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Bayer and Janssen extend clinical investigation of cancer drug Xarelto

Bayer HealthCare and Janssen Pharmaceuticals have started the Callisto Clinical Research Program to explore the potential benefits of the oral Factor Xa inhibitor Xarelto (rivaroxaban) to prevent and treat pulmonary embolism and deep vein thrombosis in patients with various types of cancer.

In patients with active cancer, the risk of venous thromboembolism (VTE) is four to seven times higher than in people of the same age without cancer, while chemotherapy increases the risk further by up to 6.5 times.

European Hospital Georges Pompidou Université Paris Descartes professor and one of the principal investigators within the Callisto Program Guy Meyer said: "Today, there is limited evidence and guidance on the routine use of anticoagulants for the long-term treatment and prevention of pulmonary embolism and deep vein thrombosis in patients with cancer, despite blood clots being the leading cause of death in patients with cancer outside the cancer itself.

"I am optimistic that results from the Callisto Program will provide important clinical insights to help reduce the risk of pulmonary embolism and deep vein thrombosis, conditions that can be treated and prevented."

Callisto is a multi-trial prospective clinical research initiative in the management of cancer-associated thrombosis (CAT). It will address three key areas of CAT: prevention of VTE, treatment and secondary prevention of VTE and important clinical aspects.

This program will include nine initiatives in total, comprising both clinical studies and Registries, and will involve over 4,000 patients worldwide.

Bayer HealthCare member of the Executive Committee and chief medical officer Dr Michael Devoy said: "The Callisto Program is an important milestone for Bayer in our ongoing work to address unmet medical needs through our experience in both oncology as well as thrombosis management.

"Callisto will build on the existing clinical evidence for rivaroxaban in the prevention and treatment of potentially deadly blood clots across a broad range of indications and patients."