Posted by Michael Wonder on 24 Sep 2018
Takeda receives positive CHMP opinion recommending Alunbrig (brigatinib) for the treatment of ALK+ non-small cell lung cancer in patients previously treated with crizotinib
21 September 2018 - 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.
Takeda 450 today announced that the EMA's 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 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 approves Alunbrig, it will become the only ALK inhibitor available in the European Union as a one tablet per day dose that can be taken with or without food.
