Takeda Korea said Wednesday that the Ministry of Food and Drug Safety has approved Alunbrig (Ingredient: brigatinib), its anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer treatment.
Alunbrig is a treatment for patients with ALK-positive or metastatic non-small cell lung cancer who had previously received crizotinib as a treatment. The drug received approval from the U.S. Food and Drug Administration in April 2017 and by the European Commission in November 2018.
“Alunbrig was found to have a median progressive median survival (PFS) time of 16.7 months as a treatment for patients with ALK-positive or metastatic non-small cell lung cancer that have failed to their treatment with crizotinib,” said Lee Ji-hyung, director of Takeda Korea’s specialty care division. “We are delighted to deliver an effective treatment option for patients who are suffering from relapse or metastasize localized ALK-positive non-small-cell lung cancer.”
The ministry approved the sales of the product based on the ALTA study, an open-label, multicenter, phase 2 study on Alunbrig in 222 patients with locally advanced or metastatic ALK-positive non-small cell lung cancer who received crizotinib
The primary efficacy outcome measures were the objective response rates assessed by independent review committees.
The objective response rate of the patients treated with the recommended dose was 53 percent, while the duration of response was 15.7 months. The company also found the safety profile to be generally good.
The median PFS of patients treated with Alunbrig after crizotinib treatment failure was 16.7 months.
<© Korea Biomedical Review, All rights reserved.>