Priority Review for Roche drug in first-line ALK-positive lung cancer

The US Food and Drug Administration (FDA) has granted Priority Review to a supplemental New Drug Application (sNDA) for Alecensa (alectinib) (first-line) as a treatment for people with anaplastic lymphoma kinase (ALK)-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.

Alecensa, from Swiss pharma giant Roche’s (ROG: SIX) Genentech unit, has already been approved by the FDA for ALK-positive metastatic NSCLC patients who have progressed on or are intolerant to crizotinib.

The FDA will make a decision on whether to grant the further approval by November 30 this year, having already granted Alecensa Breakthrough Therapy designation in this new indication to expedite its development and review. The sNDA submission is based on results from the Phase III ALEX and Phase III J-ALEX studies.