US FDA approves Takeda’s sNDA for new dose regimen of Alunbrig 180mg tablets


The US Food and Drug Administration (FDA) has approved Takeda Pharmaceutical Company’s supplemental new drug application (sNDA) for 180mg Alunbrig tablets to treat patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC).

NSCLC is the most common type of lung cancer and genetic studies have revealed that chromosomal rearrangements in anaplastic lymphoma kinase (ALK) is the major cause.

In April, the FDA granted accelerated approval for Alunbrig to treat the ALK+ NSCLC patients who have progressed on or are intolerant to crizotinib.

The current indication is approved under accelerated approval based on tumour response rate and the duration of response.

The recommended dosing regimen for the oral Takeda treatment is 90mg once daily for the first week and, if tolerated, the dose can then be increased to 180mg once daily.

Takeda Oncology US Commercial vice-president Ryan Cohlhepp said: “Initially, Alunbrig was only available in 30mg tablets. This meant that patients who were taking Alunbrig had to take three pills (to equal 90mg) daily, or six pills (to equal 180mg) daily.

“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.”

"Alunbrig has become the only ALK inhibitor available as a one tablet per day dose that can be taken with or without food."

The approval of the recommended dosing regimen was based on the results obtained from the pivotal, two-arm, open-label, multicentre, Phase II ALTA trial.

The experiment involved 222 patients with locally advanced or metastatic ALK+ NSCLC who had progressed on crizotinib.

The medicine received breakthrough therapy designation from the US agency for the treatment of patients with ALK+ NSCLC whose tumours are resistant to crizotinib.

It was also granted orphan drug designation for the treatment of ALK+ NSCLC, ROS1+, and EGFR+ NSCLC.


Image: Human anaplastic lymphoma kinase in complex with crizotinib. Photo: courtesy of A2-33.