FDA Approves Pralsetinib for RET Fusion–Positive NSCLC

FDA Approves Pralsetinib for RET Fusion–Positive NSCLC

Industry News & Regulatory Approvals
Oct 01, 2020
Regulatory Approval

The US Food and Drug Administration (FDA) granted Accelerated Approval to pralsetinib as treatment for adults with metastatic NSCLC who harbor RET fusions. The first and only test to identify RET fusion–positive NSCLC, the Oncomine Dx Target Test, was granted premarket approval as a companion diagnostic for pralsetinib therapy. The test will be updated to report RET fusions by early 2021 in the United States. Pralsetinib’s approval was based on data from the phase I/II ARROW study in patients with RET fusion–positive NSCLC who did or did not have prior therapy. Of 87 patients with NSCLC who had received prior treatment with a platinum-based chemotherapy, the overall response rate (ORR) was 57% (95% CI: 46%-68%) with a complete response (CR) rate of 5.7%. The median duration of response was not reached (95% CI: 15.2 months-NR). The ORR for treatment-naive patients (N = 27) was 70% (95% CI: 50%-86%), and the CR rate was 11%.

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