The US Food and Drug Administration has approved Bayer and Onyx Pharmaceuticals’ Nexavar (sorafenib tosylate), the first new drug in more than a decade to treat adults with advanced renal cell carcinoma.
Nexavar, one of the brightest prospects in Bayer’s near-term pipeline, will be shipped to hospitals and pharmacies in the USA almost immediately.
The drug has been approved as a first-line treatment for renal cell carcinoma on the back of placebo-controlled clinical studies showing that Nexavar doubled progression-free survival from three to six months on average. Interim results from ongoing studies have also suggested that it can improve overall survival by nearly 40%.
Meanwhile, Nexavar appears to be much less toxic than current treatments for this type of cancer, such as interleukin-2 or interferon-alpha, and has the additional benefit of being dosed orally rather than by injection. All this adds up to a drug with real blockbuster potential, according to Bayer, which is predicting sales of 1 billion euros ($1.2bn) for the product.
Nexavar is seen as crucial to the continued recovery of Bayer’s pharmaceutical business, which has struggled to overcome the problems caused by the 2001 withdrawal of its cholesterol-lowering drug Lipobay/Baycol (cerivastatin) and subsequent drug liability lawsuits.
Bayer and Onyx have submitted applications to the European Medicines Agency and five other countries to approve Nexavar as a kidney-cancer treatment, and also plan to start Phase III studies in non-small cell lung cancer the first half of next year.
Kidney cancer accounts for approximately 3% of all adult cancers in the USA, the FDA said. About 32,000 new cases are diagnosed and about 12,000 people die from the disease annually. Renal cell carcinoma is the most common form.