Bayer gets EU approval for Nexavar kidney cancer drug

Bayer has said its new treatment for advanced renal cell carcinoma (advanced kidney cancer) has been approved by the European Commission for marketing.

Nexavar tablets are to be prescribed to advanced kidney cancer patients who have failed to respond adequately to interferon-alpha or interleukin-2 based therapy.

The approval follows a positive recommendation from the European Medicine Agency’s committee on medicinal products for human use, as well as approval by the FDA in the US and regulatory filings in Australia, Canada, Turkey and Japan. Nexavar could become available in the UK after a NICE appraisal.

Dr Gunnar Riemann, head of Bayer HealthCare’s pharmaceuticals division, remarked: “Today’s approval of Nexavar, which has shown to double progression-free survival, is a significant advance in the fight against kidney cancer.”

“For more than a decade, Europeans with kidney cancer have not had a new approved treatment. We are pleased to play a part in addressing this unmet medical need,” he added.

In phase III studies, the progression-free survival time of patients with advanced kidney cancer was extended to six months for Nexavar users, in comparison to three months for patients taking the placebo.

According to Cancer Research UK, more than 6,600 people in the UK are diagnosed with kidney cancer. Some 62 per cent of these patients are over 65-years-old, while the disease is described as rare among people under 50-years-old.

It says that smoking could more than double the risk of developing the disease. The disease is often characterised by the presence of blood in urine, although the charity points out that the majority of cases of blood presence in urine are not caused by kidney cancer.

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