients with locally advanced or metastatic RET fusion-positive NSCLC. Patients received Gavreto until disease progression or unacceptable toxicity.
The primary efficacy measures were ORR and DOR as determined by a Blinded Independent Review Committee. Among 107 treatment-naïve patients, ORR was 78% with a median DOR of 13.4 months. Among 130 patients previously treated with platinum-based chemotherapy, ORR was 63% with a median DOR of 38.8 months.
The most common adverse reactions were musculoskeletal pain, constipation, hypertension, diarrhea, fatigue, edema, pyrexia, and cough.
