Pfizer has been granted a positive opinion from the European Medicines Agency's (EMA) Committee for Human Medicinal Products (CHMP) for its oral protein kinase inhibitor axitinib as a second-line treatment for adults with advanced renal cell carcinoma (RCC).
The positive opinion is for use of Inlyta (axitinib) after failure of earlier treatment with Pfizer's Sutent (sunitinib) or cytokine-based therapy.
In January, the US FDA approved axitinib under the Inlyta brand name as a second-line treatment for advanced RCC, becoming the third Pfizer drug to be registered for the indication after Sutent and Torisel (temsirolimus).
"The benefits with Inlyta are its ability to delay the progression of disease in patients previously treated with sunitinib and its ability to improve the survival and to delay the progression of disease in patients previously treated with cytokines," said the CHMP.
The most common side effects associated with axitinib are diarrhoea, hypertension, fatigue, dysphonia, nausea, decreased appetite, and hand-foot syndrome, it added.
RCC is becoming an increasingly well-served indication, with Bayer/Onyx's Nexavar (sorafenib), GlaxoSmithKline's Votrient (pazopanib), Novartis' Afinitor (everolimus) and Roche/Genentech's Avastin (bevacizumab) all approved to treat various stages of the disease.
Despite the number of treatment options already available, Inlyta is expected to do reasonably well in the marketplace, thanks to data from the phase III AXIS trial. This showed that Inlyta extended progression-free survival (PFS) by 6.7 months compared with Nexavar which extended PFS by 4.7 months.
Analysts have predicted that it will achieve peak sales in excess of $500m a year, perhaps higher if clinical trials expand its use into other indications, such as liver cancer, and first-line therapy in RCC.
Dr Mace Rothenberg, senior vice president of clinical development and medical affairs for Pfizer's oncology division, said: "[D]espite recent advances in the treatment of advanced kidney cancer, there is a clear need for additional treatment options for patients whose disease has progressed following first-line medications."