Marketing approval received in Japan for Alunbrig in the treatment of ALK fusion gene-positive unresectable advanced or recurrent non-small cell lung cancer.- Takeda

Takeda Pharmaceutical Company Limited announced that it has obtained approval from the Japanese Ministry of Health, Labour and Welfare to manufacture and market Alunbrig Tablets 30 mg, 90 mg" (brigatinib, development code: AP26113) as a first and second-line therapy for the treatment of patients with unresectable, advanced or recurrent ALK fusion gene-positive non-small cell lung cancer (ALK+ NSCLC). The approval is mainly based on the results of Brigatinib-2001 (J-ALTA), a Phase II clinical trial conducted in Japan involving 72 ALK+ patients with unresectable advanced or recurrent NSCLC who progressed after treatment with an ALK tyrosine kinase inhibitor, as well as the AP26113-13-301 (ALTA-1L) global Phase III clinical trial focused on ALK+ patients with unresectable advanced or recurrent NSCLC who had not been treated with an ALK tyrosine kinase inhibitor.