EU approves Takeda's TKI inhibitor ALUNBRIG as a first-line treatment for ALK-positive non-small cell lung cancer patients

Takeda Pharmaceuticals announced that the European Commission (EC) has expanded its marketing authority for tyrosine kinase inhibitors (TKI) ALUNBRIG (brigatinib) as a single therapy for adult patients with ALK-positive advanced non-small cell lung cancer (NSCLC) who have not previously been treated with metastatic lymphoma kinase (ALK) inhibitorsThe decision is based on the positive views of the Human Drug Commission (CHMP) on 27 February 2020Professor Sanjay Popat, medical adviser to the royal Marsden NHS Foundation Trust,, said: "ALK-positive NSCLC patients, particularly those with brain metastasis, are in urgent need of new treatmentsALUNBRIG demonstrated the obvious superiority of crizotinib in patients with brain metastasis, and this approval will meet the needs of ALK-positive NSCLC patientsthis approval is based on the results of the ALTA-1L Phase 3 trial, which assessed the safety and efficacy of ALUNBRIG compared to a patient with ALK-positive late-stage or metastatic NSCLC that was not treated with ALK inhibitorsThe results showed that after more than two years of follow-up, ALUNBRIG reduced the risk of intracranial disease progression or death in brain metastasis patients by 69%And the median progression-free survival (PFS) of ALUNBRIG was more than twice as long as the amount of cintotrini, at 29.4 months and 9.2 months, respectivelyALUNBRIG has been approved in more than 40 countries, including the United States, Canada and the European Union, for ALK-positive metastatic non-small cell lung cancer patients with progression of the disease after the treatment of keretininib