[1] O'Shaugnessy J, et al. Patient (pt) preference for the pertuzumab-trastuzumab fixed-dose combination for subcutaneous use (PH FDC SC) in HER2-positive early breast cancer (EBC): Primary analysis of the open-label, randomised crossover PHranceSCa study. Presented at ESMO, 2020 Sept 19-21. Abstract #165MO. [2] Xavier P, et al. Preference for subcutaneous or intravenous administration of trastuzumab in patients with HER2-positive early breast cancer (PrefHer): an open-label randomised study. Lancet Oncol. 2013;14(10):962-70. [3] Tjalma, et al. Trastuzumab IV versus SC: A time, motion and cost assessment in a lean operating day care oncology unit. Presented at: SABCS; 2016 Dec 6-10; San Antonio, TX, USA. Abstract #P4-21-15. [4] US Food and Drug Administration. Prescribing information for Phesgo. [Internet; cited December 2020]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761170s000lbl.pdf. [5] US Food and Drug Administration. Prescribing Information for Herceptin. [Internet; cited December 2020]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/. [6] US Food and Drug Administration. Prescribing information for Perjeta. [Internet; cited December 2020]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125409lbl.pdf. [7] Tan A. et al. Subcutaneous administration of the fixed-dose combination of trastuzumab and pertuzumab in combination with chemotherapy in HER2-positive early breast cancer: Primary analysis of the phase III, multicenter, randomized, open-label, two-arm FeDeriCa study. Presented at SABCS; 2019 Dec 10-14; San Antonio, Texas. Abstract #PD4-07. [8] Sripada et al. Subcutaneous fixed-dose combination of pertuzumab and trastuzumab for the treatment of metastatic breast cancer in Canada - a budget impact analysis. Presented at SABCS; 2020 Dec 08-11; San Antonio Texas: PS9-55. [9] Roche data on file. [10] Clinical trials.gov. A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Participants With HER2-Positive Early Breast Cancer (FeDeriCa). [Internet: December 2020]. Available from: https://clinicaltrials.gov/ct2/show/NCT03493854. [11] Halozyme. Enhanze(R) Drug Delivery Technology. [Internet; cited December 2020]. Available from: https://www.halozyme.com/enhanze/overview/default.aspx. [12] Iqbal N, Iqbal N. Human Epidermal Growth Factor Receptor 2 (HER2) in Cancers: Overexpression and Therapeutic Implications. Mol Biol Int. 2014;2014:852748. [13] Baselga J, Swain SM. Novel anticancer targets: revisiting ERBB2 and discovering ERBB3. Nat Rev Cancer 2009;9:463-75. [14] Gianni L, et al. Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial. Lancet Oncol. 2012;13(1):25-32. [15] Minckwitz G, et al. Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer. N Engl J Med. 2017;13;377(2):122-31. [16] Swain SM, et al. Pertuzumab, trastuzumab, and docetaxel in HER2-positive metastatic breast cancer. N Engl J Med. 2015;19;372(8):724-34. [17] Jarrett A, et al. Experimentally-driven mathematical modelling to improve combination targeted and cytotoxic therapy for HER2+ breast cancer. Sci Rep. 2019;9:12830. Roche Group Media Relations Phone: +41 61 688 8888 / e-mail: https://www.globenewswire.com/Tracker?data=-1jHfHsZsNiiBnXaKNpUgJvCJpIRJppO8mp72WmZXUpJ-sNkJdyAc1rNBQRTNyyUUPUew4epixwtD3ZFuQWnBtSXT-YvXrxfgwhmJZ45rFX8Jah67AOdNxprRSN_8pm- media.relations@roche.com Dr. Nicolas Dunant Patrick Barth Phone: +41 61 687 05 17 Phone: +41 61 688 44 86 Dr. Daniel Grotzky Karsten Kleine Phone: +41 61 688 31 10 Phone: +41 61 682 28 31 Nina Mählitz Nathalie Meetz Phone: +41 79 327 54 74 Phone: +41 61 687 43 05 Dr. Barbara von Schnurbein Phone: +41 61 687 89 67 Roche Investor Relations Dr. Karl Mahler Jon Kaspar Bayard Phone: +41 61 68-78503 Phone: +41 61 68-83894 e-mail: mailto:karl.mahler@roche.com e-mail: mailto:jon_kaspar.bayard@roche.com karl.mahler@roche.com jon_kaspar.bayard@roche.com -------------------------------------------- ------------------------------------------- Dr. Sabine Borngräber Dr. Bruno Eschli Phone: +41 61 68-88027 Phone: +41 61 68-75284 e-mail: mailto:sabine.borngraeber@roche.com e-mail: mailto:bruno.eschli@roche.com sabine.borngraeber@roche.com bruno.eschli@roche.com -------------------------------------------- ------------------------------------------- Dr. Birgit Masjost Dr. Gerard Tobin Phone: +41 61 68-84814 Phone: +41 61 68-72942 e-mail: mailto:birgit.masjost@roche.com e-mail: mailto:gerard.tobin@roche.com birgit.masjost@roche.com gerard.tobin@roche.com -------------------------------------------- ------------------------------------------- Investor Relations North America Loren Kalm Dr. Lisa Tuomi Phone: +1 650 225 3217 Phone: +1 650 467 8737 e-mail: mailto:kalm.loren@gene.com e-mail: mailto:tuomi.lisa@gene.com kalm.loren@gene.com tuomi.lisa@gene.com -------------------------------------------- ------------------------------------------- Attachment -- 23122020_MR_Phesgo EU approval https://ml-eu.globenewswire.com/Resource/Download/f3488fa0-1527-4b11-ac68-6443eb1a3767
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December 23, 2020 01:00 ET (06:00 GMT)