www.fdanews.com/articles/196586-takedas-alunbrig-receives-expanded-eu-approval-for-lung-cancer
Takeda’s Alunbrig Receives Expanded EU Approval for Lung Cancer
April 9, 2020
The European Commission authorized Takeda’s Alunbrig (brigatinib) as a first-line treatment for adults with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) not previously treated with an ALK inhibitor.
The approval was based on positive results from an ongoing phase 3 trial of Alunbrig compared to crizotinib.
The FDA granted Alunbrig accelerated approval in April 2017 for patients with ALK+ NLCSC whose disease has progressed or who are intolerant to crizotinib.