FDA's ODAC unanimously backs axitinib

FDA's Oncologic Drugs Advisory Committee voted 13-0 that data support a favorable benefit-risk profile for Inlyta axitinib from Pfizer Inc. (NYSE:PFE) as a second-line therapy for advanced renal cell carcinoma (RCC). The panel brushed off FDA concerns that the two-month progression-free survival benefit shown by the compound over Nexavar sorafenib in a Phase III trial was driven by patients who received cytokines as front-line treatment. The agency called the subset "rare" in briefing documents posted Monday (see BioCentury Extra, Dec. 5).

In response to committee members' concerns about the magnitude of axitinib's benefit vs. Nexavar, Richard Pazdur, director of CDER's Office of Hematology and Oncology Products (OHOP), told panelists that "there is no comparative effectiveness requirement here, just the demonstration of safety and efficacy." He pointed out that Pfizer was the first sponsor to match its compound against an approved tyrosine kinase inhibitor in the RCC setting, adding, "you don't need to beat the active control necessarily [to receive approval], but they did." ...