The EC cleared Pfizer’s oral kinase inhibitor Inlyta® (axitinib) for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior therapy with sunitinib or a cytokine. The drug was approved by FDA in January for treating advanced RCC after failure of one prior systemic therapy, and is also sanctioned in other countries including Switzerland, Japan, Canada, Australia, and Korea.
Approval of Inlyta in the EU was based on data from the Phase III Axis study, which showed that, compared with sorafenib therapy, Inlyta extended average progression free survival by 45%, from 4.7 months to 6.8 months. “Pfizer Oncology recognizes advanced RCC is a complex disease and we are committed to bringing new targeted medicines to physicians and their patients,” comments Adreas Penk, M.D., regional president of Europe for Pfizer’s oncology business unit. “Inlyta is a valuable addition to Pfizer’s portfolio for the treatment of advanced RCC, which includes Sutent® (sunitinib malate), and Torisel® (temsirolimus).”