FDA approves Bayer’s kidney cancer drug
pharmafile | December 22, 2005 | News story | Sales and Marketing |
Bayer's Nexavar has become the first treatment in more than ten years to receive approval in the US for the most common type of kidney cancer, advanced renal cell carcinoma.
Co-developed by Bayer and US biotech Onyx, Nexavar (sorafenib) is an oral multi-kinase inhibitor, the first of a new generation of cancer treatments that inhibit the flow of blood to the tumours, killing off cells in the difficult to treat renal cancers.
"Nexavar is an oral anticancer drug that blocks tumour growth in new ways," said Arthur Higgins, chairman of Bayer HealthCares Executive Committee.
"It has demonstrated the ability to prolong progression-free survival. Nexavar has also been shown to delay the progression of cancer in the majority of patients with a manageable side-effect profile – an area that has been a challenge for patients and their physicians."
Current kidney cancer treatments are minimally effective and hard to tolerate and there is no chemotherapy drug used to treat other cancers that works well against it.
Over 30,000 new cases of kidney cancer are diagnosed each year in the US and analysts have predicted the drug will reach peak sales of E500 million.
But Bayer chief executive Werner Wenning said this could increase to E1 billion if Nexavar is licensed for lung cancer, for which it will enter phase III trials next year.
Bayer said it expects the treatment to be available for kidney cancer patients in Europe by the second half of 2006, following its September filing with the EMEA.
But Nexavar's global fortunes could be undermined by Pfizer's Sutent, a similar drug which has been filed with the FDA for the same indication and has shown to be more effective in shrinking tumours.
The two treatments will compete head-to-head, with Bayer and Onyx likely to argue that Nexavar boasts a superior safety profile, with side-effects limited mainly to blistering and rashes.
In comparison, trial results have shown that Pfizer's Sutent registered a higher rate of side-effects including hypertension, fatigue and diarrhoea.
Nexavar's US approval was based on data from the largest placebo-controlled trial ever conducted in patients with advanced renal cell cancer. Results showed that Nexavar doubled the time a patient lives without evident tumour growth compared to placebo.
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