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Kadcyla Wins FDA Approval For HER2 Breast Cancer

By February 27, 2013

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A new drug will soon be available to treat HER2-positive metastatic breast cancer. Made by Genentech, it will be known as Kadcyla (ado-trastuzumab emtansine). This drug is a highly targeted therapy that has been tested in clinical trials and found to extend the life of patients with advanced disease, while limiting unwanted side effects.

There are several drugs now used for HER2 breast cancer, the most familiar of which is Herceptin (trastuzumab), which was given FDA approval six years ago.  Kadcyla is a double-threat to HER2 positive cancer cells, because it combines Herceptin with a chemo drug called DM1. Given as part of an infusion, Kadcyla uses Herceptin to seek out only HER2 cancer cells and then give them DM1 to kill them. This type of targeted therapy - since it bypasses healthy cells that don't need chemo - causes less side effects while selectively poisoning just the cancer.

Kadcyla was tested on 991 patients with HER2-positive metastatic breast cancer who had already been treated with Herceptin and a taxane chemotherapy. The study, which has passed Phase III testing, was called EMILIA and was an international clinical trial. Patients in the study either took Kadcyla or two other standard treatments given for HER2-positive breast cancer. This drug helped many patients live 6 months longer than those taking lapatinib and Xeloda. While patients did have side effects, including lower blood counts, low potassium, neuropathy and fatigue, the majority of people tolerated the drug well.

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Comments
April 6, 2013 at 5:31 pm
(1) Lois Taylor says:

My husband has gastric cancer. He is Her2 pos and he has reaped
the rewards from Herceptin. NOW we find out that the FDA has only
approved Kadcyla for breast cancer. The rest of the cancers should
look for the “Ice Float”.? Politics, politics!!!

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