FDA grants regular approval to Gavreto for adult patients with metastatic RET fusion–positive non–small cell lung cancer as detected by an FDA-approved test.- Blueprint Medicines + Genentech/Roche
The FDA has granted regular approval to pralsetinib (Gavreto) for adult patients with metastatic RET fusion–positive non–small cell lung cancer (NSCLC), as detected by an FDA-approved test
In September 2020, the regulatory agency had granted accelerated approval to the agent for this indication based on findings on overall response rate (ORR) and duration of response (DOR) from the phase 1/II ARROW trial (NCT03037385).
Pralsetinib had induced an ORR of 57% (95% CI, 46%-68%), which included a complete response (CR) rate of 5.7% in patients with NSCLC who received prior treatment with platinum-based chemotherapy (n = 87). The median DOR in this group had not yet been reached (95% CI, 15.2-not reached). In treatment-naïve patients (n = 27), the ORR with the agent was even higher, at 70% (95% CI, 50%-86%), and the CR rate was 11%.
The conversion to regular approval was based on findings from an additional 123 patients and 25 months of additional follow-up to evaluate durability of response with the product.
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