February 22, 2013 | By Márcio Barra
This just in, today the FDA approved Kadcyla (ado-trastuzumab emtansine, or T-DM1), from Roche/Genentech. Kadcyla is a therapy for patients with HER2-positive, late-stage (metastatic) breast cancer, and it consists of an antibody, trastuzumab, connected to a drug called DM1.
HER2 is a protein encoded by ERBB2, a proto-oncogene located in chromosome 17. Over-expression of this proto-oncogene occurs in roughly 30% of breast cancers, and the increased amount of HER2 protein contributes to the breast cancer cell growth and survival.
The way Kadcycla works is quite novel. The antibody, trastuzumab, is linked to the chemotherapy agent, DM1 (or mertansine) through a stable linker. The antibody essentially delivers the chemotherapy agent directly to the cell growth protein HER2.
As it was designed for late-stage breast cancer, this drug is only intended for HER-2 positive patients that have not responded to trastuzumab or chemotherapy alone. Clinical trials show that patients survived a median of 30.9 months, as opposed to 25.1 months with the alternative treatment, lapatinib plus capecitabine.
This drug was approved under the FDA’s priority review program, a six month review process for drugs that provide safety and effective therapy when no other therapy exists, or offers a significant improvement compared to already existing products in the market.