Takeda’s Alunbrig outclasses Xalkori to secure EU approval in ALK+ advanced non-small cell lung cancer

pharmafile | April 7, 2020 | News story | Manufacturing and Production, Sales and Marketing |  Alunbrig, Europe, Takeda, pharma 

The European Commission has ruled to expand the current approved indication of Takeda’s Alunbrig (brigatinib), authorising the drug as a monotherapy in the treatment of anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) in adult patients who have not received an ALK inhibitor.

The approval comes on the heels of the drug’s receipt of a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in February. It was secured on the back of Phase 3 data demonstrating its efficacy compared to Xalkori (crizotinib).

In the study, Alunbrig was shown to reduce the risk of intracranial disease progression or death by 69% in patients with brain metastases at baseline after two years of follow-up according to a blinded independent review committee (BIRC), and by 76% by study investigators.

Furthermore, the therapy showed consistent overall efficacy in the intent to treat population, doubling the median progression-free survival (PFS) of Xalkori at 24 months compared to 11 months according to the BIRC, and 29.4 months compared to 9.2 months according to study investigators.

“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,” remarked Professor Sanjay Popat, Consultant Medical Oncologist at the 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.”

Matt Fellows