Positive CHMP approval for Takeda's Alunbrig in ALK advanced non-small lung cancer

The decision was based on Phase 3 comparing Alunbrig to crizotinib in the same indication. The findings for Alunbrig showed a 69% reduction in risk of intracranial disease progression or death in patients with brain metastases according to a blinded independent review committee, and a 76% reduction according to investigators. The drug also demonstrated a median progression-free survival of 24 months, more than double the 11 months presented by crizotinib. Because of the complex nature of ALK+ 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,” explained Professor Sanjay Popat, Consultant Medical Oncologist, Royal Marsden NHS Foundation Trust. “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+ advanced NSCLC patients in Europe.