EC GRANTS CONDITIONAL AUTHORIZATION TO PFIZER'S CANCER DRUG

Pfizer has announced that Sutent (sunitinib malate) has received European Commission (EC) conditional marketing authorization for advanced or metastatic renal cell carcinoma, a type of advanced kidney cancer. Sutent is an oral therapy belonging to a new class of multi-targeted drugs that attack cancer by inhibiting both tumor growth and blood supply.

The drug was previously given conditional approval for unresectable or metastatic malignant gastrointestinal stromal tumor after failure of other treatment due to resistance or intolerance. The kidney cancer approval is conditional until the Committee for Human Medical Products reviews Sutent Phase III study data, which Pfizer is submitting in August.

Sutent has been granted orphan drug designation in the European Union for both types of cancer.