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Fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection plus chemotherapy in HER2-positive early breast cancer (FeDeriCa): a randomised, open-label, multicentre, non-inferiority, phase 3 study.
Tan AR, Im SA, Mattar A, Colomer R, Stroyakovskii D, Nowecki Z, De Laurentiis M, Pierga JY, Jung KH, Schem C, Hogea A, Badovinac Crnjevic T, Heeson S, Shivhare M, Kirschbrown WP, Restuccia E, Jackisch C; FeDeriCa study group. Tan AR, et al. Lancet Oncol. 2021 Jan;22(1):85-97. doi: 10.1016/S1470-2045(20)30536-2. Epub 2020 Dec 21. Lancet Oncol. 2021. PMID: 33357420 Clinical Trial.
BACKGROUND: A subcutaneous formulation of pertuzumab and trastuzumab with recombinant human hyaluronidase in one ready-to-use, fixed-dose combination vial (pertuzumab, trastuzumab, and hyaluronidase-zzxf) was approved by the US Food and Drug Administra …
BACKGROUND: A subcutaneous formulation of pertuzumab and trastuzumab with recombinant human hyaluronidase in one ready- …
Removal of interstitial hyaluronan with recombinant human hyaluronidase improves the systemic and lymphatic uptake of cetuximab in rats.
Styles IK, Feeney OM, Nguyen TH, Brundel DHS, Kang DW, Clift R, McIntosh MP, Porter CJH. Styles IK, et al. J Control Release. 2019 Dec 10;315:85-96. doi: 10.1016/j.jconrel.2019.10.040. Epub 2019 Oct 23. J Control Release. 2019. PMID: 31655131
Interstitial administration, however, is hindered by the presence of hyaluronan (HA), a glycosaminoglycan that is a major fluid barrier in the interstitial space. The transient removal of HA with recombinant human hyaluronidase (rHuPH20) helps facilitate the …
Interstitial administration, however, is hindered by the presence of hyaluronan (HA), a glycosaminoglycan that is a major fluid barrier in t …
Subcutaneous Trastuzumab: A Review in HER2-Positive Breast Cancer.
Heo YA, Syed YY. Heo YA, et al. Target Oncol. 2019 Dec;14(6):749-758. doi: 10.1007/s11523-019-00684-y. Target Oncol. 2019. PMID: 31686307 Review.
A subcutaneous (SC) formulation of trastuzumab, a potent humanized anti-Human Epidermal growth factor Receptor 2 (HER2) receptor monoclonal antibody, with a recombinant hyaluronidase (Herceptin Hylecta; Herceptin()) is indicated in the USA and EU for the trea …
A subcutaneous (SC) formulation of trastuzumab, a potent humanized anti-Human Epidermal growth factor Receptor 2 (HER2) receptor mono …
Population pharmacokinetic and exploratory exposure-response analysis of the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in patients with HER2-positive early breast cancer in the FeDeriCa study.
Wang B, Deng R, Hennig S, Badovinac Crnjevic T, Kaewphluk M, Kågedal M, Quartino AL, Girish S, Li C, Kirschbrown WP. Wang B, et al. Cancer Chemother Pharmacol. 2021 Sep;88(3):499-512. doi: 10.1007/s00280-021-04296-0. Epub 2021 Jun 9. Cancer Chemother Pharmacol. 2021. PMID: 34106303 Free PMC article. Clinical Trial.
CONCLUSION: The approved PH FDC SC dose [loading: 1200/600 mg pertuzumab/trastuzumab (15 mL); maintenance: 600 mg pertuzumab/trastuzumab (10 mL) and 2000 U/mL recombinant human hyaluronidase every 3 weeks] provides a positive benefit-risk profile with compara …
CONCLUSION: The approved PH FDC SC dose [loading: 1200/600 mg pertuzumab/trastuzumab (15 mL); maintenance: 600 mg pertuzumab/trastuzumab (10 …
Trastuzumab and thyroid dysfunction: An association to be aware of.
Sánchez-Bayona R, Garcia Del Barrio MA, Alegre E, Fernandez-Hidalgo OA, Eslava MS. Sánchez-Bayona R, et al. J Cancer Res Ther. 2022 Jul-Sep;18(4):1183-1185. doi: 10.4103/jcrt.JCRT_66_19. J Cancer Res Ther. 2022. PMID: 36149184 Free article.
Trastuzumab (T) is a humanized monoclonal antibody approved for human epidermal growth factor receptor 2 (HER2)-positive BC in the neoadjuvant, adjuvant, and metastatic scenarios. ...We report two cases of HER2-positive early BC patients who developed hypothyroidism during …
Trastuzumab (T) is a humanized monoclonal antibody approved for human epidermal growth factor receptor 2 (HER2)-positive BC in the ne …
Development of a Subcutaneous Fixed-Dose Combination of Pertuzumab and Trastuzumab: Results From the Phase Ib Dose-Finding Study.
Kirschbrown WP, Wynne C, Kågedal M, Wada R, Li H, Wang B, Nijem I, Badovinac Crnjevic T, Gasser H, Heeson S, Eng-Wong J, Garg A. Kirschbrown WP, et al. J Clin Pharmacol. 2019 May;59(5):702-716. doi: 10.1002/jcph.1362. Epub 2018 Dec 19. J Clin Pharmacol. 2019. PMID: 30570763 Free PMC article. Clinical Trial.
Adding pertuzumab to trastuzumab (both monoclonal antibodies targeting human epidermal growth factor receptor 2 [HER2]) has proven survival benefits when combined with chemotherapy for patients with HER2-positive breast cancer. ...This study aimed to identify an SC pertuzu …
Adding pertuzumab to trastuzumab (both monoclonal antibodies targeting human epidermal growth factor receptor 2 [HER2]) has proven su …
Clinical Immunogenicity of rHuPH20, a Hyaluronidase Enabling Subcutaneous Drug Administration.
Rosengren S, Dychter SS, Printz MA, Huang L, Schiff RI, Schwarz HP, McVey JK, Drake FH, Maneval DC, Kennard DA, Frost GI, Sugarman BJ, Muchmore DB. Rosengren S, et al. AAPS J. 2015 Sep;17(5):1144-56. doi: 10.1208/s12248-015-9782-0. Epub 2015 May 13. AAPS J. 2015. PMID: 25967925 Free PMC article.
Recombinant human PH20 hyaluronidase (rHuPH20) is used to facilitate dispersion of subcutaneously delivered fluids and drugs. This report summarizes rHuPH20 immunogenicity findings from clinical trials where rHuPH20 was co-administered with SC human im
Recombinant human PH20 hyaluronidase (rHuPH20) is used to facilitate dispersion of subcutaneously delivered fluids and