FDAnews
www.fdanews.com/articles/75681-study-finds-temsirolimus-promising-for-treatment-of-breast-cancer

STUDY FINDS TEMSIROLIMUS PROMISING FOR TREATMENT OF BREAST CANCER

August 23, 2005

According to three studies published in the Journal of Clinical Oncology, treatment with the investigational drug temsirolimus, a cell signal blocker, may be effective against several types of cancer.

Temsirolimus is an agent that controls the growth of cells by blocking cell signals and preventing cell division. Temsirolimus has been given fast-track status by the FDA for the treatment of advanced kidney cancer. Fast-track designation does not guarantee eventual FDA approval, but it helps speed the development of drugs intended to treat life-threatening conditions for which there are few other treatment options.

The study of temsirolimus for treatment of lymphoma involved 35 patients with relapsed or refractory mantle cell lymphoma. Mantle cell lymphoma is an aggressive type of B-cell non-Hodgkin's lymphoma. Patients were treated with 250 mg of temsirolimus per week. Twelve patients experienced a reduction in detectable lymphoma after treatment. One patient experienced a complete disappearance of detectable lymphoma. The most common adverse effect of treatment was low blood platelet levels. The researchers conclude that treatment with temsirolimus results in a substantial anti-lymphoma response in this poor-prognosis patient population.