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Verdye approval for Breast SLN\u00a0across Europe\u00a0including Austria, Belgium, Croatia, Czechia, Denmark, Finland, Greece, Hungary, Ireland, Italy, Netherlands, Poland, Portugal, Romania, Slovenia, Sweden and the UK. Verdye has previously been approved for the breast SLN indication in Spain.<\/strong><\/p> The presence of lymphatic metastases<\/a> is an important prognostic factor for the survival of breast cancer patients and their identification has a bearing on further treatment.1<\/sup> Sentinel lymph node biopsy (SLNB) remains a cornerstone in the management of early breast cancer and is the current standard of care for clinically and radiologically node-negative patients.2<\/sup><\/p> Importantly, SLNB enhances patient\u2019s quality of life without compromising diagnostic accuracy or prognostic information for node-negative patients.3<\/sup> Until recently, the gold standard for SLNB in patients with breast cancer is radio-guided surgery with radioisotope<\/a> technetium-99m (99mTc) which has a reported sentinel lymph node (SLN) detection rate of 86.4%.4<\/sup> Some clinicians combine 99mTc with blue dyes such as Methylene Blue dye<\/a>, increasing the detection rate to 96%-99.8%.4<\/sup> However, both 99mTc and blue dyes have many associated adverse effects.5,6<\/sup> In particular, Methylene Blue dye is associated with many devastating effects including soft tissue necrosis, (permanent) skin tattooing at the injection site, metabolic and haematologic side effects making it infrequently utilised for routine surgical care.7<\/sup> Further, Patent Blue and Isosulphan Blue are associated with increased rates of adverse reactions (0.7% – 1.1% of cases) in comparison to Methylene Blue.8,9<\/sup> Also, the use of 99mTc imposes a significant burden on patients and hospitals, including the logistical challenges associated with pre-operative administration, risk of exposure to ionising radiation for healthcare professionals, and adherence to regulatory requirements for handling and storage of radio-pharmaceuticals.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t Table 1: Compiled results from eight meta-analysis<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t *Based on Diagnostic Green Pharmacovigilance data, a single adverse reaction was identified in 22,248 patients.\u201d<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t A review of eight meta-analyses from 2016-2021 was undertaken, with results shown in Table 2, with a summary of compiled results in Table 3 and Table 4.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t Table 2: Results of eight meta-analyses: 2016-202110<\/sup><\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t Table 3: Compiled results from eight meta-analysis<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t Table 4: Compiled results from eight meta-analyses: 2016-2021<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t ICG-fluorescence (ICG-F) is clearly superior<\/strong> to blue dye (BD) staining in every metric of SLN detection<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t ICG-F is clearly non-inferior<\/strong> to both radioisotope (RI)-lymphoscintigraphy and the combination of RI + BD in per-case SLN detection and both per-case and per-node sensitivity\/false negative rate (FNR)<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t ICG-F is clearly superior<\/strong> to both RI and RI+BD in per-node SLN detection<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t The above-noted findings remain consistent with other published meta-analyses<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\n \n
\n <\/th>\n ICG<\/th>\n RI 99mTc<\/th>\n BD [9]<\/sup><\/th>\n <\/tr>\n <\/thead>\n \n \n Allergic reactions<\/td>\n Very rare (>1 \/
10,000)<\/td>\n Generalized erythema,
urticaria, angioedema<\/td>\n Soft tissue necrosis, metabolic,
and hematologic side effects<\/td>\n <\/tr>\n \n Dosing<\/td>\n During surgery<\/td>\n Day before<\/td>\n During Surgery<\/td>\n <\/tr>\n \n SLN detection rates<\/td>\n 96.1%<\/td>\n 86.4%<\/td>\n 85.7%<\/td>\n <\/tr>\n \n Radiation exposure<\/td>\n None<\/td>\n Yes<\/td>\n None<\/td>\n <\/tr>\n \n Resource use<\/td>\n High<\/td>\n Low<\/td>\n High<\/td>\n <\/tr>\n <\/tbody>\n<\/table>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t Significant benefits of using Verdye (ICG)<\/h2>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\n \t
\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\tClinical evidence shows clear
advantages using Verdye (ICG)<\/h2>\n \n
\n <\/th>\n ICG<\/th>\n RI<\/th>\n BD<\/th>\n <\/tr>\n \n \n 1st author<\/th>\n N (ICG)<\/th>\n Per-case
DR<\/th>\n Sensitivity<\/th>\n Avg.
# nodes<\/th>\n Per-case
DR<\/th>\n Sensitivity<\/th>\n Avg.
# nodes<\/th>\n Per-case
DR<\/th>\n Sensitivity<\/th>\n Avg.
# nodes<\/th>\n <\/tr>\n <\/thead>\n \n Niebling, 2016<\/td>\n 628<\/td>\n 99.4%<\/td>\n NA<\/td>\n 3.23<\/td>\n 94.0%<\/td>\n NA<\/td>\n NA<\/td>\n 85.0%<\/td>\n NA<\/td>\n NA<\/td>\n <\/tr>\n \n Zhang, 2016<\/td>\n 2594<\/td>\n 98.0%<\/td>\n 92.0%<\/td>\n NA<\/td>\n NA<\/td>\n NA<\/td>\n NA<\/td>\n NA<\/td>\n NA<\/td>\n NA<\/td>\n <\/tr>\n \n Sugie, 2017<\/td>\n 1736<\/td>\n 97.5%<\/td>\n 95.1%<\/td>\n NA<\/td>\n 96.7%<\/td>\n 90.9%<\/td>\n NA<\/td>\n NA<\/td>\n NA<\/td>\n NA<\/td>\n <\/tr>\n \n Mok, 2019<\/td>\n 4244<\/td>\n 97.9%<\/td>\n 99.4%<\/td>\n NA<\/td>\n 96.5%<\/td>\n 97.4%<\/td>\n NA<\/td>\n 86.8%<\/td>\n 81.6%<\/td>\n NA<\/td>\n <\/tr>\n \n Jeremiasse, 2020<\/td>\n 3544<\/td>\n 97.9%<\/td>\n NA<\/td>\n 2.37<\/td>\n 96.9%<\/td>\n NA<\/td>\n 1.69<\/td>\n 87.2%<\/td>\n NA<\/td>\n 1.80<\/td>\n <\/tr>\n \n Thongvitokomarn, 2020<\/td>\n 3377<\/td>\n 97.3%<\/td>\n NA<\/td>\n 2.35<\/td>\n 96.6%<\/td>\n NA<\/td>\n 1.72<\/td>\n 87.8%<\/td>\n NA<\/td>\n 1.92<\/td>\n <\/tr>\n \n Goonawardena, 2020<\/td>\n 2277<\/td>\n 96.5%<\/td>\n 93.7%<\/td>\n 2.09<\/td>\n 96.9%<\/td>\n 92.0%<\/td>\n 1.79<\/td>\n NA<\/td>\n NA<\/td>\n NA<\/td>\n <\/tr>\n \n Kedrzycki, 2021<\/td>\n 1292<\/td>\n 97.9%<\/td>\n NA<\/td>\n 1.98<\/td>\n 84.9%<\/td>\n NA<\/td>\n 1.55<\/td>\n 77.2%<\/td>\n NA<\/td>\n 1.79<\/td>\n <\/tr>\n \n Yin, 2021<\/td>\n <\/td>\n 97.6%<\/td>\n 98.3%<\/td>\n 2.05<\/td>\n 96.4%<\/td>\n 84.6%<\/td>\n 1.57<\/td>\n 89.2%<\/td>\n 84.5%<\/td>\n 1.93<\/td>\n <\/tr>\n \n Unweighted avg.<\/td>\n <\/td>\n 97.8%<\/td>\n 95.7%<\/td>\n 2.35<\/td>\n 94.9%<\/td>\n 91.2%<\/td>\n 1.66<\/td>\n 85.5%<\/td>\n 83.1%<\/td>\n 1.86<\/td>\n <\/tr>\n <\/tbody>\n<\/table>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t \n \n
\n \n Comparison<\/th>\n by > 5.0%<\/th>\n by 2.0 - 4.9%<\/th>\n Total<\/th>\n <\/tr>\n <\/thead>\n \n Superiority of ICG over BD<\/td>\n 11<\/td>\n 1<\/td>\n 12<\/td>\n <\/tr>\n \n Superiority of ICG over RI<\/td>\n 7<\/td>\n 3<\/td>\n 10<\/td>\n <\/tr>\n \n Superiority of RI over ICG<\/td>\n 0<\/td>\n 0<\/td>\n 0<\/td>\n <\/tr>\n \n Superiority of BD over ICG<\/td>\n 0<\/td>\n 0<\/td>\n 0<\/td>\n <\/tr>\n <\/tbody>\n<\/table>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\tKey findings from the meta-analysis concludes that10<\/sup>:<\/h2>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
For full details download our Breast SLN Brochure <\/a><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t