Takeda Announces FDA Approval of ALUNBRIG (brigatinib) 180 mg Tablets

Takeda Pharmaceutical Company Limited announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for ALUNBRIG® (brigatinib) 180 mg tablets. ALUNBRIG received Accelerated Approval from the FDA in April 2017 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. This indication is approved under Accelerated Approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The recommended dosing regimen for ALUNBRIG is 90 mg orally once daily for the first seven days and if tolerated, the dose is then increased to 180 mg orally once daily.

“Initially ALUNBRIG was only available in 30 mg tablets. This meant that patients who were taking ALUNBRIG had to take three pills (to equal 90 mg) daily or six pills (to equal 180 mg) daily,” said Ryan Cohlhepp, PharmD, Vice President, U.S. Commercial, Takeda Oncology. “With the approval of a 180 mg tablet, ALUNBRIG has become the only ALK inhibitor available as a one tablet per day dose that can be taken with or without food.”

“Today’s approval of the ALUNBRIG 180 mg tablets will reduce pill burden for patients taking ALUNBRIG for advanced ALK+ NSCLC,” said Mohammad Jahanzeb, M.D., F.A.C.P, Professor of Clinical Medicine, Hematology and Oncology at University of Miami’s Miller School of Medicine. “As a physician, having a 180 mg tablet available for my patients may help them better manage their treatment schedule.”

The recommended dosing regimen was supported by the results of the pivotal Phase 2 ALTA (ALK in Lung Cancer Trial of AP26113) trial. This two-arm, open-label, multicenter trial of 222 patients with locally advanced or metastatic ALK+ NSCLC who had progressed on crizotinib found that, of the patients who received the recommended dosing regimen (90→180 mg), 53 percent achieved a confirmed objective response (OR) as assessed by an Independent Review Committee (IRC). Additionally, 67 percent of patients with measurable brain metastases who received this dosing regimen achieved a confirmed intracranial OR by IRC assessment. In ALTA, serious adverse reactions occurred in 38% of patients in the 90 mg group and 40% of patients in the 90→180 mg group. Overall, the most common serious adverse reactions were pneumonia and interstitial lung disease (ILD)/pneumonitis. Fatal adverse reactions occurred in 3.7% of patients and consisted of pneumonia (2 patients), sudden death, dyspnea, respiratory failure, pulmonary embolism, bacterial meningitis and urosepsis (1 patient each). At the recommended dosing regimen, the most common adverse reactions (≥25%) with ALUNBRIG were nausea, diarrhea, fatigue, cough, and headache. The ALTA trial is ongoing and updated data will be presented at the 18th World Conference on Lung Cancer of the International Association for the Study of Lung Cancer, October 15-18, in Yokohama, Japan.