FDA grants Gavreto regular approval for NSCLC with RET gene fusions

First granted US accelerated approval in 2020, the Food and Drug Administration on Wednesday converted this to regular approval of Gavreto (pralsetinib) for adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.

Pralsetinib was discovered by US biotech Blueprint Medicines (Nasdaq: BPMC) but was out-licensed to Roche’s (ROG: SIX) subsidiary’s Genentech.

However, in February this year, two and half years after the Swiss pharma giant paid $775 million up front to in-license the RET inhibitor, as part of a $1.7 billion agreeement with Blueprint, Roche pulled out of the deal to develop Gavreto, citing “strategic reasons.”