NEW YORK – Genentech said on Wednesday that its supplemental Biologics License Application for atezolizumab (Tecentriq) was accepted by the US Food and Drug Administration and granted priority review.
The company is pursuing approval for the drug as a first-line, monotherapy option for advanced non-small cell lung cancer patients with high PD-L1 expression, and who don't harbor EGFR or ALK mutations. It expects to hear back from the FDA on its application by mid-June.