FDA grants accelerated approval for Alecensa (alectinib) to treat ALK-positive NSCLC- Genentech

Genentech 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 Xalkori (crizotinib). In the pivotal studies, alectinib shrank tumours in people with ALK+ 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 tumours that had spread to the brain or other parts of the central nervous system (CNS), alectinib shrank the CNS tumours in about 60% (CNS ORR of 61% [95% CI 46–74%]).

Possible serious side effects with alectinib include liver problems, lung problems, slow heartbeat, muscle pain, tenderness and weakness. The most common side effects of alectinib include tiredness, constipation and swelling in the hands, feet, ankles and eyelids.

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

Comment:. ALK gene mutations are present in about 5% of patients with NSCLC. In ALK+ NSCLC metastatic patients, the brain is a common place for the disease to spread.