Takeda wins approval for new once daily dose of Alunbrig

Takeda Pharmaceutical today announced that the US Food and Drug Administration has approved the supplemental new drug application for Alunbrig (brigatinib).

The drug was given accelerated approval status in April 2017 for the treatment of certain lung cancer patients, and continued approval may be contingent on confirmatory data.

“Initially Alunbrig was only available in 30mg tablets,” said Ryan Cohlhepp, VP of commercial at Takeda. “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.”

The recommended dosing regimen was supported by the results of the pivotal Phase II ALTA trial.