Alecensa alectinib regulatory update

FDA accepted and granted Priority Review to an NDA from Roche’s Genentech unit for alectinib to treat anaplastic lymphoma kinase (ALK)-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients who have progressed on or are intolerant to crizotinib. The PDUFA date is March 4, 2016. The NDA includes data from the Phase II NP28761 and NP28673 trials (see BioCentury, May 25). The compound has breakthrough therapy designation in the U.S. for the indication. ...