Pfizer files NDA for Sutent in US
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BY OUR PHARMA CORRESPONDENT
13th August,2005:Pfizer Inc has submitted a
New Drug Application for its cancer medicine
SU11248 (sunitinib malate), known as Sutent, to
the US Food and Drug Administration, the company
announced in a press release.
Pfizer is seeking FDA approval for Sutent as a
treatment for malignant gastrointestinal stromal
tumor and metastatic renal cell carcinoma among
patients whose tumors do not respond to or do not
tolerate standard treatment options.
The FDA has granted Sutent fast-track status since
Sutent may provide significant benefit over
existing therapy for serious or life-threatening
illnesses for which no therapy exists.
Sutent is an oral, multi-targeted cancer therapy
that combines anti-angiogenic and anti-tumor
activity to simultaneously stop the blood supply
to and directly attack tumor cells. Over 2,000
patients have received Sutent as part of Pfizer's
clinical trial program.
Developed by Pfizer, Sutent also is being studied
alone and in combination with other medicines as a
treatment for a number of other solid tumors,
including breast, lung, prostate, and colorectal
cancers.
Sutent is one of the first in a new class of drugs
that selectively targets multiple protein
receptors, called receptor tyrosine kinases (RTKs).
Inhibition of these RTKs is believed to starve
tumors of blood and nutrients needed for growth
and simultaneously kill the cancer cells that make
up tumors.
Pfizer Inc discovers, develops, manufactures, and
markets leading prescription medicines for humans
and animals. The company has three business
segments: health care, animal health and consumer
health care.
Pfizer products are available in more than 150
countries. Oncology is a research priority for
Pfizer, with a significant portion of the
company's research and development investment
devoted to discovering and developing innovative
therapies for treating breast, colorectal and
other cancers.
BY OUR PHARMA CORRESPONDENT |
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