Log in or Register for enhanced features | Forgotten Password?
White Papers | Suppliers | Events | Report Store | Companies | Dining Club

Regulatory Affairs
Return to: PBR Home | Regulatory Affairs

Pfizer receives FDA approval for advanced RCC drug

PBR Staff Writer Published 30 January 2012

Pfizer has received FDA approval for INLYTA (axitinib), a kinase inhibitor, for the treatment of patients with advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy.

INLYTA is an oral therapy designed to selectively inhibit vascular endothelial growth factor receptors 1, 2 and 3, which can influence tumor growth, vascular angiogenesis and progression of cancer.

The Phase III AXIS trial data has demonstrated that INLYTA extended progression free survival with a median PFS of 6.7 months compared with 4.7 months for those treated with sorafenib.

Pfizer oncology business unit president and general manager Garry Nicholson said INLYTA is an important addition to the portfolio of treatment options for patients with advanced RCC.

Pfizer oncology business unit clinical development and medical affairs senior vice president Mace Rothenberg said INLYTA is the first targeted therapy to be approved in US for advanced RCC patients.

Comments
Post a comment

Comments may be moderated for spam, obscenities or defamation.