Pfizer's axitinib favored by FDA panel

Global drugs behemoth Pfizer (NYSE: PFE) says that the U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) voted unanimously 13 to 0 that data for the investigational oral agent axitinib (proposed trade name Inlyta) support a favorable benefit/risk profile for the treatment of patients with advanced renal cell carcinoma (RCC) after failure of a first-line systemic therapy.

The drug, which was filed for approval in Europe earlier this year (The Pharma Letter June 2), was found to be at least as safe and effective as previously-approved treatments for the disease, such as German drugmaker Bayer and Onyx Pharma’s Nexavar (sorafenib). It also had different side effects than other drugs for the disease, which could be important for patients who cannot tolerate older treatments, said Wyndham Wilson, chairman of the panel and chief of the lymphoma therapeutics section at the National Cancer Institute.

Peak sales of $576 million forecast