Takeda Pharmaceuticals has bagged approval for Alunbrig in the US as a treatment for a specific group of lung cancer patients.
The US Food and Drug Administration has given permission for the once-daily drug’s use as a second-line therapy for adults with non-small cell lung cancer (NSCLC) who also carry the anaplastic lymphoma kinase (ALK) mutation, which equates to around 5 percent of the total NSCLC population.
The indication was cleared under Accelerated Approval based on tumour response rate and duration of response seen in a mid-stage study, and so a full green light may be contingent upon verification and description of clinical benefit in a confirmatory trial, the firm noted.
Data from the Phase II trial showed that of patients who received the recommended dosing regimen of Alunbrig (brigatinib), 54 percent achieved a confirmed overall response as assessed by an investigator, while the median duration of response was found to be 11.1 months.
“In recent years, small molecule ALK inhibitors have revolutionised the treatment options for those with advanced ALK+ non-small cell lung cancer. Nevertheless, there is still a need for additional ALK inhibitors like brigatinib (Alunbrig), which have a manageable safety profile and may address mechanisms of clinical resistance to crizotinib, including progression in the central nervous system,” noted D Ross Camidge, director of thoracic oncology at the University of Colorado, commenting on the approval.
Alunbrig, which also carries Breakthrough status in the US, is a targeted cancer medicine discovered by ARIAD Pharmaceuticals, acquired by Takeda in February 2017.
The drug is also currently being assessed in a Phase III trial evaluating its potential in the first line setting, which would significantly expand its target population.