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Herceptin, INN-Trastuzumab 27 June 2013 EMA/CHMP/751770/2012/corr1 Committee for Medicinal Products for Human Use (CHMP) CHMP assessment report Herceptin International non-proprietary name trastuzumab Procedure No. EMEA/H/C/000278 Note Variation assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. 7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7455 E -mail [email protected] Website www.ema.europa.eu An agency of the European Union Product information Name of the medicinal product: Herceptin Applicant: Roche Registration Ltd. 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom Active substance: trastuzumab International Nonproprietary Name/Common Name: trastuzumab Pharmaco-therapeutic group Monoclonal antibodies (ATC Code): (L01XC03) Therapeutic indications: Breast Cancer Metastatic Breast Cancer (MBC) Herceptin is indicated for the treatment of patients with HER2 positive metastatic breast cancer: - as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments. - in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable. - in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease. - in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive metastatic breast cancer, not previously treated with trastuzumab. Early Breast Cancer (EBC) Herceptin is indicated for the treatment of patients with HER2 positive early breast cancer. Herceptin CHMP assessment report Page 2/70 - following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable). - following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel. - in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin. - in combination with neoadjuvant chemotherapy followed by adjuvant Herceptin monotherapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter. Herceptin should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay. Pharmaceutical form: Solution for injection Strength: 600 mg / 5 mL Route of administration: Subcutaneous use Packaging: vial (glass) Package size: 1 vial Herceptin CHMP assessment report Page 3/70 Table of contents 1. Background information on the procedure .............................................. 7 1.1. Submission of the dossier ...................................................................................... 7 1.2. Manufacturers ...................................................................................................... 8 1.3. Steps taken for the assessment of the product ......................................................... 8 2. Scientific discussion ................................................................................ 9 2.1. Introduction......................................................................................................... 9 2.2. Quality aspects .................................................................................................. 10 2.2.1. Introduction .................................................................................................... 10 2.2.2. Active Substance ............................................................................................. 10 2.2.3. Finished Medicinal Product ................................................................................ 12 2.2.4. Discussion on chemical, pharmaceutical and biological aspects .............................. 15 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects ...................... 15 2.2.6. Recommendations for future quality development................................................ 16 2.3. Non-clinical aspects ............................................................................................ 16 2.3.1. Introduction .................................................................................................... 16 2.3.2. Pharmacology ................................................................................................. 17 2.3.3. Pharmacokinetics............................................................................................. 21 2.3.4. Toxicology ...................................................................................................... 25 2.3.5. Ecotoxicity/environmental risk assessment ......................................................... 29 2.3.6. Discussion on non-clinical aspects...................................................................... 29 2.3.7. Conclusion on the non-clinical aspects ................................................................ 31 2.4. Clinical aspects .................................................................................................. 31 2.4.1. Introduction .................................................................................................... 31 2.4.2. Pharmacokinetics............................................................................................. 32 2.4.3. Discussion on clinical pharmacology ................................................................... 39 2.4.4. Conclusions on clinical pharmacology ................................................................. 40 2.5. Clinical efficacy .................................................................................................. 41 2.5.1. Dose response study(ies) ................................................................................. 41 2.5.2. Main study(ies) ............................................................................................... 41 2.5.3. Discussion on clinical efficacy ............................................................................ 50 2.5.4. Conclusions on the clinical efficacy ..................................................................... 51 2.6. Clinical safety ................................................................................................. 51 2.6.1. Discussion on clinical safety .............................................................................. 61 2.6.2. Conclusions on the clinical safety ....................................................................... 62 2.7. Pharmacovigilance .............................................................................................. 62 2.8. User consultation ............................................................................................... 66 3. Benefit-Risk Balance ............................................................................ 66 4. Recommendations ............................................................................... 69 Herceptin CHMP assessment report Page 4/70 List of abbreviations ADA anti-drug antibody ADCC antibody-dependent cellular cytotoxicity AE adverse events ALT alanine aminotransferase APB aminophenyl boronate AS active substance AUC area under the serum concentration time curve CE capillary electrophoresis CHF congestive heart failure CHO Chinese Hamster Ovary CHT ceramic hydroxyapatite CI confidence interval CL clearance Cmax maximum serum concentration CPPs critical process parameters CRM critical raw materials Ctrough minimum serum concentration DFS disease-free survival DoE Design of Experiments EBC early breast cancer ECG electrocardiography ECLIA electrochemiluminescence immunoassay EFS event-free survival ELISA enzyme-linked immunosorbent assay EMEA European Medicines Evaluation Agency EoP end of production EPP efficacy per-protocol population ER estrogen receptor ET enzyme titer EVAM ethylene vinylacetate copolymer, monomaterial FMEA Failure Mode and Effects Analysis FEC 5-fluorouracil, epirubicin, cyclophosphamide FP Finished product HCP Host cell protein HCP Health Care Provider HER2 human epidermal growth factor receptor 2 HPAEC-PAD High-Performance Anion-Exchange Chromatography with pulsed amperometric detection IBC inflammatory breast cancer ICH International Conference on Harmonization IE-HPLC Ion-Exchange High Performance Liquid Chromatography IHC immunohistochemistry IPC in-process control IRR infusion related reaction ISH in-situ hybridization ITT intent-to-treat population IV intravenous IVAC integral viable accumulated cells JP Japanese Pharmacopoeia LC-ESI/MS Liquid Chromatography coupled with Electrospray Ionization/Mass Spectrometry LRVs log reduction values LVEF left ventricular ejection fraction LVSD left ventricular systolic dysfunction Herceptin CHMP assessment report Page 5/70 MAH Marketing Authorization Holder MBC metastatic breast cancer MCB Master Cell Bank MHRA Medicines and Health products Regulatory Agency MUGA multigated acquisition scan NCCN National Comprehensive Cancer Network ORR overall response rate OS overall survival pCR pathological complete response PEI Paul Ehrlich Institute PFA perfluoroalkoxy PFS progression-free
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