FDA Approves A Cellular Immunotherapy For Men With Advanced Prostate Cancer

The U.S. Food and Drug Administration approved Provenge (sipuleucel-T), a new therapy for certain men with advanced prostate cancer that uses their own immune system to fight the disease.

Provenge is indicated for the treatment of asymptomatic or minimally symptomatic prostate cancer that has spread to other parts of the body and is resistant to standard hormone treatment.

Prostate cancer is the second most common type of cancer among men in the United States, behind skin cancer, and usually occurs in older men. In 2009, an estimated 192,000 new cases of prostate cancer were diagnosed and about 27,000 men died from the disease, according to the National Cancer Institute.

“The availability of Provenge provides a new treatment option for men with advanced prostate cancer, who currently have limited effective therapies available,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research.

Provenge is an autologous cellular immunotherapy, designed to stimulate a patient’s own immune system to respond against the cancer. Each dose of Provenge is manufactured by obtaining a patient’s immune cells from the blood, using a machine in a process known as leukapheresis. To enhance their response against the cancer, the immune cells are then exposed to a protein that is found in most prostate cancers, linked to an immune stimulating substance. After this process, the patient’s own cells are returned to the patient to treat the prostate cancer. Provenge is administered intravenously in a three-dose schedule given at about two-week intervals. Read more

Cancer Risk The Same For Kidney Transplant Recipients, No Matter The Drug

Drugs taken by kidney transplant recipients to prevent organ rejection carry similar risks of cancer, according to a study appearing in an upcoming issue of the Journal of the American Society Nephrology (JASN). The results suggest that no single medication is to blame for the higher incidence of cancer seen among patients who have undergone transplantation.

Individuals who receive a kidney transplant have an increased risk of developing cancer compared with the general population. Researchers suspected that the increased risk may come from immunosuppressive medications that patients must take long-term to prevent organ rejection. To investigate, Martin Gallagher, MBBS, FRACP (The George Institute for International Health in Australia) and his colleagues studied the incidence of cancer in transplant patients who took part in a randomized clinical trial 20 years ago, looking for any differences in cancer risk associated with different immunosuppressive drugs.

The researchers studied the incidence of cancer among 481 kidney transplant recipients in the Australian Multicentre Trial of Cyclosporine Withdrawal who each received one of three treatment regimens: azathioprine and prednisolone, cyclosporine monotherapy, or cyclosporine monotherapy followed by a switch to azathioprine and prednisolone after three months.

A total of 226 patients in the trial developed at least one cancer. By 20 years post transplant, 27% of patients developed non-skin cancer and 48% of patients developed skin cancer. One type of treatment did not have a greater effect on cancer timing or incidence than another, indicating that the therapies carry similar risks for cancer after kidney transplantation. Read more

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