Roche's Breast Cancer Drug Perjeta Receives Green Light From EUMain Category: Breast Cancer
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 15 Dec 2012
Today, Roche declared that the European Union gave a positive recommendation for the use of Perjeta (pertuzumab) in combination with Herceptin (trastuzumab) and docetaxel in patients with HER2-positive metastatic or location specific recurrent breast cancer that cannot be removed with surgery. This announcement verifies a suggestion for people with this certain type of cancer who have not yet received anti-HER2 therapy or chemotherapy for their cancer.
The positive recommendation was based on overall survival and progression-free survival data from the phase III CLEOPATRA study. The most recent survival outcomes reported at the 2012 CTR-AACR San Antonio Breast Cancer Symposium revealed that the risk of death decreased by 34 percent for patients who received the Perjeta combination. Hal Barron, MD, Roche's Chief Medical Officer and Head of Global Product Development said:
"The CHMP positive opinion for Perjeta brings us a significant step closer to the approval of a new personalized medicine for people with this aggressive form of breast cancer. Perjeta complements Herceptin in attacking HER2-positive tumors and we believe Perjeta will transform the way people with HER2-positive metastatic breast cancer are treated."
Perjeta is an individual medicine that focuses on the HER2 receptor, a protein found in increased quantities on the outside of cells in HER2-positive cancers. Perjeta is known to function in a way that complements Herceptin, while the two medicines focus on separate regions on the HER2 receptor.
The U.S. Food and Drug Administration approved Perjeta in combination with Herceptin and docetaxel chemptherapy for the treatment of patients with HER2-positive mBC, who have not had any anti-HER2 therapy or chemotherapy for metastatic disease in June of 2012.
Genetech, this week submitted a supplemental Biologics License Application (sBLA) to the FDA for the updated overall survival outcomes to be included in the Perjeta label. Perjeta was also approved by Swissmedic in August of this year, and in Mexico in September of 2011.
What is Perjeta?Perjeta is made specifically to prevent the HER2 receptor from combining with other HER receptors (EGFR/HER1, HER3, and HER4) on top of the cells, a process that is thought to contribute to tumor growth and lifespan. Binding of Perjeta to HER2 could also trigger the body's immune system to kill the cancer cells. Chemotherapy, Herceptin, and Perjeta combined are believed to give a more comprehensive barrier of HER signaling pathways.
About the CLEOPATRA StudyCLEOPATRA (Clinical Evaluation of Pertuzumab and TRAstuzumab) is a worldwide, phase III, double-blind, randomized, placebo-controlled study. The study measured the efficacy and safety of Perjeta in combination with docetaxel chemotherapy and Herceptin compared to Herceptin, chemotherapy plus a placebo. It consisted of 808 people with priorly untreated HER2-positive mBC or that come back after earlier treatment in the before or after surgery settings.
The study reached its first endpoint of progression free survival and its secondary stage of overall survival. The study results revealed:
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