30 July 2018 - Takeda Canada has received Notice of Compliance with conditions approval from Health Canada for Alunbrig (brigatinib) indicated as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase-positive metastatic non–small cell lung cancer who have progressed on or who were intolerant to an ALK inhibitor (crizotinib).
Alunbrig is a new ALK inhibitor that meets the needs of patients with advanced lung cancer who urgently require more alternatives to the standard of care – crizotinib – because they are intolerant or the medicine has stopped working to slow the progression of this devastating, terminal disease.
The ALTA (ALK in Lung Cancer Trial of AP26113) trial demonstrated clinically meaningful efficacy, with the majority of patients who received the recommended dosage achieving an objective response rate (ORR) and median progression free survival of greater than one year. The study also showed an intracranial ORR in the majority of patients with measurable brain metastases.