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.
週五，吉利德科學公司(NASDAQ:GILD)宣佈計劃自願撤回Trodelvy (sacituzumab govitecan-hziy; SG)在美國的加速批准，該藥用於先前接受含鉑的化療和程序性死亡受體-1 (PD-1)或程序性死亡配體-1 (PD-L1)抑制劑治療的局部晚期或轉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.
此外閱讀：吉利德科學公司召回其一批COVID-19治療藥物，因玻璃顆粒存在。
The decision was made in consultation with the FDA and does not affect the other approved Trodelvy indications within or outside the U.S.
此決定是在與FDA協商後作出的，並不影響Trodelvy在美國境內或境外獲得的其他批准適應症。
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基於來自全球第2階段單臂TROPHY-U-01研究的腫瘤反應率和反應持續時間數據，於2021年獲得轉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.
對於此適應症的繼續批准取決於在確認性TROPiCS-04研究中對臨床益處的驗證和描述。
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，吉利德科學宣佈了來自局部晚期或轉移性尿路上皮癌的確認性第3期TROPiCS-04研究的最終結果。
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研究評估了先前接受含鉑化療和抗PD-(L)1治療的mUC患者中的Trodelvy (sacituzumab govitecan-hziy; SG)與單藥化療(醫生選擇的治療，TPC)的比較。
The study did not meet the primary endpoint of overall survival (OS) in the intention-to-treat (ITT) population.
研究並未在意圖治療全人群中達到總生存期(OS)這一主要終點。
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是首個獲批的Trop-2靶向抗體-藥物複合物（ADC），已證明在2L+轉移性TNBC和預處理的HR+/HER2—轉移性乳腺癌中具有明顯的生存優勢。
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.
超過20項正在進行的臨床試驗正在評估Trodelvy作爲單藥或與其他藥物聯合治療各種固體腫瘤，包括肺癌和婦科癌。
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正在進行第3期EVOKE-03試驗，與默沙東（Merck & Co Inc, NYSE:MRK）的Keytruda（Pembrolizumab）聯合治療PD-L1高表達的轉移性非小細胞肺癌。
Started in February 2023, the trial is expected to conclude in January 2027.
該試驗始於2023年2月，預計將於2027年1月結束。
Price Action: GILD stock is down 0.67% at $86.78 at last check Friday.
價格走勢：吉利德科學的股價在上週五最後一次檢查時下跌0.67%，報86.78美元。
- Spirit AeroSystems Plans Employee Furloughs Amid Ongoing Boeing Strike, Faces Layoff Risk.
- 在波音罷工持續期間，spirit aerosystems計劃員工休假，面臨裁員風險。
譯文內容由第三人軟體翻譯。
