NEW YORK, April 28 /PRNewswire-FirstCall/ -- 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 Inc
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