The FDA conditionally approved alectinib (brand name Alecensa) on December 11, 2015 as a second line treatment. This approval came less than 3 months after the FDA application was filed.
The approval was based on results from two single-arm clinical trials. Both trials were limited to patients whose cancer had progressed on crizotinib (Xalkori). In the first study, 38 percent of participants experienced a partial shrinkage of their NSCLC tumors, an effect that lasted for an average of 7.5 months. In the second study, 44 percent of participants experienced a partial shrinkage of their NSCLC tumors, lasting for an average of 11.2 months.
Sixty-one percent of participants in the two trials who had measurable brain metastases experienced a complete or partial reduction in their brain tumors, lasting an average of 9.1 months
The most common adverse reactions were fatigue, constipation, edema, and myalgia.
Alecensa will be available to people in the United States within two weeks. For those who qualify, Genentech plans to offer patient assistance programs for people taking Alecensa through Genentech Access Solutions. Alecensa will cost $12,500 per month.