Bayer’s Vitravki becomes first EU-approved tumour-agnostic therapy
pharmafile | September 24, 2019 | News story | Manufacturing and Production, Research and Development, Sales and Marketing | Bayer, Cancer, Vitravki, pharma
Bayer has announced that its tyrosine receptor kinase (TRK) inhibitor Vitrakvi (larotrectinib) has scored approval from the European Commission for the treatment of locally advanced or metastatic solid tumours with an NTRK gene fusion in adult and paediatric patients who have no satisfactory treatment options, or for whom surgical resection is likely to result in severe morbidity.
The decision signifies the first approval of a therapy in Europe in a tumour-agnostic indication. It was based on data illustrating that the drug achieved an overall response rate of 72% in the primary analysis population of 93 patients, including 55% partial responses and 16% complete responses.
Additionally, 75% of responding patients saw a response that lasted at least 12 months, with responses ranging from 1.6 months to 38.7 months. After one year of treatment, 88% of participants were still alive.
Vitrakvi has already secured approval in the US, Canada and Brazil.
“With this first-ever tumour-agnostic approval in the EU, physicians in Europe now have the option to replace less tailored treatment approaches with a precision oncology treatment exclusively designed to treat tumours that have an NTRK gene fusion – a rare cancer which affects both children and adults and occurs in varying frequencies across various tumour types,” said Professor Jesus Garcia-Foncillas, Director of the University Cancer Institute and the Department of Oncology at the University Hospital “Fundacion Jimenez Diaz” and Professor of Oncology at the Autonomous University of Madrid, Director of the Translational Oncology Division at the Health Research Institute FJD-UAM and Coordinator of the Comprehensive Cancer Program of four University Hospitals in Madrid. “Existing therapies commonly used to treat TRK fusion cancer patients such as chemotherapy or immuno-oncology therapies have shown limited efficacy, and may have significant side effects. With Vitrakvi, we have seen rapid, robust and durable responses with a consistent and manageable safety profile in patients with TRK fusion cancer, regardless of the age of the patient or where in the body the tumour is located.”
Robert LaCaze, Member of the Executive Committee of Bayer’s Pharmaceuticals Division and Head of the Oncology Strategic Business Unit, also commented: “The approval of Vitrakvi in the EU, a first-of-its-kind treatment exclusively designed for adults and children with TRK fusion cancer, represents a meaningful advancement in the fight against cancer, as it treats the oncogenic driver that causes tumour spread and growth, rather than where the tumour originates in the body. Cancer care is currently undergoing a paradigm shift and as this new era of precision oncology treatment unfolds, we are continuing our effort of delivering innovative medicines such as Vitrakvi, which can provide value to patients and their treating physicians around the world.”
Matt Fellows
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