U.S. Food and Drug Administration (FDA) grants accelerated approval to Alecensa (alectinib)

December 11, 2015

In two important studies, Alecensa (alectinib) reduced the size of tumors in NSCLC patients with genetic alterations in ALK who progressed while being treated with crizotinib.  Alecensa binds to and inhibits ALK which can be genetically altered in some lung cancers.  Alecensa can also inhibit some mutant forms of ALK which are resistant to crizotinib and other small molecule ALK kinase inhibitors.  The inhibition caused by Alecensa disrupts ALK hyper-activation and results in shrinkage of  tumors.  The first study was a phase II single-arm, open-label trial evaluating 87 patients. The second study was a phase I/II global, single-arm, open-label trial evaluating 138 patients.  In these studies, response rates of 38 percent and 44 percent, respectively, were observed.  Responses were durable in both studies with median durations of 7.5 months and 11.2 months, respectively.  In addition, in patients with measurable brain metastases, the response rate was 61% and median duration of response was 9.1 months.  Alectinib is the second drug approved for ALK-positive patients who have failed crizotinib.