The FDA announced Friday that it granted accelerated approval for Takeda's Alunbrig (brigatinib) for the treatment of patients with metastatic ALK-positive non-small-cell lung cancer (NSCLC) who have progressed on or are intolerant to Pfizer's Xalkori (crizotinib). Takeda gained Alunbrig via its $5.2-billion acquisition of Ariad Pharmaceuticals, which was finalised in February.
Approval of Alunbrig was supported by data from the ongoing Phase II ALTA trial. The study enrolled 222 patients with locally advanced or metastatic ALK-positive NSCLC who had progressed on Xalkori. Patients were randomised to Alunbrig orally, either 90 mg once daily or 180 mg once daily following a seven-day lead-in at 90 mg once daily.
Results as evaluated by an independent review committee demonstrated that overall response rate (ORR) was 48 percent in the 90-mg arm and 53 percent in the 180-mg arm. After a median follow-up of eight months, median duration of response was 13.8 months in both groups. Among patients with measurable brain metastases at baseline, intracranial ORR was 42 percent in the 90-mg arm and 67 percent in the 180-mg arm.
The FDA previously granted Alunbrig a breakthrough therapy designation for the treatment of patients with ALK-positive NSCLC whose tumours are resistant to Xalkori. The agency also granted Alunbrig orphan drug status for the treatment of ALK-positive NSCLC, ROS1-positive and EGFR-positive NSCLC. Meanwhile, a marketing authorisation application for the drug was submitted to the European Medicines Agency in February for adults with ALK-positive NSCLC who were previously treated with Xalkori.
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