U.S. Food And Drug Administration Approves Pfizer’s INLYTA® (axitinib) For Patients With Previously Treated Advanced Renal Cell Carcinoma (RCC)

08 Feb 2012 12:54 PM | Lori Aubrey (Administrator)
The U.S. Food and Drug Administration (FDA) has approved INLYTA® (axitinib), a kinase inhibitor, for the treatment of patients with advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy. The approval is based on data from the Phase 3 AXIS trial, which demonstrated that INLYTA significantly extended progression free survival (PFS) [HR=0.67, 0.54-0.81, P<0.0001] with a median PFS of 6.7 months (95% CI: 6.3, 8.6) compared with 4.7 months (95% CI: 4.6, 5.6) for those treated with sorafenib, a current standard of care for this patient population, representing a 43 percent improvement in median PFS compared to sorafenib. For more information and full prescribing information please visit www.InlytaHCP.com.

View this and other FDA Approvals on the dedicated FDA Approvals page under theResources section of our website.


Northern New England Clinical Oncology Society
P.O. Box 643
Sandown, NH 03873-0643
Telephone (603) 887-1948

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