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Home Industry News Pfizer applies for EU approval of axitinib

Pfizer applies for EU approval of axitinib

2nd June 2011

Pfizer has submitted an application to the European Medicines Agency (EMA) in the hopes of securing its first regulatory approval for its new cancer drug axitinib.

The company is seeking a regulatory review of the compound as a potential therapy for advanced renal cell carcinoma (RCC) patients who have failed to respond to prior systemic treatment.

This application is based on positive data from a phase III trial, Axis 1032, full results from which are to be presented at the American Society of Clinical Oncology annual meeting this month.

Garry Nicholson, president and general manager of Pfizer's oncology business unit, said: "This regulatory filing for our innovative investigational therapy axitinib … underscores Pfizer's commitment to patients with advanced RCC and our leadership in helping physicians treat this disease."

The drug is also being trialled among treatment-naive RCC patients and as a therapy for hepatocellular carcinoma.

Last month, Pfizer and its partner Bristol-Myers Squibb secured European regulatory approval for Eliquis, a treatment for venous thromboembolic events among orthopaedic surgery patients.ADNFCR-8000103-ID-800564771-ADNFCR

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