EU approves Alunbrig for ALK+ non-small cell lung cancer.- Takeda Pharmaceutical.

Takeda Pharmaceutical announced that the European Commission has granted marketing authorization for 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. The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on September 20, 2018.

The European Commission�s approval is based on data from the global Phase II ALTA trial, in which patients were randomized to receive one of two dosing regimens of Alunbrig : 90 mg once daily (n=112) or the recommended dosing regimen of 180 mg once daily with seven-day lead-in at 90 mg once daily (n=110). Results showed that of the patients who received the recommended dosing regimen, 56 percent achieved an objective response rate (ORR), and the median duration of response (DOR) was 15.7 months as assessed by independent review committee (IRC). Alunbrig demonstrated a median progression-free survival (PFS) of 16.7 months by IRC assessment and overall survival of 34.1 months for patients with locally advanced or metastatic ALK+ NSCLC who had progressed on crizotinib. Some of the most common adverse reactions (at least 25%) reported in patients treated with Alunbrig at the recommended 180 mg dosing regimen were increased aspartate aminotransferase (AST), hyperglycemia, hyperinsulinemia and anemia.