FDA accepts Pfizer RCC drug application for review

The application for the drug was based on AXIS 1032 Phase 3 trial results which showed that Axitinib extended progression-free survival (PFS) when compared to sorafenib, in the study population.

Pfizer Oncology Business Unit president and general manager Garry Nicholson said this filing represents a step towards accomplishing Pfizer’s goal of bringing axitinib to advanced RCC patients who are in need of additional, effective treatment options.

"We are excited about the benefits which axitinib has demonstrated in clinical development and, subject to FDA review, its potential to improve the lives of patients," Nicholson said.