Pfizer says drug will be available for use Feb. 3

January, 2006 – The United States Food and Drug Administration (FDA) announced Jan. 26 that it has approved Sutent (sunitinib) for patients with gastrointestinal stromal tumors (GIST) and advanced kidney cancer.

It was the first time the agency has approved a new oncology product for two cancers simultaneously.

Sutent, which received a priority review and was approved in less than six months, is a tyrosine kinase inhibitor. The once-daily, 50 mg. capsule blocks several enzymes that deprive the tumor cells of the blood and nutrients needed to grow.

“Today’s approval is a major step forward in making breakthrough treatments available for patients with rare and difficult to treat forms of cancer,” said Dr. Steven Galson, director of FDA’s Center for Drug Evaluation and Research. “New targeted therapies such as Sutent are helping FDA expand options for patients for whom there are limited alternatives.”

According to the American Cancer Society, about 6,000 new cases of GIST and 32,000 cases of advanced kidney cancer are diagnosed each year.

Sutent won approval for the treatment of Gleevec-resistant GIST and for GIST patients unable to tolerate Gleevec, the current treatment for GIST. In clinical trials, researchers did an early analysis of data that showed Sutent delayed the time it took for tumors or new lesions to grow. Specifically, the median time-to-tumor progression for patients treated with Sutent was 27 weeks compared to six weeks for patients given a placebo.

Of 312 clinical trial participants, 207 received Sutent, while 105 were given placebos.

Typically, patients in cancer trials are not given placebos because it is considered unethical to deny them effective treatments. But Sutent maker Pfizer said a third of the patients were given placebos in this trial because no standard drug is known to work against such stomach tumors once they develop resistance to Gleevec.

When it became clear that patients taking Sutent were surviving longer than the placebo group, all patients in the study were allowed to start taking Sutent.

FDA also granted accelerated approval for Sutent in the treatment of patients with advanced renal cell carcinoma (RCC). In contrast to the approval for GIST, which was based on the drug’s ability to delay the growth of the tumors, this approval was based on Sutent’s ability to reduce the size of the tumors in patients. An overall response rate ranging from 26 to 37 percent was found in patients with metastatic kidney cancer whose tumors had progressed following cytokine-based therapy.

Pfizer is studying the drug for use in treating other cancers, including colorectal, breast and lung cancer.

Pfizer says it expects the average cost of Sutent per six-week treatment cycle to be about $4,000, putting the annual cost of treatment at about $38,000. The drug is expected to be available to patients Feb. 3, and will come in 12.5 mg., 25 mg. and 50 mg. capsules.

Patients and physicians can visit www.sutent.com or phone FirstRESOURCE at (877) 744-5675 for information about patient assistance for those who don’t have drug coverage and for information about reimbursement issues or appeals assistance.

The FDA said in a statement that it has a long-standing commitment of providing patients with serious and life-threatening diseases access to safe and effective treatments, in some cases prior to FDA approval.

In the GIST clinical trial, significant clinical benefit was determined through an interim analysis of data, thereby allowing researchers to convert all patients in the trial to treatment.

FDA worked with Pfizer, maker of Sutent, to offer an expanded access program prior to approval, making the product available to patients not enrolled in a clinical trial. Currently, more than 1,700 U.S. patients are being treated with Sutent through the expanded access program.

“Expanded access programs have proven to be an effective way to get treatment to patients who need it most, especially in cancer,” said Ellen Stovall, president of the National Coalition of Cancer Survivorship. “There needs to be a greater awareness among patients and doctors about both the option to participate in clinical research as well as in these expanded access programs in order to make promising new therapies available to as many patients as possible.”

Pfizer said the most commonly reported side effects included diarrhea, nausea, stomatitis, dyspepsia, and vomiting. Patients also experienced, fatigue, high blood pressure, bleeding, swelling, and altered taste. Hypothyroidism was also observed.

Skin discoloration possibly due to the drug color (yellow) occurred in approximately a third of patients. Other possible dermatologic effects may include dryness, thickness or cracking of skin, blister or rash on the palms of the hands and soles of the feet.

Pfizer, which acquired Sutent in 2003 through its purchase of Pharmacia Corp., has said it intends to become a major player in the oncology arena. It is now far better known for drugs such as Viagra and cholesterol fighter Lipitor.