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Expanded EU approval for Takeda’s Alunbrig

European regulators have expanded the scope of Alunbrig (brigatinib) to include its use as a monotherapy for the treatment of adults with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) in the first-line setting.

The approval is based on results from the Phase III ALTA-1L trial, which showed that the drug demonstrated superiority in this treatment setting compared to crizotinib with significant anti-tumor activity observed in patients with baseline brain metastases.

This expanded indication provides the around 10,000 people living with ALK+ NSCLC in Europe an additional first-line treatment option that has demonstrated strong overall and intracranial efficacy, the firm noted.

“Patients with ALK+ NSCLC, particularly those who have developed brain metastases, have been in need of additional treatment options that are proven effective in the first-line setting,” said Professor Sanjay Popat, consultant medical oncologist, Royal Marsden NHS Foundation Trust.

“As brigatinib has shown superiority compared to crizotinib in this setting, including in patients whose disease has spread to the brain, this approval is an important advancement for these patients and gives physicians in the European Union another choice when addressing the needs of ALK+ NSCLC patients.”