German drugmaker Bayer Healthcare AG and the USA's Onyx Pharmaceuticals say they have received a positive opinion from the Committee for Medicinal Products for Human Use regarding their co-developed anticancer agent Nexavar (sorafenib). The drug is being assessed as a treatment for patients with advanced renal cell carcinoma or kidney cancer, who have experienced failed interferon-alpha or interleukin-2 based therapy.
The product, which is designed as a film-coated 200mg dose, has demonstrated the ability to double the rate of progression-free survival in patients with advanced RCC (Marketletter February 27).
The company added that the compound, which received approval for use in the treatment of RCC from the US Food and Drug Administration in December of last year, has also been granted clearance by the Mexican Ministry of Health for use by RCC and kidney cancer patients.
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