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Brigatinib Granted Accelerated Approval for NSCLC

doi: 10.1097/01.COT.0000520704.66293.70
FDA Updates

Brigatinib has received Accelerated Approval from the FDA for the treatment of patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.

Brigatinib, which previously received Breakthrough Therapy Designation, is a once-daily oral therapy that may be taken with or without food.

The FDA approval of brigatinib was primarily based on results from the pivotal phase II ALTA (ALK in Lung Cancer Trial of AP26113) trial of brigatinib in adults. This ongoing, two-arm, open-label, multicenter trial enrolled 222 patients with locally advanced or metastatic ALK+ NSCLC who had progressed on crizotinib. Patients received either 90 mg of brigatinib once daily (n=112) or 180 mg once daily following a 7-day lead-in of 90 mg once daily (n=110). The major efficacy outcome measure was confirmed overall response rate (ORR) according to RECIST v1.1 as evaluated by an Independent Review Committee (IRC). Additional efficacy outcome measures included investigator-assessed ORR, duration of response (DOR), intracranial ORR, and intracranial DOR.

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