FDA grants regular approval to Gavreto for lung cancer subset
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The FDA granted regular approval to pralsetinib for treatment of certain patients with non-small cell lung cancer.
The indication applies to use of the agent for adults with metastatic NSCLC who harbor RET gene fusions detected by an FDA-approved test.
The agency granted accelerated approval to pralsetinib (Gavreto, Genentech) for this indication in September 2020 based on initial data related to overall response and response duration from the multicenter, open-label ARROW trial, which included patients with locally advanced or metastatic RET fusion-positive NSCLC.
The FDA converted the accelerated approval to regular approval based on data from additional trial participants, plus another 25 months of follow-up that allowed for additional assessment of response durability.
The 237 trial participants received pralsetinib until disease progression or unacceptable toxicity.
ORR and duration of response per blinded independent review committee served as the primary efficacy measures.
Analyses of 107 treatment-naive patients showed an ORR of 78% (95% CI, 68-85), with a median duration of response of 13.4 months (95% CI, 9.4-23.1).
Analyses of 130 trial participants who previously received platinum-based chemotherapy showed an ORR of 63% (95% CI, 54-71), with a median response duration of 38.8 months (95% CI, 14.8 to not estimable).
The most common adverse reactions reported among at least 25% of trial participants included musculoskeletal pain, constipation, hypertension, diarrhea, fatigue, edema, pyrexia and cough.
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