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European approval for Takeda's Alunbrig in ALK+ advanced non-small cell lung cancer

Published on 27/11/18 at 05:14pm

Takeda’s Alunbrig (brigatinib) has been granted marketing approval by the European Commission as a monotherapy to treat anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) in adult patients previously treated with crizotinib, the firm has revealed.

The decision follows a positive opinion by the Committee for Medicinal Products for Human Use (CHMP), and was based on Phase 2 data which demonstrated that 56% of patients taking Alunbrig achieved an objective response rate (ORR). The drug also displayed a median duration of response of 15.7 months, a median progression-free survival of 16.7 months, and an overall survival of 34.1 months, as assessed by an independent review committee.

“The introduction of targeted therapies has greatly improved the treatment of ALK+ NSCLC, yet for the approximately 70% of patients who progress on crizotinib with brain metastases, additional therapeutic options are needed,” said Dr Enriqueta Felip, Head of the Thoracic Oncology Unit, Oncology Department at Vall d’Hebron University Hospital in Barcelona. “Data from the ALTA trial investigating Alunbrig showed sustained systemic and intracranial efficacy results and a manageable safety profile, leading to the longest progression-free survival and overall survival reported in this setting. This approval gives physicians in the European Union another choice in addressing ALK+ NSCLC patients previously treated with crizotinib.”

Dr Jesús Gómez-Navarro, Vice President, Head of Oncology Clinical Research and Development at Takeda, also commented on the announcement: “The European Commission’s decision to approve ALUNBRIG for patients with ALK+ NSCLC is a significant advancement for European patients impacted by this life-threatening disease. This is the first time a median progression-free survival of over 16 months as assessed by an independent review committee and median overall survival of 34 months have been reported in the post-crizotinib setting, which highlights the strength of the ALTA trial data. The authorisation of Alunbrig in the EU speaks to our ongoing commitment to developing innovative solutions to improve the lives of the approximately 40,000 patients diagnosed with this disease worldwide each year.”

Matt Fellows

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