FDA approval sought for Pfizer's new cancer drug

Aug 11 2005

Drug company Pfizer has announced it has submitted a New Drug Application (NDA) for its cancer drug Sutent, to the U.S. Food and Drug Administration (FDA).

The company is seeking FDA approval for Sutent as a treatment for malignant gastrointestinal stromal tumor and metastatic renal cell carcinoma, in the main for patients whose tumors do not respond to or do not tolerate the standard treatment options.

As Sutent promises to provide a significant benefit over existing therapy for serious or life-threatening illnesses for which no therapy exists, the FDA has granted Sutent fast-track status.

Sutent, which is an oral, multi-targeted cancer therapy, combines anti-angiogenic and anti-tumor activity which simultaneously stops the blood supply to, and directly attacks, tumor cells.

Apparently over 2,000 patients have already received Sutent as part of Pfizer's clinical trial program.

Sutent which was developed by Pfizer, is also is being studied alone and in combination with other medications, as a treatment for a number of other solid tumors, including breast, lung, prostate, and colorectal cancers.

It is one of the first of a new class of drugs that selectively targets multiple protein receptors, called receptor tyrosine kinases (RTKs), and it is believed that inhibiting these RTKs starves tumors of the blood and nutrients needed for growth.

The drug also simultaneously kills the cancer cells that make up the tumors.

Pfizer says it is committed to advancing the scientific understanding of cancer, and to producing new drugs which address, the as yet, unmet medical needs of some cancer patients.

Oncology is one of Pfizer's research priorities, and a considerable portion of the company's research and development investment is devoted to discovering and developing innovative therapies for treating breast, colorectal and other cancers.