The FDA approved new breast cancer drug developed by Roche/Genentech on Friday. The drug marketed under the name Perjeta, (generic: Pertuzumab) is specific for women with HER 2 positive breast cancer.
The tumors of these women have high levels of HER2 protein molecules. Pertuzumab binds with HER2 receptor molecules and prevent their dimerization, a process which leads to tumor growth and proliferation. Pertuzumab-HER2 molecules signal body’s immune mechanism to destroy cancer cells. Perjeta and Herceptin (Trastuzumab) complements each other in their actions by binding to different regions of the HER2 receptors bringing about their destruction. It is believed that a combination of Pertuzumab, Trastuzumab, and chemotherapy would disrupt the HER2 signaling pathways.
Trastuzumab/Herceptin is the current standard therapy for breast cancer. Tastuzumab binds to HER2 proteins and inhibits cell growth and replication. However, over the course of time, patients become immune to the drug. Pertuzumab/ Perjeta in combination with Trastuzumab offered more complete blockage of HER2 signaling pathways.
Promising results of early clinical trial of Pertuzumab, forced the FDA to review the results in 6 months rather than the usual 10 months.
The trial involved 808 breast cancer patients with tumor that had spread to other parts of the body. Clinical trial results showed that group of women on Pertuzumab, Herceptin, and Taxotere exhibited an extended period of median of 6.2 months of progression free survival when compared to the group on Herceptin and Taxotere alone. In addition, a combination of Herceptin and Pertuzumab seemed to bring about a 38% reduction in risk of disease worsening or death. The trial is underway and overall survival rates are yet to come by.
The combination along with chemotherapy will prolong worsening of the tumor than when Herceptin alone is administered.
The drug, Perjeta would be made available in the market in a matter of two weeks and would cost about $5,900/month, said officials from Genentech.
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