publication date: Oct. 20, 2016
Regulatory Actions Genentech receives second Breakthrough Therapy Designation from FDA for Alecensa
GENENTECH, a member of the Roche Group, received a second Breakthrough Therapy Designation from FDA for its anaplastic lymphoma kinase inhibitor, Alecensa (alectinib). The latest BTD was granted for the treatment of adult patients with advanced ALK-positive non-small cell lung cancer who have not received prior treatment with an ALK inhibitor.
“The J-ALEX study that supports the second Breakthrough Designation for Alecensa showed superior efficacy versus the standard of care, crizotinib, in Japanese people with advanced ALK-positive disease,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “The decision by the FDA to grant a second Breakthrough Therapy Designation is recognition of the clinically meaningful improvement in efficacy and safety that Alecensa brings to the care of people with advanced ALK-positive lung cancer who have not received prior treatment with an ALK inhibitor.”
Alecensa received its first FDA BTD in June 2013 for people with ALK-positive NSCLC whose disease progressed on treatment with crizotinib.
Alecensa was granted accelerated approval in December 2015 for the treatment of ALK-positive NSCLC who have progressed on or are intolerant to crizotinib. ALEX, a global, randomized phase III study, is ongoing, comparing Alecensa to crizotinib as an initial (first-line) treatment for people with advanced NSCLC whose tumors were … Continue reading CCL Oct 2016 – Genentech receives second Breakthrough Therapy Designation from FDA for Alecensa
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