FDA Approves New Alunbrig Tablet Strength

Alunbrig is approved for ALK+ non-small cell lung cancer
Alunbrig is approved for ALK+ non-small cell lung cancer

Takeda announced that the Food and Drug Administration (FDA) has approved a new 180mg strength tablet of Alunbrig (brigatinib). 

In April 2017, the FDA granted accelerated approval of Alunbrig, a kinase inhibitor, 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. 

“With the approval of a 180mg tablet, Alunbrig has become the only ALK inhibitor available as a one tablet per day dose that can be taken with or without food," said Ryan Cohlhepp, PharmD, Vice President, U.S. Commercial, Takeda Oncology. 

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The dosing regimen was supported by data from the Phase 2, open-label, 2-arm, multicenter ALTA trial (n=222). About half of the patients (53%) with locally advanced or metastatic ALK+ NSCLC who had progressed on crizotinib who received the recommended dosing regimen (90mg once daily for 7 days then 180mg once daily, if tolerated) had a confirmed objective response (OR). Moreover, 67% of patients with measurable brain metastases who followed the dosing regimen achieved a confirmed intracranial OR. 

Nausea, diarrhea, fatigue, cough, and headache were reported as the most common adverse reactions (≥25%) at the recommended dosing regimen. 

Alunbrig is already approved in 30mg and 90mg strength tablets, but currently only the 30mg strength is available.

For more information call (844) 217-6468 or visit Alunbrig.com.