Roche's Alecensa gets FDA nod for NSCLC

FDA granted accelerated approval to Alecensa alectinib from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) to treat advanced non-small cell lung cancer in anaplastic lymphoma kinase (ALK)-positive patients who have progressed on or are intolerant to Xalkori crizotinib. The approval came well ahead of the ALK inhibitor's March 4, 2016, PDUFA date.

Genentech said it expects to launch Alecensa in the U.S. within two weeks. Spokesperson Andrew Villani told BioCentury the drug's monthly cost will be about $12,500. He said Genentech has an assistance program to limit monthly co-pays to $25 for eligible patients. ...