FDA Approves New Treatment Option for Specific Type of Lung Cancer

December 11th, 2015

On December 11, 2015, the FDA granted accelerated approval to Alecensa® (alectinib) for the treatment of people with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.

The indication for Alecensa is approved under accelerated approval based on tumor response rate and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

News in brief

• Accelerated approval allows conditional approval of a medicine that fills an unmet medical need for a serious condition based on early evidence suggesting clinical benefit
• Alecensa is Genentech’s third FDA-approved medicine for lung cancer
• Alecensa is being studied for use as an initial (first-line) treatment for people with advanced ALK-positive NSCLC in the Phase III ALEX study, which is part of the company’s commitment to convert the current accelerated approval to a full approval