The U.S. Food and Drug Administration (FDA) have approved Kadcyla (ado-trastuzumab emtansine) from Roche, a drug for the treatment of a type of late-stage breast cancer.
This drug actually works against HER-2, which is the protein involved in normal cell growth and the amount of which is increased in some types of cancer cells including some breast cancers (which are HER2 positive). About 20% of patients of breast cancer have aggressive HER-2 production. According to the U.S. National Cancer Institute, about 232,340 women will be diagnosed with breast cancer, and 39,620 will die from the disease in U.S. in 2013.
“Kadcyla is trastuzumab connected to a drug called DM1 that interferes with cancer cell growth,” Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “Kadcyla delivers the drug to the cancer site to shrink the tumor, slow disease progression and prolong survival. It is the fourth approved drug that targets the HER2 protein.”
“This antibody goes seeking out the tumor cells, gets internalized and then explodes them from within. So it’s very kind and gentle on the patients – there’s no hair loss, no nausea, no vomiting,” Dr. Melody Cobleigh of Rush University Medical Center, said in a statement. “It’s a revolutionary way of treating cancer.”
Researchers worked on 991 patients and divided them into two groups. One group received Kadcyla and the other group received lapatinib plus capecitabine, another chemotherapy treatment. Researchers found that the progression-free survival of the group, who received Kadcyla, was 9.6 months as compared to 6.4 months in patients treated with lapatinib plus capecitabine. The median overall survival was 30.9 months in the Kadcyla group and 25.1 months in the lapatinib plus capecitabine group.
According to Roche’s Genentech, Kadcyla will cost about $9,800 per month as compared to $4,500 per month for regular Herceptin, which has long conquered the breast cancer marketplace. Kadcyla will cost $94,000 for nine months of medicine.
“We currently have more than 25 antibody-drug conjugates in our pipeline and hope this promising approach will help us deliver more medicines to fight other cancers in the future.” Hal Barron, M.D., chief medical officer and head, Global Product Development, said in a statement.
Among the other FDA-approved drugs for the treatment of HER2-positive breast cancer are trastuzumab (1998), lapatinib (2007) and pertuzumab (2012).