Alecensa alectinib regulatory update

FDA granted accelerated approval to Alecensa alectinib from the Genentech unit of Roche to treat anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) in patients who have progressed on or are intolerant to Xalkori crizotinib. The NDA was under Priority Review, with a PDUFA date of March 4, 2016.

Genentech plans to launch the ALK inhibitor by year end at a monthly cost of about $12,500. The company has an assistance program to limit monthly co-pays to $25 for eligible patients. ...