Genentech, a member of the Roche Group (RHHBY.PK), announced that the U.S. Food and Drug Administration or FDA has approved Kadcyla(ado-trastuzumab emtansine or T-DM1) for the treatment of people with HER2-positive metastatic breast cancer or mBC who have received prior treatment with Herceptin (trastuzumab) and a taxane chemotherapy.
Genentech said that 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, Genentech said.
Genentech noted that 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).
Breast cancer is the second leading cause of cancer-related death among women. An estimated 232,340 women will be diagnosed with breast cancer, and 39,620 will die from the disease in 2013, according to the National Cancer Institute. Almost 20 percent of breast cancers have increased amounts of the HER2 protein.
In a separate press release, ImmunoGen Inc. (IMGN) said that FDA approval of Kadcyla triggers a $10.5 million milestone payment to the company. The company also earns royalties on commercial sales of Kadcyla.
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