"Broader than Expected", First line should be $16+ soon
By Jennifer Corbett Dooren: The U.S. Food and Drug Administration Friday approved a powerful new type of drug that will be marketed by Roche Holding AG (ROG.VX, RHHBY) to treat breast cancer. The drug called, Kadcyla, combines Roche's existing cancer drug, Herceptin, with a powerful chemotherapy agent, and is meant to treat certain types of breast cancer that have spread to other parts of the body.
Herceptin targets a protein called HER2 found on tumors in about 20% to 25% of breast-cancer patients. The two other components of Kadcyla, both developed by ImmunoGen Inc. (IMGN), are a chemotherapy agent called emtansine that is too potent to be delivered as a conventional medicine, and a linker that connects the two drugs. Herceptin then delivers the package to the tumor cell, where it releases the toxic cargo to kill the cancer.
The FDA's approval of Kadcyla, which was previously known as T-DM1, triggers a $10.5 million payment to ImmunoGen by Roche. ImmunoGen will also receive royalties on sales of up to 5%.
Analysts said the approval was broader than expected. The drug can be marketed for initial treatment rather than just in patients who've tried other therapies, creating a "significantly larger patient population," said Simos Simeondis, an analyst at Cowen and Company.
Roche's Genentech unit said Kadcyla will be available to patients in about two weeks. The drug will be priced at $9,800 a month. The company said there will be a patient-assistance program to help pay for the product.