Japan's Chugai Pharmaceutical Co., Ltd. (CHGCF.PK) announced Tuesday that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation or BTD for the first-line treatment of ALK positive non-small cell lung cancer to Alecensa, a highly selective ALK inhibitor.
Alecensa, created by Chugai, is approved in Japan and in the United States, and filed in Europe by Genentech, a member of the Roche Group (RHHBY).
This second designation for Alecensa is based on the J-ALEX study, conducted by Chugai, which is an open-label, randomized phase III study that compares the efficacy and safety between Alecensa and crizotinib.
Chugai noted that the latest is the fourth Breakthrough Therapy Designation for the company originated drugs following Alecensa (ALK positive, metastatic NSCLC in patients who have progressed on or those who are intolerant to crizotinib), Actemra (systemic sclerosis), and emicizumab (prophylactic treatment for 12 years or older patients with hemophilia A with factor VIII inhibitors).
Chugai said it will collaborate with Roche and Genentech to receive approval for the early use of Alecensa in a number of countries around the world.
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