Posted by Michael Wonder on 04 Aug 2017
FDA grants Genentech’s Alecensa priority review for initial treatment of people with ALK positive lung cancer
4 August 2017 - Genentech announced today that the U.S. FDA has accepted the company’s supplemental new drug application and granted priority review for Alecensa (alectinib) as an initial (first-line) treatment for people with anaplastic lymphoma kinase positive, locally advanced or metastatic non-small cell lung cancer as detected by an FDA-approved test.
The FDA will make a decision on approval by 30 November 2017.
This submission for Alecensa is based on results from the Phase III ALEX and Phase III J-ALEX studies. A priority review designation is granted to proposed medicines that, if approved, the FDA has determined to have the potential to provide a significant improvement in the safety or effectiveness of the treatment, prevention or diagnosis of a serious disease.
