6 April 2020 - Approval based on positive results from the Phase 3 ALTA-1L trial showing Alunbrig demonstrated superior overall and intracranial effectiveness over crizotinib in the first-line setting.
Takeda today announced that the European Commission extended the current marketing authorization of ALUNBRIG (brigatinib) to include use as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer previously not treated with an ALK inhibitor.
This decision follows a positive opinion from the CHMP on 27 February 2020.