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Enfortumab vedotin after PD-1 or PD-L1 inhibitors in cisplatin-ineligible patients with advanced urothelial carcinoma (EV-201): a multicentre, single-arm, phase 2 trial.
Yu EY, Petrylak DP, O'Donnell PH, Lee JL, van der Heijden MS, Loriot Y, Stein MN, Necchi A, Kojima T, Harrison MR, Hoon Park S, Quinn DI, Heath EI, Rosenberg JE, Steinberg J, Liang SY, Trowbridge J, Campbell M, McGregor B, Balar AV. Yu EY, et al. Lancet Oncol. 2021 Jun;22(6):872-882. doi: 10.1016/S1470-2045(21)00094-2. Epub 2021 May 12. Lancet Oncol. 2021. PMID: 33991512 Clinical Trial.
METHODS: EV-201 is a multicentre, single-arm, phase 2 study of enfortumab vedotin in patients with locally advanced or metastatic urothelial carcinoma previously treated with PD-1 or PD-L1 inhibitors. ...Efficacy and safety were analysed in all patient …
METHODS: EV-201 is a multicentre, single-arm, phase 2 study of enfortumab vedotin in patients with locally advan …
Pivotal Trial of Enfortumab Vedotin in Urothelial Carcinoma After Platinum and Anti-Programmed Death 1/Programmed Death Ligand 1 Therapy.
Rosenberg JE, O'Donnell PH, Balar AV, McGregor BA, Heath EI, Yu EY, Galsky MD, Hahn NM, Gartner EM, Pinelli JM, Liang SY, Melhem-Bertrandt A, Petrylak DP. Rosenberg JE, et al. J Clin Oncol. 2019 Oct 10;37(29):2592-2600. doi: 10.1200/JCO.19.01140. Epub 2019 Jul 29. J Clin Oncol. 2019. PMID: 31356140 Free PMC article. Clinical Trial.
METHODS: EV-201 is a global, phase II, single-arm study of enfortumab vedotin 1.25 mg/kg (intravenously on days 1, 8, and 15 of every 28-day cycle) in patients with locally advanced or metastatic urothelial carcinoma who were previously treated with pl …
METHODS: EV-201 is a global, phase II, single-arm study of enfortumab vedotin 1.25 mg/kg (intravenously on days …
Health-related Quality of Life of Patients with Locally Advanced or Metastatic Urothelial Cancer Treated with Enfortumab Vedotin after Platinum and PD-1/PD-L1 Inhibitor Therapy: Results from Cohort 1 of the Phase 2 EV-201 Clinical Trial.
McGregor B, O'Donnell PH, Balar A, Petrylak D, Rosenberg J, Yu EY, Quinn DI, Heath EI, Campbell M, Hepp Z, McKay C, Steinberg J, Regnault A, Mazerolle F, Galsky MD. McGregor B, et al. Eur Urol. 2022 May;81(5):515-522. doi: 10.1016/j.eururo.2022.01.032. Epub 2022 Feb 12. Eur Urol. 2022. PMID: 35168844 Free PMC article. Clinical Trial.
BACKGROUND: The EV-201 trial (NCT03219333) demonstrated a clinically meaningful and durable response rate and a tolerable safety profile with enfortumab vedotin (EV) in patients with locally advanced/metastatic urothelial carcinoma (LA/mUC) treated wit …
BACKGROUND: The EV-201 trial (NCT03219333) demonstrated a clinically meaningful and durable response rate and a tolerable safe …
Enfortumab vedotin-related pneumonitis is more common than expected and could lead to acute respiratory failure.
Yoon S, Shin SJ, Kim HC, Kim YS, Lee HJ, Keam B, Choi YJ, Kim YJ, Park I, Park SH, Lee JL. Yoon S, et al. Eur J Cancer. 2022 Oct;174:81-89. doi: 10.1016/j.ejca.2022.07.014. Epub 2022 Aug 16. Eur J Cancer. 2022. PMID: 35985251
PURPOSE: To analyse the incidence of pneumonitis related to enfortumab vedotin (EV) in patients with metastatic urothelial cell carcinoma (mUC). ...RESULTS: Between October 2018 and January 2020, 64 patients were enrolled in the EV-201 and EV-301 trial …
PURPOSE: To analyse the incidence of pneumonitis related to enfortumab vedotin (EV) in patients with metastatic urothelial cel …
Advancements in Therapy for Bladder Cancer: Enfortumab Vedotin.
Hanna KS. Hanna KS. J Adv Pract Oncol. 2020 May-Jun;11(4):412-417. doi: 10.6004/jadpro.2020.11.4.8. Epub 2020 May 1. J Adv Pract Oncol. 2020. PMID: 33604101 Free PMC article.
Food & Drug Administration for patients with advanced or metastatic UC following chemotherapy and immunotherapy. Approval of enfortumab vedotin was based on findings from the EV-201 trial, which demonstrated objective response rates of 44%. ...In t …
Food & Drug Administration for patients with advanced or metastatic UC following chemotherapy and immunotherapy. Approval of enfortum …
FDA Approval Summary: Enfortumab Vedotin for Locally Advanced or Metastatic Urothelial Carcinoma.
Chang E, Weinstock C, Zhang L, Charlab R, Dorff SE, Gong Y, Hsu V, Li F, Ricks TK, Song P, Tang S, Waldron PE, Yu J, Zahalka E, Goldberg KB, Pazdur R, Theoret MR, Ibrahim A, Beaver JA. Chang E, et al. Clin Cancer Res. 2021 Feb 15;27(4):922-927. doi: 10.1158/1078-0432.CCR-20-2275. Epub 2020 Sep 22. Clin Cancer Res. 2021. PMID: 32962979
On December 18, 2019, the FDA granted accelerated approval to enfortumab vedotin-ejfv (PADCEV; Astellas and Seattle Genetics) for treatment of patients with locally advanced or metastatic urothelial cancer who have previously received a programmed cell death protein …
On December 18, 2019, the FDA granted accelerated approval to enfortumab vedotin-ejfv (PADCEV; Astellas and Seattle Genetics) …