Kadcyla, from Roche, is a combination of the drug Herceptin, a powerful chemotherapy drug, as well as a third chemical that links the two treatments together and keep everything intact until it can bind to the cancer cell.
Researchers say that Kadcyla may be superior to its predecessors because it delivers more potent treatment – with less side effects.
The FDA approved the new treatment for about 20 percent of breast cancer patients with a form of the disease that is typically more aggressive and less responsive to hormone therapy. These patients have tumors that overproduce a protein known as HER-2.
Kadcyla will cost $9,800 per month, compared to $4,500 per month for rHerceptin. The company estimates a full course of Kadcyla, about nine months of medicine, will cost $94,000.
FDA scientists said they approved the drug based on company studies showing Kadcyla delayed the progression of breast cancer by several months. Researchers reported last year that patients treated with the drug lived 9.6 months before death or the spread of their disease, compared with a little more than six months for patients treated with two other standard drugs, Tykerb and Xeloda.
FDA specifically approved the drug for patients with advanced breast cancer who have already been treated with Herceptin and taxane, a widely used chemotherapy drug.
Kadcyla will carry a boxed warning, the most severe type, alerting doctors and patients that the drug can cause liver toxicity, heart problems and potentially death. The drug can also cause severe birth defects and should not be used by pregnant women.