FDA accepts Tecentriq filing for priority review for ES-SCLC

The US Food and Drug Administration has accepted the supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq (atezolizumab), in combination with carboplatin and etoposide (chemotherapy), for the initial (first-line) treatment of people with extensive-stage small cell lung cancer (ES-SCLC), submitted by Swiss pharma giant Roche (RG: SIX).

The FDA is expected to make a decision on approval by March 18, 2019. A Priority Review designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a serious disease.

Tecentriq is already one of Roche’s fastest-growing new drugs, posting sales of 524 million Swiss francs ($524.5 million) in the first nine months of this year, up 49% on the like, prior year figure.