European Commission Grants Conditional Marketing Authorization to Pfizer's Sutent(R)

NEW YORK, July 27 /PRNewswire/ --

Pfizer Inc said today that Sutent(R) (sunitinib malate) has received European conditional marketing authorization for advanced and/or metastatic renal cell carcinoma (mRCC), a type of advanced kidney cancer, after failure of interferon alfa and interleukin-2 therapies.

Sutent was given conditional approval for unresectable and/or metastatic malignant gastrointestinal stromal tumor (GIST) after failure of the imatinib mesylate treatment due to resistance or intolerance. The efficacy is based on time to tumor progression and an increase in survival in GIST and an objective response rate for mRCC. The mRCC approval is conditional until the Committee for Human Medical Products (CHMP) reviews Sutent Phase 3 study data. Pfizer is submitting the data in August.

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.

"For many years, the options available for people with metastatic kidney cancer have been very limited," said Dr. Sylvie Negrier, M.D., Ph.D., professor of Medical Oncology at Centre Leon Berard, Lyon, France. "To have approximately 35 percent of patients in the pivotal study respond to this treatment is truly remarkable. Also, a large majority of patients were able to control their disease over time. These are signs of Sutent's significant effects in patients fighting kidney cancer."

Sutent has been granted Orphan Drug designation in the European Union for both advanced kidney cancer and GIST, two rare types of cancer that affect less than 0.5% of the European population.

"Patients who had few choices now have a new treatment option for GIST and mRCC," said Dr. Joseph Feczko, Pfizer's chief medical officer. "Interim data showed that Sutent prolonged time to tumor progression in clinical study participants with resistant GIST and showed remarkable response rates and response duration across multiple studies in patients with metastatic kidney cancer."

Clinical Studies

The European Commission's conditional authorization of Sutent to treat cytokine-refractory mRCC is based on data from two Phase 2 open-label studies involving 169 advanced kidney cancer patients for whom standard therapies had failed. Sutent-treated patients experienced an objective response rate of 38 percent in the confirmatory study and 36.5 percent in the supportive study. An objective response rate is the combined percentage of patients whose tumors responded partially or completely to treatment. In responding patients, median duration of response has not been reached in the confirmatory study.

The European Commission's GIST approval of Sutent is based on data from a Phase 3 study involving 312 patients with imatinib-resistant or intolerant metastatic GIST. The median time to tumor progression was significantly prolonged to 28.9 weeks for Sutent-treated patients versus 5.1 weeks for patients who received placebo.

Sutent's side effects were generally moderate. In clinical trials, the most common treatment-related side effects (experienced by at least 20% of patients) included fatigue; gastrointestinal disorders such as diarrhea, nausea, stomatitis, dyspepsia, and vomiting; skin discoloration; loss of taste and anorexia.

The most serious side effects associated with Sutent treatment of solid tumor patients were pulmonary embolism (1.1 percent), thrombocytopenia (1.1 percent), tumor hemorrhage (0.9 percent), febrile neutropenia (0.4 percent), and hypertension (0.4 percent). Patients should be screened for hypertension and appropriately controlled with medical management. Temporary suspension of Sutent is recommended in patients with severe hypertension that is not controlled with medical management.

Pfizer Oncology

"The need for new cancer treatments remains great," said Dr. Charles Baum, vice president of Pfizer Global Research and Development and oncology clinical leader. "Cancer killed an estimated 14 people every minute of 2005, making it a leading cause of death globally. Hundreds of Pfizer scientists and physicians are working in our laboratories, and closely with the health care community, to transform cancer into a disease patients live with instead of one they die from."

Pfizer's Global Research and Development group has more than 200 cancer studies underway, examining potential new treatments across a broad range of tumor types. Pfizer's scientists are working to fight cancer through a deeper understanding of the disease at the molecular level, designing and developing new medicines to influence these molecular defects. Pfizer Oncology has two compounds in Phase 3 clinical trials, CP-675,206 and PF-351,2676; five compounds in Phase 2 trials and seven compounds in Phase 1 trials, as well as a robust preclinical pipeline of growth factor receptor, checkpoint and angiogenesis inhibitors and immunotherapies.

Sutent was approved in the U.S. by the U.S. Food and Drug Administration (FDA) in January 2006 for the treatment of gastrointestinal stromal tumor after disease progression or intolerance to imatinib mesylate and advanced renal cell carcinoma. Approval for advanced renal cell carcinoma is based on partial response rates and duration responses. There are no randomized trials of Sutent demonstrating clinical benefit such as increased survival or improvement in disease-related symptoms in renal cell carcinoma. This was the first time the FDA approved a new cancer medicine for two indications simultaneously.

The European Commission grants conditional marketing authorization for medicines to treat diseases with few available treatment options when a full clinical data package is not yet available in order to meet unmet medical needs of patients and in the interests of public health. (Commission Regulation No 507/2006).

For more information on Sutent and Pfizer's cancer support programs, please visit www.pfizeroncology.com.

Web site: http://www.pfizeroncology.com

SOURCE Pfizer Inc