Healthcare Industry News:  sunitinib malate 

Biopharmaceuticals Oncology Regulatory

 News Release - April 28, 2006

Pfizer's Sutent Receives Positive Opinion in the European Union For Two Difficult-To-Treat Advanced Cancers

NEW YORK, April 28 (HSMN NewsFeed) -- Pfizer Inc said today that the Committee for Human Medicinal Products (CHMP) issued a positive opinion recommending conditional marketing authorization for Pfizer's new cancer medicine Sutent (sunitinib malate) to treat metastatic renal cell carcinoma (mRCC), or advanced kidney cancer, after failure of interferon alpha or interleukin-2-based therapy. The positive opinion was also granted for gastrointestinal stromal tumor (GIST), a rare stomach and intestinal cancer, in patients who are resistant or intolerant to imatinib mesylate.

The recommended approval is for conditional marketing authorization, which means additional data will be submitted to confirm the risk-benefit of Sutent for mRCC patients. This is the first time the CHMP has used the new directive intended for drugs for patients with an unmet medical need.

Developed by Pfizer, Sutent is an oral therapy belonging to a new class of multi-kinase inhibitors that attack cancer by inhibiting both tumor growth and blood supply.

"Sutent is an important advance in cancer treatment for patients with currently limited treatment options," said Dr. Joseph Feczko, Pfizer's chief medical officer. "Because the need for new treatments is so great, cancer is an extremely important research priority for Pfizer. Sutent represents our commitment to give patients more choices and improved quality of life."

The primary treatment option for newly diagnosed GIST and mRCC patients is surgery. GIST patients with advanced disease after surgery are treated with imatinib mesylate, where patients with mRCC are generally treated with cytokines. For patients with advanced cancers following these treatments, there are currently few treatment options. mRCC is a type of kidney cancer that affects more than 37,000 people each year in Europe. GIST, a rare type of soft-tissue cancer found in the gastrointestinal tract, is diagnosed in more than 6,000 Europeans annually.

The U.S. Food and Drug Administration (FDA) approved Sutent in January 2006 for the treatment of advanced RCC as well as GIST in patients whose disease has progressed or who are unable to tolerate treatment with imatinib mesylate. Sutent's U.S. approval was the first time that the FDA approved a new cancer medicine for two indications simultaneously.


Source: Pfizer

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