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Nexavar gets EU go-ahead in advanced kidney cancer

Published on 27/07/06 at 12:38pm

Bayer has received the green light from European regulators for Nexavar to treat the most common type of kidney cancer - advanced renal cell carcinoma.

Last December, Nexavar became the first drug for 10 years to receive US approval for the disease in patients who have failed prior interferon-alpha or interleukin-2 based therapy or are unsuitable for such treatment.

Nexavar (sorafenib) is an oral multi-kinase inhibitor and the first of a new generation of cancer treatments that inhibit the flow of blood to kidney tumours  killing off cells in difficult-to-treat renal cancers.

Current kidney cancer treatments are minimally effective with low toleration levels and, currently, there is no chemotherapy drug available which works well against the disease.

Dr Gunnar Riemann, head of Bayer HealthCare Pharmaceuticals Division, said: "This (EC) approval of Nexavar  which has shown to double progression-free survival  is a significant advance in the fight against kidney cancer."

He added: "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 need."

More than 200,000 people worldwide are diagnosed with kidney cancer each year and more than half of these will die from the disease.

In Europe, it is estimated there are more than 46,000 new cases each year  and in one third of cases, the cancer has already spread to other parts of the body at the time of diagnosis.

Bayer co-developed Nexavar with California-based Onyx Pharmaceuticals and the companies will co-promote the treatment in the US, while Bayer has exclusive marketing rights in all other countries except Japan.

US analysts predict peak-year sales of 500 million euros for Nexavar - but Bayer believes this sum could increase to one billion euros if the drug can gain a licence to treat lung cancer. Phase III trials for this indication are currently under way.

Nexavar is competing against Pfizer's Sudent (sunitinib), a similar drug that was approved by the FDA in January for advanced kidney cancer and gastrointestinal stromal tumours.

European approval for Sutent is expected soon, after experts at the CHMP recommended it be licensed in April this year.

Bayer is likely to argue that Nexavar boasts a superior safety profile to Pfizer's drug, with side effects limited mainly to blistering and rashes. In comparison, trial results show that Sudent registered a higher rate of side-effects, including hypertension, fatigue and diarrhoea.

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