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Kadcyla Approval

Posted 2/28/2013

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  This is big news. It is especially important news for women who have her2positive breast cancer. Feeling somewhat like a broken record, let me repeat the reality that much/most research is directed at finding targeted treatments that are effective for specific kinds of cancer cells. The discovery of herceptin changed the whole world of treatment for women with her2 positive breast cancers. What had been a particularly lethal form of the disease became one that was at least as treatable as any other. Many, many women have benefitted from herceptin and have been treated, gone on to stay strong and healthy without a breast cancer recurrence. The FDA announced this week that another drug to treat her2 positive disease, Kadcyla, has been approved.

  I have known a number of women with advanced breast cancer who have been on clinical trials with Kadcyla, called TDM-1 in the trials. They have all done well, and one woman's cancer has seemingly vanished. When she has scans, they now find no evidence of metasteses. The most exciting scientific part of Kadcyla is how it works; it delivers chemotherapy to the tumor, providing a way to transit, as it were, for drugs that otherwise could not get there. The expectation is that this break through will be explored and expanded to include a similar system for the targeted delivery of other chemotherapy drugs for all kinds of cancers.

  No one discovery or drug cures cancer. In fact, each new treatment extends life or disease free recurrence time by months--in this case, by an average of eight months. The hope is that each builds on every other possibility, and that the time lengthens and lengthens. Here is the beginning of the FDA statement and then a link:

FDA approves new treatment for late-stage breast cancer

En Español1

The U.S. Food and Drug Administration today approved Kadcyla (ado-trastuzumab emtansine), a new therapy for patients with HER2-positive, late-stage (metastatic) breast cancer.

HER2 is a protein involved in normal cell growth. It is found in increased amounts on some types of cancer cells (HER2-positive), including some breast cancers. In these HER2-positive breast cancers, the increased amount of the HER2 protein contributes to cancer cell growth and survival.

Kadcyla is intended for patients who were previously treated with trastuzumab, another anti-HER2 therapy, and taxanes, a class of chemotherapy drugs commonly used for the treatment of breast cancer.

“Kadcyla is trastuzumab connected to a drug called DM1 that interferes with cancer cell growth,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Kadcyla delivers the drug to the cancer site to shrink the tumor, slow disease progression and prolong survival. It is the fourth approved drug that targets the HER2 protein.”

Referred to as T-DM1 during clinical research, Kadcyla was reviewed under the FDA’s priority review program, which provides for an expedited six-month review of drugs that may provide safe and effective therapy when no satisfactory alternative therapy exists, or offer significant improvement compared to marketed products. Other FDA-approved drugs used to treat HER2-positive breast cancer include trastuzumab (1998), lapatinib (2007) and pertuzumab (2012).

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm340704.htm?source=govdelivery

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