The Ministry of Food and Drug Safety has approved Takeda Korea’s Alunbrig (ingredient: brigatinib) as the primary treatment for anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer on Thursday.

Alunbrig can be used on ALK-positive non-small cell lung cancer patients who have no history of receiving conventional primary ALK inhibitors with the recently expanded indication.

Takeda Korea’s anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer drug Alunbrig won a regulatory approval as a first-line therapy on Thursday. (Takeda)

The ministry approved the drug based on a second interim analysis of the ALTA-1L clinical trial on 275 patients with ALK-positive locally advanced or metastatic non-small cell lung cancer who had not been treated with ALK inhibitors.

According to the study result observed up to June 2019, the cohort that received Alunbrig had improved the risk of disease progression or death by about 51 percent compared to the crizotinib group. Alunbrig has been found to significantly delay the time worsening the patient’s global health score and quality of life.

At the beginning of the study, the intracranial overall response rate of the patients diagnosed with metastatic brain tumors with a diameter of 10 millimeters or larger was 78 percent in Alunbrig, and 26 percent in the Crizotinib group.

Alunbrig also reduced the risk of progression or death by about 69 percent in all patients with a metastatic brain tumor.

“Alunbrig showed excellent clinical efficacy regardless of brain metastasis in ALK-positive non-small cell lung cancer patients even in the second interim analysis,” Professor Ahn Myung Ju of the Department of Hematology and Oncology at Samsung Medical Center said.

“Alunbrig won regulatory approval as a first-line treatment for ALK-positive non-small cell lung cancer in the United States and Europe in the first half of 2020, being recognized for its value and efficacy,” said Kim Jeong-hun, the head of Takeda Korea’s anticancer drug division. “With the expanded indication, Takeda Korea could provide an option and resolve the demand of ALK-positive non-small cell lung cancer patients who has to be treated with the primary therapy.”

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