Genentech, a South San Francisco-based member of the Roche Group, has announced that 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.
In the pivotal studies, Alecensa shrank tumors in up to 44% of people with ALK-positive NSCLC who progressed on crizotinib (objective response rate [ORR] of 38% [95% CI 28-49] and 44% [95% CI 36-53]). In a subset of people with tumors that spread to the brain or other parts of the central nervous system (CNS), Alecensa shrank CNS tumors in about 60% of people (CNS ORR of 61% [95% CI 46-74]).
“Alecensa is now approved as a new option for people with ALK-positive NSCLC who progress on or are intolerant to crizotinib,” said Sandra Horning, M.D., chief medical officer and head of global product development. “Sixty percent of people enrolled in our studies had tumors that had spread to their central nervous systems, and Alecensa shrank tumors in many people in a subset of patients with CNS disease.”
Possible serious side effects with Alecensa include liver problems, lung problems, slow heartbeat, muscle pain, tenderness and weakness. The most common side effects of Alecensa include tiredness, constipation and swelling in the hands, feet, ankles and eyelids.
The FDA’s Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious condition based on early evidence suggesting clinical benefit. The indication for Alecensa is approved under Accelerated Approval based on tumor response rate and duration of response (DOR). Continued approval for that indication may be contingent upon verification and description of clinical benefit in confirmatory trials.