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Trastuzumab Continues to be Successful for HER2 Breast Cancer Patients

(Pub. 3rd July, 2012)

Approximately 15 to 25 percent of breast cancers are documented as an overexpression of the HER2 protein or an amplification of the HER2 gene. As a monoclonal antibody against human epidermal growth receptor 2 protein (HER2), trastuzumab has proven to be a reliable and efficacious treatment for women with breast cancer who have an overexpression of HER2.

Trastuzumab is useful in adjuvant therapy, alongside other established other chemotherapeutic agents, like anthracyclines, surgery and radiation treatment. How trastuzumab works is not entirely a mystery, as researchers have proposed several purported mechanisms of action for this FDA approved cancer drug. Previously recorded studies involving animal models of breast cancer have indicated that trastuzumab can inhibit over expression of growth factor through angiogenesis, therefore inducing normalization.

A new antibody found, pertuzumab, has shown itself to be even more effective than trastuzumab, as it binds farther down the molecule and inhibits it's dimerization. Several other studies have suggested that trastuzumab has effector cells which innately bring about antibody-dependent cytotoxicity.The efficacy of trastuzumab is valid nonetheless, as long term studies indicate that in an adjuvant setting the administration of trastuzumab in combination with or following chemotherapy improves the disease-free and overall survival rates in patients with early stage HER2 gene amplification breast cancer.

The future success in trastuzumab, also known by the brand name Herceptin, lies in the ability of researchers to utilize this potent drug through theranostics. Defined as as diagnostics which are closely tied to a specific drug treatment, scientists effectively develop molecular diagnostic tests in tandem with targeted therapeutics. A perfect example of the effectual use of theranostics is the HER2 test for patients, followed with treatment, if appropriate, with trastuzumab. This strategy of developing  both diagnostic tests and targeted therapeutics in a collaborative manner is essential for individualizing patient treatment. In the case of patients who displayed a specific disease subtype and genetic profile for the HER2 gene, the subsequent treatment with trastuzumab proved to be clinically superior to non individualized care. Genentech’s Herceptin and DakoCytomation’s HercepTest are reflective of the concept of theranostics for the treatment of breast cancer patients. Continued research and development is needed to ascertain novel cancer biomarkers and create new and effectual oncologic theranostics.

 Trastuzumab is not only a pivotal player in the future of oncologic theranostics, it is also a financial boon for the pharmaceutical industry. On June 13, 2012 PDL BioPharma Inc. reported a 4 percent sales growth for Herceptin in the first quarter of 2012.  Improvements in sales due to the increased use of genetic testing, or theranostics, for breast cancer treatments were cited for the increased revenue. Also cited was the use of Herceptin's developing in countries, such as Latin America and the Asia-Pacific region countries. In addition, trastuzumab is also now approved by the FDA to treat adenocarcinoma of the stomach or gastroesophageal junction. A substantial 125 million dollar revenue is expected from the second quarter combination of sales from Herceptin, the eye drug Lucentis, and the multiple sclerosis drug Tysabri, as reported by PDL BioPharma.

 Trastuzumab is typically dosed based on height, weight,  patient health and the type of cancer being treated.  It is dispensed  by administering an infusion into the vein via an intravenous IV. The first dose is usually given over 90 minutes, and if it is well-tolerated by the patient subsequent maintenance doses may be given. The European Breast Cancer Conference 2008 reported favorable results from long term studies which combined trastuzumab with standard chemotherapy prior to breast cancer surgery in women with HER2-positive early breast cancer. Complete eradication of tumors occurred in 45.5 percent of these women, surprising even investigators, like Prof. Dr. von Minckwitz of the University Women's Hospital in Frankfurt, Germany. Dr. von Minckwitz, who is also the Managing Director of the German Breast Group declared this study, deemed GeparQuattro a triumph for researchers, practitioners and patients. Hope is on the horizon for patients being treated with trastuzumab.

YES Pharma is proud to be a leading supply source for Trastuzumab API to several global pharmaceutical companies and academic research institutes, while recognizing that we play a significant part in promoting the struggle against cancer. The Trastuzumab that YES Pharma supplies is intended for laboratory R&D use only.

References:

GATE clinical appraisal of Herceptin Trials
HER2 therapy, US National Library of Medicine/National Institutes of Health
Sci Clips, January 8, 2012
PDL BioPharma Inc. Via Associated Press, 6/13/12
European Breast Cancer Conference 2008
GeparQuattro Study
 

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Dun and Bradstreet