The European Medicines Agency Review of Pertuzumab for the treatment of adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer: summary of the scientific assessment of the committee for medicinal products for human use
| Autor: | Boix-Perales, Hector, Borregaard, Jeanett, Jensen, Kristina Bech, Ersbøll, Jens, Galluzzo, Sara, Giuliani, Rosa, Ciceroni, Cinzia, Melchiorri, Daniela, Salmonson, Tomas, Bergh, Jonas, Schellens, Jan H, Pignatti, Francesco, Sub Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology |
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| Přispěvatelé: | Sub Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology |
| Jazyk: | angličtina |
| Rok vydání: | 2014 |
| Předmět: |
Oncology
Regulatory Issues: EMA Cancer Research medicine.medical_specialty medicine.medical_treatment ricerca clinica Breast Neoplasms breast cancer pertuzumab european medicines agency ema perjeta Antibodies Monoclonal Humanized Breast cancer Trastuzumab EMA Internal medicine Antineoplastic Combined Chemotherapy Protocols European Medicines Agency medicine media_common.cataloged_instance Humans European Union Summary of Product Characteristics European union skin and connective tissue diseases neoplasms media_common Chemotherapy Pertuzumab business.industry Perjeta Middle Aged medicine.disease Rash Survival Analysis Surgery Docetaxel Female medicine.symptom Neoplasm Recurrence Local business medicine.drug |
| Zdroj: | Oncologist, 19(7), 766. AlphaMed Press |
| ISSN: | 1083-7159 |
| Popis: | Pertuzumab is a recombinant humanized monoclonal antibody that specifically targets the extracellular dimerization domain (subdomain II) of HER2. Based on the positive opinion from the European Medicines Agency (EMA) on March 4, 2013, a marketing authorization valid throughout the European Union (EU) was issued for pertuzumab (Perjeta) for use in combination with trastuzumab and docetaxel for the treatment of adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease. The demonstration of clinical benefit for pertuzumab was based on a single, phase III, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of pertuzumab plus trastuzumab plus docetaxel versus placebo plus trastuzumab plus docetaxel in previously untreated patients with locally advanced or metastatic HER2-positive breast cancer. In the primary analysis, median progression-free survival was 18.5 months in the pertuzumab group compared with 12.4 months in the placebo group (hazard ratio [HR]: 0.62; 95% confidence interval [CI]: 0.51–0.75; p < .0001). For the secondary endpoints, overall survival (HR: 0.66; 95% CI: 0.52–0.84; p = .0008) and objective response rate (80.2% vs. 69.3%) were also favored in the pertuzumab group. Toxicity was similar between groups except for higher incidence of diarrhea, rash, mucosal inflammation, dry skin, and neutropenia for pertuzumab compared with placebo. This paper summarizes the scientific review of the application leading to approval in the EU. The detailed scientific assessment report and product information, including the summary of product characteristics, are available on the EMA website (http://www.ema.europa.eu). |
| Databáze: | OpenAIRE |
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