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Bayer's Vitravki poised to become first tumour-agnostic therapy in EU following CHMP recommendation

Published on 30/07/19 at 11:51am

Bayer’s oral TRK inhibitor Vitrakvi (larotrectinib) could be set to become the European Union’s first drug approved in a tumour-agnostic indication after it emerged that it had secured a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

The committee backed the approval of the therapy for the treatment of both adult and paediatric patients with solid tumours that a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion, or whose disease is locally advanced, metastatic or where surgical resection is anticipated to cause severe morbidity.

The decision was reached based on data drawn from 102 patients across three early-stage trials, in which the therapy showed a “high response rate with durable and rapid responses”, with an overall response rate (ORR) of 72%, a partial response rate (PRR) of 55%, and a complete response rate (CRR) of 16%. Three-quarters of patients experienced a duration of response lasting at least 12 months.  

Additionally, an analysis including primary CNS patients produced an ORR of 67%, while PRR and CRR stood at 51% and 15% respectively.

“This positive CHMP recommendation for the first-ever tumor agnostic indication in Europe marks an important step towards delivering a first-of-its -kind precision medicine for children and adults with TRK fusion cancer in Europe,” explained Dr Scott Z Fields, Senior Vice President and Head of Oncology Development at Bayer. “Larotrectinib was specifically developed to treat patients with TRK fusion cancer, and has the potential to significantly improve treatment outcomes, regardless of tumour type or age. As researchers learn more about tumour genomics, it becomes all the more important to ensure broad access to genomic testing to allow patients that have the potential to benefit from precision medicines to be identified and treated, moving us beyond a one-size fits all therapeutic approach.”

Vitrakvi has already secured approval in the US, Canada and Brazil, with a final European decision expected in the coming months.

Matt Fellows

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