Genentech's alectinib granted priority review by FDA for non-small-cell lung cancer

Genentech, a unit of Swiss pharma major Roche (SIX: ROG), has been granted priority review by the US Food and Drug Administration for its alectinib for ALK-positive, locally advanced or metastatic non-small-cell lung cancer.

The FDA is expected to issue a final decision on whether to approve the investigational anaplastic lymphoma kinase inhibitor by March 4, 2016.

Sandra Horning, chief medical officer of Roche, said that alectinib was granted this priority review based on two studies, which looked at the efficacy and safety of the drug in patients with ALK-positive NSCLC whose tumors progressed on Pfizer’s (NYSE: PFE) Xalkori (crizotinib). Roche showed data from its Phase II studies earlier this year that illustrated alectinib brought about tumor shrinkage in around half of all treated patients. The therapy was also associated with overall response rates of 68.8% and 57.1% in the two studies in patients whose disease had already spread to the central nervous system. Patients who experienced a response continued to respond to the drug for a median of 7.5 months and 11.2 months.