NEW YORK (CNNMoney.com) -
An experimental drug combination from Wyeth helps women in the advanced stages of breast cancer live longer, the company said Thursday.
Temsirolimus, the experimental breast cancer drug, nearly doubles the survival time in breast cancer patients when it is combined with the Novartis drug Femara, Wyeth announced at the San Antonio Breast Cancer Symposium.
Women in the advanced stages of metastatic breast cancer for whom previous treatments had failed, including mastectomies, survived for an average of 18 months while taking the Temsirolimus-Femara combination, said Dr. Lee Allen, vice president of oncology clinical research and development at Wyeth. Patients who took only Femara, also known as letrozole, the standard treatment, survived for nine-and-a-half months, said Allen.
Allen emphasized that this is "progression free" survival, which means the cancer was not spreading during this time.
The results come from Wyeth's second phase Temsirolimus studies, said Allen. Wyeth has already begun the third phase, which is typically the last set of experiments before a drug is filed with the Food and Drug Administration.
Wyeth hopes to complete its clinical studies for Temsirolimus in late 2006 and file it with the FDA as a breast cancer drug in the fourth quarter of 2006, said Gerald Burr, vice president of scientific communications for Wyeth.
"If these results are shown in larger studies, they would clearly be beneficial to the product and helpful to the company," said Robert Hazlett, analyst for Suntrust Robinson Humphrey. "The product could reach several hundred million [dollars] in sales if larger studies bear this out."
Temsirolimus has also been tested as a treatment for renal cell carcinoma, which is a form of kidney cancer. Burr said clinical studies have been completed, but the data won't be released until the second quarter of 2006.
Temsirolimus is also being studied as a treatment for mantle cell lymphoma, a malignant but uncommon form of cancer in the lymphatic system. Wyeth (up $0.80 to $44.30, Research) hopes to complete studies late in 2006 and submit the drug to the FDA in the fourth quarter, 2006.
If Temsirolimus is approved for all these indications, annual drug sales are projected to peak at $500 million, said Burr.
Novartis (up $0.82 to $53.12, Research), the maker of Femara, was not immediately available for comment.
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