Posted by Michael Wonder on 04 Oct 2016
US FDA grants breakthrough therapy designation for Roche's Alecensa (alectinib) for first-line treatment of people with ALK-positive NSCLC
4 October 2016 - This second Alecensa breakthrough therapy designation granted is based on phase 3 J-ALEX study.
Roche announced today that it has received a second breakthrough therapy designation from the U.S. FDA for its ALK inhibitor, Alecensa (alectinib).
The latest breakthrough therapy designation was granted for the treatment of adult patients with advanced anaplastic lymphoma kinase (ALK) positive non-small-cell lung cancer who have not received prior treatment with an ALK inhibitor.
