(Reuters) – Japan’s Takeda Pharmaceutical Co Ltd said on Friday that the U.S. Food and Drug Administration approved its lung cancer drug, almost three months after the company acquired the drug’s developer, Ariad Pharmaceuticals Inc.
The drug, Alunbrig, is approved as a second-line treatment for patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer, who have progressed on or are intolerant to Pfizer’s crizotinib, the standard initial treatment for the disease.
Alunbrig was approved under the FDA’s accelerated approval program, which allows for quicker approval of drugs that fill an unmet medical need. When a drug wins accelerated approval, the company must provide further evidence of its benefit, failing which the approval can be revoked.
Takeda in mid-February completed its acquisition of Ariad for $5.20 billion, undertaken to beef up its oncology pipeline.
(Reporting by Sruthi Shankar and Divya Grover in Bengaluru; Editing by Leslie Adler)