Guidelines

Is trastuzumab an antibody?

Is trastuzumab an antibody?

Trastuzumab (Herceptin, Genentech, Inc., South San Francisco, California) is a highly purified recombinant DNA-derived humanized monoclonal immunoglobulin G1 kappa antibody that binds with high affinity and specificity to the extracellular domain of the HER2 receptor.

Is Ado trastuzumab a monoclonal antibody?

Ado-trastuzumab emtansine contains a monoclonal antibody called trastuzumab that binds to a protein called HER2, which is found on some breast cancer cells. It also contains an anticancer drug called DM1, which may help kill cancer cells.

Is trastuzumab a biologic?

Herceptin (chemical name: trastuzumab) is a monoclonal antibody, a targeted therapy medicine used to treat HER2-positive breast cancers. Herceptin is what’s called a “biologic” drug. This means that it is made from living organisms, in this case a protein from a mouse cell.

What is the conjugate name for trastuzumab emtansine?

Because the monoclonal antibody targets HER2, and HER2 is only over-expressed in cancer cells, the conjugate delivers the cytotoxic agent DM1 specifically to tumor cells. The conjugate is abbreviated T-DM1 .

When was ado-trastuzumab emtansine approved by the FDA?

In 2013, ado-trastuzumab emtansine was approved in the United States for the treatment of adults with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Referred to as T-DM1 during clinical research, ado-trastuzumab emtansine was reviewed under the FDA’s priority review program.

How is the maleimide moiety of trastuzumab linked to DM1?

The succinimide group of SMCC reacts with the free amino group of a lysine residue in the trastuzumab molecule and the maleimide moiety of SMCC links to the free sulfhydryl group of DM1, forming a covalent bond between the antibody and the DM1. Each trastuzumab molecule may be linked to zero to eight DM1 molecules (3.5 on average).

What is the average life span of trastuzumab emtansine?

The median overall survival was 30.9 months in the ado-trastuzumab emtansine group and 25.1 months in the lapatinib plus capecitabine group. The U.S. Food and Drug Administration (FDA) approved ado-trastuzumab emtansine in February 2013, and granted the application for Kadcyla to Genentech.