Posted by Michael Wonder on 24 Feb 2020
Takeda announces U.S. FDA grants priority review for supplemental new drug application for Alunbrig (brigatinib) as a first-line treatment for ALK+ metastatic non-small cell lung cancer
25 February 2020 - Prescription Drug User Fee Act target action date set for 23 June 2020.
Takeda today announced that the U.S. FDA has granted priority review for the company’s supplemental new drug application to expand the use of Alunbrig (brigatinib) as a first-line treatment for patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
The application for Alunbrig as a first-line treatment is based on results from the Phase 3 ALTA-1L trial, which is evaluating the safety and efficacy of Alunbrig in patients with ALK+ locally advanced or metastatic NSCLC who have not received prior treatment with an ALK inhibitor compared to that of crizotinib in the same population.
