Following a positive opinion from the European Medicines Agency’s advisory body the CHMP in late February, Japanese pharma giant Takeda (TYO: 4502) today announced that the European Commission has extended the current marketing authorization of Alunbrig (brigatinib).
The added indication is to include use as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) in the first-line setting, noted Takeda, whose shares closed up 5.5% at 3,342 yen in today’s Tokyo trading.
The first-line indication is under priority review in the USA. As a frontline drug for lung cancer Alunbrig will compete with Novartis’ (NOVN: VX) Zykadia (ceritinib) and Roche’s (ROG: SIX) Alecensa (alectinib).
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