Sources: US Food & Drug Safety Administration; MedScape
Pertuzumab ( Perjeta, Genentech/Roche), has been approved in the United States. Perjeta targets HER2-positive breast cancer. About 1/4 of all cases of breast cancer are HER2-positive. It is indicated for use in patients with metastatic HER2-positive breast cancer who have not received previous treatment with either chemotherapy or HER2-targeted therapy. Pertuzumab is approved for use in combination with the first HER2 therapy ever launched, trastuzumab ( Herceptin, Genentech/Roche), and with the chemotherapy agent docetaxel. The approval, granted by the US Food and Drug Administration (FDA) after a priority review, is based on the results of the phase 3 CLEOPATRA (Clinical Evaluation of Pertuzumab and Trastuzumab) trial. A similar application is under review at the European Medicines Agency.
In the CLEOPATRA trial, the addition of pertuzumab significantly increased progression-free survival, compared with trastuzumab plus docetaxel (18.5 vs 12.4 months). “This is huge. It is very uncommon to have a clinical trial show this level of improvement in progression-free survival,” lead author José Baselga, MD, PhD, professor of medicine at Harvard Medical School and associate director of the Massachusetts General Cancer Center in Boston was quoted as saying.
“The results are better than imagined. This is a fairly robust improvement,” Harold Burstein, MD, from the Dana-Farber Cancer Institute in Boston, noted. He predicted that the 3-drug combination “is likely to become a standard of care in this setting.” The addition of pertuzumab to trastuzumab and docetaxel resulted in “only minimal side effects,” and the 3-drug combination was “remarkably safe and well tolerated,” Dr. Baselga explained. There was an increase in febrile neutropenia (48.9% vs 45.8%) and diarrhea of grade 3 or higher (7.9% vs 5.0%), but there was no increase in left ventricular systolic dysfunction (1.2% vs 2.8%).
When tested as a single agent early in its development, pertuzumab showed only modest antitumor activity; however, it demonstrated synergy when used with trastuzumab. Although both products are humanized monoclonal antibodies that stimulate antibody-dependent cell-mediated cytotoxicity, the 2 products bind at different points on HER2. Because they have slightly different mechanisms of action, the 2 agents together provide “a more comprehensive blockade of HER2 signaling and result in greater antitumor activity than either agent alone,” Dr. Baselga explained.
Genentech said it is working with the FDA to ensure a consistent manufacturing process and supply of the drug to patients who need it. The major downside we see? Pertuzumab costs $5900 per month or around $71,000 per year for the average patient. Yes, drugs cost money to research and trial and get to market, but still. Pharmaceutical industry analysts predict that the product will be just as successful as trastuzumab, which generated global sales of nearly $6 billion in 2011. Maybe a little less profit and a little more realism in costs would be in order.
If you or a loved one have been diagnosed with breast cancer which was misdiagnosed or diagnosed late, contact the Lewis Law Firm for a FREE consultation and review of your case, today. The Lewis Law Firm has a long history of representing women with breast cancer and their families in Philadelphia and New Jersey.