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Tuesday, March 13, 2007

Breast cancer drug wins FDA approval

By Scott Allen, Globe Staff

Federal regulators today approved a new treatment for breast cancer that oncologists believe could be the second coming of Herceptin, one of the most successful anti-cancer drugs of the last decade.

The Food and Drug Administratrion is expected to approve Tykerb, also called lapatinib, for women with advanced cancer that can no longer be controlled by Herceptin, but major studies are already underway to find out if Tykerb should also be given to millions of women who are in the early stages of cancer.

Dr. Paul Goss, director of breast cancer research at Massachusetts General Hospital, is leading a trial of Tykerb in 3,000 breast cancer patients who have recently undergone chemotherapy. Goss's TEACH trial (Tykerb Evaluation After Chemotherapy) will help the FDA -- and drugmaker GlaxoSmith Kline Plc -- determine just how effective the drug is in women whose cancer has not spread to other parts of their bodies.

Goss said Tykerb might be even more effective than Herceptin, which is credited with extending the life expectancy by more than 1.5 years for women who suffer HER-2 positive breast cancer. Tykerb, he said, appears to shut down more molecular pathways that lead to cancer than Herceptin partly because Tykerb molecules are small enough to get inside cancer cells. As a result, he said Tykerb could be stronger than Herceptin and work in some women other than the 20 to 30 percent who have the HER2-positive form of the disease.

"If I can equate it to lighting a building and your task is to turn all the lights off, you can go room by room and turn them off, or if you're lucky, you discover a circuit breaker that can shut down whole floors," said Goss. Tykerb "might be that circuit breaker."

Goss said it's premature for doctors to prescribe Tykerb for early stage breast cancer unless women can't take Herceptin for some reason, such as side effects. In the long run, he said doctors will likely need both, though women may like Tykerb better because, unlike Herceptin, it's a pill rather than an injection.

Posted by Karen Weintraub at 04:08 PM
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