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CHMP Recommends European Approval of Takeda's Alunbrig for ALK-Positive NSCLC

NEW YORK – Takeda said on Monday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of brigatinib (Alunbrig) as a first-line monotherapy for ALK-positive advanced non-small cell lung cancer that has not been previously treated with an ALK inhibitor.

CHMP made the recommendation based on data from the Phase III ALTA-1L trial, which showed that after more than two years of follow-up, brigatinib reduced risk of intracranial disease progression or death by 69 percent and more than doubled the median progression-free survival over crizotinib (24 months versus 11 months). There are approximately 10,000 patients with ALK-Positive NSCLC in Europe.

"Because of the complex nature of ALK-positive NSCLC and the way in which the disease often spreads to the brain, it is essential for physicians to have treatment options that demonstrate both overall and intracranial effectiveness," Sanjay Popat, a consultant medical oncologist at the Royal Marsden NHS Foundation Trust and an investigator on the ALTA-1L trial, said in a statement. "In the ALTA-1L trial, brigatinib demonstrated significant responses in the brain and consistent overall efficacy compared to crizotinib. If approved by the EMA, brigatinib has the potential to become an important option for the first-line treatment of ALK-positive advanced NSCLC patients in Europe."

Last week, Takeda said that the US Food and Drug Administration accepted its application to expand the use of brigatinib to first-line, ALK-positive NSCLC, which was supported by data from the same trial.

ALTA-1 also showed that brigatinib's safety profile is in line with what has previously been seen in patients.