FDA Approves New Alunbrig Tablet Strength
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.
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.