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– Opinion Based on Pivotal Phase 2 ALTA Trial, in which ALUNBRIG Demonstrated an Objective Response Rate of 56% and Longest Reported Median Progression-Free Survival of 16.7 months in the Post-Crizotinib Setting – CAMBRIDGE, Mass. & OSAKA, Japan-Sunday 23 September 2018 [ AETOS Wire ] (BUSINESS WIRE) -- Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the full approval of ALUNBRIG®(brigatinib) as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib. ALUNBRIG is a tyrosine kinase inhibitor (TKI) designed to target and inhibit the ALK mutation in NSCLC. Approximately three to five percent of NSCLC patients globally have the ALK mutation. If the CHMP opinion is affirmed, and the European Commission approve ... Read more »
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