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FDA Regular Approval of Pralsetinib for RET Fusion-Positive NSCLC
August 2023: Pralsetinib (Gavreto, Genentech, Inc.) was given regular approval by the Food and Drug Administration for adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC), as determined by an FDA-approved test.
Based on the initial overall response rate (ORR) and durability of response (DOR) in 114 patients participating in the ARROW study (NCT03037385), a multicenter, open-label, multi-cohort trial, pralsetinib was previously given expedited approval for the NSCLC indication on Sept. 4, 2020. Based on information from 123 more patients and an additional 25 months of follow-up to gauge the longevity of the response, the conversion to regular approval was made.
ARROW Study Efficacy and Response Durability
A total of 237 patients with locally progressed or metastatic RET fusion-positive NSCLC showed efficacy. Patients were given pralsetinib until the disease progressed or the side effects were intolerable.
A Blinded Independent Review Committee (BIRC) decided that ORR and DOR were the key efficacy measures. The ORR was 78% (95% CI: 68, 85) among 107 patients who had never received therapy, and the median DOR was 13.4 months (95% CI: 9.4, 23.1). The ORR was 63% (95% CI: 54, 71) among 130 patients who had previously had platinum-based chemotherapy, and the median DOR was 38.8 months (95% CI: 14.8, not estimable).
Musculoskeletal discomfort, constipation, hypertension, diarrhoea, weariness, edoema, pyrexia, and cough were the most frequent side effects ( 25%).
400 mg of pralsetinib taken orally once per day is the recommended dosage. It is recommended to take pralsetinib on an empty stomach (no food for at least 2 hours prior to and at least 1 hour following the administration of pralsetinib).
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About Dr. Nishant Mittal
Dr. Nishant Mittal is a highly accomplished researcher with over 13 years of experience in the fields of cardiovascular biology and cancer research. Significant contributions to stem cell biology, developmental biology, and innovative research techniques mark his career. Research Highlights Dr. Mittal's research has focused on several key areas: 1) Cardio…
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This article is for educational purposes only and should not replace medical advice, diagnosis, or treatment from a qualified oncology specialist. Every patient's case is different. Treatment decisions should always be made after a review of complete medical records by the treating medical team.
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