FDA Grants Alectinib Priority Review for ALK‑Positive Lung Cancer
Genentech announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) and granted Priority Review for alectinib, an oral investigational anaplastic lymphoma kinase (ALK) inhibitor, for the treatment of people with ALK-positive, locally advanced or metastatic non–small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib (Xalkori). Alectinib was granted Breakthrough Therapy designation by the FDA in June 2013 for people with ALK-positive NSCLC whose disease progressed on crizotinib.
Alectinib was granted Priority Review based on the results from two phase II studies (NP28761 and NP28673) recently presented at the 2015 ASCO Annual Meeting showing that the drug shrank tumors in patients with ALK-positive NSCLC that had progressed on crizotinib.
Treatment with alectinib resulted in objective response rates of 47.8% and 50% in the NP28761 and NP28673 trials, respectively. Activity was also observed in the central nervous system (CNS) and in patients with brain or CNS metastases. The median duration of response was 7.5 and 11.2 months, respectively. The safety profile was consistent with that observed in previous studies.
The FDA will make a decision on approval by March 4, 2016.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
