28 November 2018 - - The European Commission granted marketing authorization for Alunbrig (brigatinib) as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib, Japanese pharmaceutical company Takeda Pharmaceutical Company Ltd. (TSX: 4502) said.

The decision follows a positive opinion from the Committee for Medicinal Products for Human Use on September 20, 2018.

The European Commission's approval is based on data from the global Phase 2 ALTA trial, in which patients were randomized to receive one of two dosing regimens of Alunbrig: 90 mg once daily (n=112) or the recommended dosing regimen of 180 mg once daily with seven-day lead-in at 90 mg once daily (n=110).

Results showed that of the patients who received the recommended dosing regimen, 56 % achieved an objective response rate, and the median duration of response was 15.7 months as assessed by independent review committee.

Alunbrig demonstrated a median progression-free survival of 16.7 months by IRC assessment and overall survival of 34.1 months for patients with locally advanced or metastatic ALK+ NSCLC who had progressed on crizotinib.

The most common adverse reactions reported in patients treated with ALUNBRIG at the recommended 180 mg dosing regimen were increased aspartate aminotransferase, hyperglycemia, hyperinsulinemia, anemia, increased creatine phosphokinase, nausea, increased lipase, decreased lymphocyte count, increased alanine aminotransferase, diarrhea, increased amylase, fatigue, cough, headache, increased alkaline phosphatase, hypophosphatemia, increased abnormal activated partial thromboplastin time, rash, vomiting, dyspnea, hypertension, decreased blood cell count, myalgia, and peripheral neuropathy.
The most common serious adverse reactions (≥ 2 %) reported in patients treated with Alunbrig at the recommended dosing regimen other than events related to neoplasm progression were pneumonitis, pneumonia, and dyspnea.

This decision by the European Commission means that Alunbrig is now approved for marketing of this indication in the 28 member states of the European Union, and applicable in Norway, Liechtenstein and Iceland.