FDA Approves New Dosage for Rare Lung Cancer Drug

James Radke

The U.S. Food and Drug Administration (FDA) has approved a new dosage of Alunbrig (brigatinib) to treat patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.

Patients with this rare cancer can now opt to orally ingest a 180 mg tablet, as opposed to taking multiple 30 mg tablets.

The new formulation comes on the heels of the drug receiving accelerated approval for ALK+ NSLCL in April 2017, meaning that its full approval is subject to results from a larger confirmatory clinical trial.

Approximately 2-8% of patients with NSCLC have a rearrangement in the ALK gene. Patients with ALK+ NSCLC are difficult to treat and at present, 70% will develop brain metastases.

The approval of the 180 mg tablet was based on results of the Phase 2 ALTA trial showing that 53% of patients with locally advanced or metastatic ALK+ NSCLC who had progressed on crizotinib that were given a dose of 180 mg Alunbrig achieved a confirmed objective response (OR). Further, 67% of patients with measurable brain metastases who received 180 mg achieved a confirmed intracranial OR.

The recommended dosing regimen for Alunbrig is 90 mg per day for the first 7 days and if tolerated, the dose is then increased to 180 mg per day. At that dosing regimen, the most common adverse reactions (≥25%) with Alunbrig were nausea, diarrhea, fatigue, cough, and headache.

In a news release,  Mohammad Jahanzeb, M.D., Professor of Clinical Medicine, Hematology and Oncology at University of Miami's Miller School of Medicine said: “Today’s approval of the Alunbrig 180 mg tablets will reduce pill burden for patients taking Alunbrig for advanced ALK+ NSCLC. ”

Dr, Jahanzeb added, “As a physician, having a 180 mg tablet available for my patients may help them better manage their treatment schedule.”

“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.”

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