FDA accepts Imfinzi sBLA for priority review in SCLC

The US Food and Drug Administration has accepted a supplemental Biologics License Application (sBLA) and granted Priority Review for Imfinzi (durvalumab) for the treatment of patients with previously untreated extensive-stage small cell lung cancer (SCLC), says Anglo-Swedish pharma major AstraZeneca (LSE: AZN).

SCLC is an aggressive, fast-growing form of lung cancer that recurs and progresses rapidly despite initial response to platinum-based chemotherapy. A Prescription Drug User Fee Act date is set for the first quarter of 2020, which, if positive could mean that the new indication would be useable thereafter.

If approved, Imfinzi (durvalumab) would compete directly with Roche’s (ROG: SICX) Tecentriq (atezolizumab), which was approved for previously-untreated SCLC in the US earlier this year. Leading the NSCLC sector market is Merck & Co’s (NYSE: MRK) PD-1 inhibitor Keytruda (pembrolizumab), which is already approved for third-line SCLC treatment.