FDA approves Gavreto for RET-altered thyroid cancers

The US Food and Drug Administration yesterday approved Blueprint Medicines’ (Nasdaq: BPMC) Gavreto (pralsetinib) for adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy or RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).

Earlier this year, the FDA granted accelerated approval to Gavreto for the treatment of adults with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test.

Blueprint Medicines and Genentech, a wholly-owned subsidiary of Swiss giant Roche (ROG: SIX), will co-commercialize Gavreto in the US and Roche has exclusive commercialization rights for Gavreto outside of the USA, excluding Greater China, under a deal signed in July that earned Blueprint at upfront $755 million and worth a potential $1.7 billion.