Roche’s Alecensa receives second FDA Breakthrough Therapy Designation

pharmafile | October 4, 2016 | News story | Manufacturing and Production |  ALK+, Alecensa, FDA, Roche, alk, crizotinib 

Alecensa has been designated as a breakthrough therapy, which will speed up the process towards FDA approval, should clinical trials data be positive. Alecensa is a treatment for adult patients with advanced ALK positive non-small cell lung cancer (NSCLC). The BTA was given after clinical trial data from a Phase III trial.

This is the second of such processes to speed up Alecensa’s approval, as previously it had received accelerated approval by the FDA in December 2015 for treatment of people with NSCLC who have not responded to treatment with crizotinib.

The approval was granted on the back of evidence generated through Phase III trial, named J-ALEX. The J-ALEX study, conducted by Chugai, is an open-label, randomized study that compared the efficacy and safety of Alecensa to crizotinib in Japanese people. The J-ALEX study enrolled 207 people with ALK-positive, advanced or recurrent NSCLC who had not been previously treated with an ALK inhibitor. People were randomized to the Alecensa group or the crizotinib group in a one-to-one ratio. Results included that Alecensa reduced the risk of disease worsening or death (progression free survival, PFS) by 66 percent compared to crizotinib.

Ben Hargreaves