The drug was given a positive opinion from the Committee of Medicinal Products for Human Use (CHMP), which is a recommendation for marketing authorization. The next step is actual approval from the European Commission.
Pertuzumab was approved in the United States earlier this year, costing approximately $188,000.
The indication for its use is rather narrow. Pertuzumab, a humanized monoclonal antibody directed against HER2, is indicated for use with the first available HER2-targeted agent trastuzumab (Herceptin, Roche), as well as docetaxel, in patients with metastatic or locally recurrent unresectable HER2-positive breast cancer who have not received previous HER2 therapy or chemotherapy for their metastatic disease.
According to the CHMP, the benefits of pertuzumab are its ability to improve progression-free survival, overall survival, and objective response rate, compared with placebo.
These benefits were demonstrated in the phase 3 CLEOPATRA (Clinical Evaluation of Pertuzumab and Trastuzumab) trial, first reported at the San Antonio Breast Cancer Symposium in 2011, as reported at the time by Medscape Medical News, and later published in the New England Journal of Medicine (2012;366:109-119).
The drug is expected to be expensive, which could cause problems with reimbursement in European countries. In the United States, double HER2 treatment with pertuzumab plus trastuzumab costs about $180,000 per course of therapy.
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Cite this: Pertuzumab for Breast Cancer Cleared for EU Approval - Medscape - Dec 14, 2012.