EC green lights Gavreto for RET fusion-positive advanced NSCLC

The European Commission (EC) has granted conditional marketing authorization for Gavreto (pralsetinib) as a monotherapy for the treatment of adults with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor.

Developed by Swiss pharma giant Roche (ROG: SIX) and Blueprint Medicines (Nasdaq: BPMC), Gavreto is the first and only precision medicine approved in the European Union for the first-line treatment of people with RET fusion-positive advanced NSCLC.

The drug was approved in the USA for this indication in September last year and also for transfection (RET) fusion-positive NSCLC). SVB Leerink Research analysts forecasts peak annual US Gavreto revenues of ~$887 million.