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:
- The risk of death decreased by 34 percent for patients who received the combination of Perjeta, Herceptin, and chemotherapy compared to those who received Herceptin and chemotherapy.
- For people who had Herceptin and chemotherapy the overall median survival was 37.6 months. The median survival for the patients using Perjeta was not yet reached at the time of this analysis because over half of the participants continued to survive.
- Patients who received Perjeta, Herceptin and chemotherapy had a significant drop in the risk of their cancer worsening or death compared to those who only received Herceptin and chemotherapy.
- The median progression free survival increased by 6.1 months from 12.4 months for people who received Herceptin and chemotherapy to 18.5 months for those who received the combination Perjeta, Herceptin and chemotherapy.
- The most frequently seen side effects that appeared with the combination of Perjeta, Herception and chemotherapy were:
-low white blood cell count