The Japanese medicines regulator has granted a new approval for Takeda Pharmaceutical (TYO: 4502) to market its next-generation tyrosine kinase inhibitor (TKI) Alunbrig (brigatinib).
The approval covers use of the product as a first and second-line therapy for the treatment of people with ALK-positive non-small cell lung cancer (NSCLC) which is unresectable, advanced or recurrent.
First approved in the USA in 2017, Alunbrig is a potent and selective TKI that was designed to target anaplastic lymphoma kinase (ALK) molecular alterations.
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