FDA Confirms Approval of Kadcyla for Breast Cancer

Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration (FDA) has approved Kadcyla™ ^ (ado-trastuzumab emtansine or T-DM1) for the treatment of people with HER2-positive metastatic breast cancer (mBC) who have received prior treatment with Herceptin^® (trastuzumab) and a taxane chemotherapy. Kadcyla is the fourth medicine from Genentech to receive FDA approval for people with advanced cancers within the past two years. An antibody-drug conjugate (ADC) is a new kind of targeted cancer medicine that can attach to certain types of cancer cells and deliver chemotherapy directly to them. Kadcyla is the first FDA-approved ADC for treating HER2-positive mBC, an aggressive form of the disease. “Kadcyla is an antibody-drug conjugate representing a completely new way to treat HER2-positive metastatic breast cancer, and it helped people in the EMILIA study live nearly six months longer,” said Hal Barron, M.D., chief medical officer and head, Global Product Development. “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.” Kadcyla is made up of the antibody, trastuzumab, and the chemotherapy, DM1, joined together using a stable linker. Kadcyla combines the mechanisms of action of both trastuzumab and DM1, and it is the first Genentech ADC approved by the FDA. Genentech has studied ADC science for more than a decade and has eight ADCs in Phase I or Phase II studies for different types of cancer. Kadcyla will be available to people in the United States within two weeks. As part of this approval, Genentech plans to initiate patient assistance programs for people taking Kadcyla through Genentech Access Solutions. These programs help people who might not be able to afford this medicine. People who do not have health insurance, or who have reached the lifetime limit set by their insurance company, might qualify to receive Kadcyla free of charge. For people with insurance, Genentech Access Solutions offers co-pay assistance programs to help with the out-of-pocket costs of their medicine, including a co-pay card for those with private insurance. The card pays 80 percent of out-of-pocket costs for people who qualify (up to $9,000 or $24,000 per year, depending on the person's income).