After Failed Confirmatory Trial, Gilead Withdraws US Accelerated Approval Of Trodelvy As Bladder Cancer Treatment
After Failed Confirmatory Trial, Gilead Withdraws US Accelerated Approval Of Trodelvy As Bladder Cancer Treatment
Trodelvy was granted accelerated approval for metastatic urothelial cancer in 2021 based on tumor response rate and duration of response data from the global Phase 2, single-arm TROPHY-U-01 study.On Friday, Gilead Sciences, Inc. (NASDAQ:GILD) announced plans to voluntarily withdraw the U.S. accelerated approval for Trodelvy (sacituzumab govitecan-hziy; SG) for adult patients with locally advanced or metastatic urothelial cancer who have previously received platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.
周五，吉利德科学公司(NASDAQ:GILD)宣布计划自愿撤回Trodelvy (sacituzumab govitecan-hziy; SG)在美国的加速批准，该药用于先前接受含铂的化疗和程序性死亡受体-1 (PD-1)或程序性死亡配体-1 (PD-L1)抑制剂治疗的局部晚期或转移性尿路上皮癌成人患者。
Also Read: Gilead Sciences Recalls One Lot Of Its COVID-19 Treatment Due To Presence Of Glass Particles.
此外阅读：吉利德科学公司召回其一批COVID-19治疗药物，因玻璃颗粒存在。
The decision was made in consultation with the FDA and does not affect the other approved Trodelvy indications within or outside the U.S.
此决定是在与FDA协商后作出的，并不影响Trodelvy在美国境内或境外获得的其他批准适应症。
Trodelvy was granted accelerated approval for metastatic urothelial cancer in 2021 based on tumor response rate and duration of response data from the global Phase 2, single-arm TROPHY-U-01 study.
Trodelvy基于来自全球第2阶段单臂TROPHY-U-01研究的肿瘤反应率和反应持续时间数据，于2021年获得转移性尿路上皮癌的加速批准。
Continued approval for this indication was contingent on verification and description of clinical benefit in the confirmatory TROPiCS-04 study.
对于此适应症的继续批准取决于在确认性TROPiCS-04研究中对临床益处的验证和描述。
In May, Gilead Sciences announced topline results from the confirmatory Phase 3 TROPiCS-04 study in locally advanced or metastatic urothelial cancer (mUC).
今年5月，吉利德科学宣布了来自局部晚期或转移性尿路上皮癌的确认性第3期TROPiCS-04研究的最终结果。
The TROPiCS-04 study evaluated Trodelvy (sacituzumab govitecan-hziy; SG) vs. single-agent chemotherapy (treatment of physicians' choice, TPC) in patients with mUC who have previously received platinum-containing chemotherapy and anti-PD-(L)1 therapy.
TROPiCS-04研究评估了先前接受含铂化疗和抗PD-(L)1治疗的mUC患者中的Trodelvy (sacituzumab govitecan-hziy; SG)与单药化疗(医生选择的治疗，TPC)的比较。
The study did not meet the primary endpoint of overall survival (OS) in the intention-to-treat (ITT) population.
研究并未在意图治疗全人群中达到总生存期(OS)这一主要终点。
Trodelvy is the first approved Trop-2-directed antibody-drug conjugate (ADC), which has demonstrated meaningful survival advantages in both 2L+ metastatic TNBC and pre-treated HR+/HER2—metastatic breast cancer.
Trodelvy是首个获批的Trop-2靶向抗体-药物复合物（ADC），已证明在2L+转移性TNBC和预处理的HR+/HER2—转移性乳腺癌中具有明显的生存优势。
More than 20 ongoing clinical trials are evaluating Trodelvy as a monotherapy and in combination with other agents across a range of solid tumors, including lung and gynecological cancers.
超过20项正在进行的临床试验正在评估Trodelvy作为单药或与其他药物联合治疗各种固体肿瘤，包括肺癌和妇科癌。
Trodelvy's is being evaluated in a Phase 3 EVOKE-03 trial in combination with Merck & Co Inc's (NYSE:MRK) Keytruda (Pembrolizumab) in PD-L1-high Metastatic Non-small Cell Lung Cancer.
Trodelvy正在进行第3期EVOKE-03试验，与默沙东（Merck & Co Inc, NYSE:MRK）的Keytruda（Pembrolizumab）联合治疗PD-L1高表达的转移性非小细胞肺癌。
Started in February 2023, the trial is expected to conclude in January 2027.
该试验始于2023年2月，预计将于2027年1月结束。
Price Action: GILD stock is down 0.67% at $86.78 at last check Friday.
价格走势：吉利德科学的股价在上周五最后一次检查时下跌0.67%，报86.78美元。
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