FDA grants Genentech’s Alecensa Priority Review

Designation given for initial treatment of people with ALK-positive lung cancer.

Genentech has announced that the FDA has accepted the company’s supplemental New Drug Application (sNDA) and granted Priority Review for Alecensa (alectinib) as an initial (first-line) treatment for people with anaplastic lymphoma kinase (ALK)-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. The FDA will make a decision on approval by 30 November 2017.

"Phase III results showed Alecensa reduced the risk of disease worsening by more than half compared to the current standard of care and lowered the risk of tumours spreading to or growing in the brain by more than 80%," said Sandra Horning, chief medical officer and head of Global Product Development. "We are working closely with the FDA to bring this medicine as an initial treatment for people with ALK-positive NSCLC as soon as possible."

This sNDA submission for Alecensa is based on results from the Phase III ALEX and Phase III J-ALEX studies.

Alecensa received Breakthrough Therapy Designation from the FDA in September 2016 for the treatment of adults with advanced ALK-positive NSCLC who have not received prior treatment with an ALK inhibitor, and was granted on the basis of the Phase III J-ALEX trial.

Alecensa was granted accelerated approval by the FDA in December 2015 for the treatment of people with ALK-positive metastatic NSCLC who have progressed on or are intolerant to crizotinib. The ALEX study is part of the company’s commitment in the US to convert the current accelerated approval of Alecensa in people with ALK-positive, metastatic NSCLC who have progressed on or are intolerant to crizotinib to a full approval as an initial treatment.