U.S. FDA Grants Breakthrough Therapy Designation to Trodelvy ...
5 days ago · Trodelvy is being investigated for use in other TNBC and HR+/HER2- breast cancer populations, as well as a range of tumor types where Trop-2 is highly expressed, including small cell lung cancer and first-line metastatic non-small cell lung cancer where Trodelvy has shown clinical activity through the TROPiCS-03 proof-of-concept study and the ...
Trodelvy Indication for Advanced Urothelial Cancer to Be …
Oct 22, 2024 · In 2021, the US Food and Drug Administration (FDA) granted accelerated approval for Trodelvy to treat patients with locally advanced or metastatic urothelial cancer who were previously treated...
Gilead Withdraws Bladder Cancer Drug in US After Failed Trial - U.S. News
Oct 18, 2024 · (Reuters) -Gilead Sciences said on Friday it was voluntarily withdrawing its drug, Trodelvy, for patients with a type of bladder cancer after it failed to meet the main goal in a confirmatory...
FDA Grants Breakthrough Therapy Status To Gilead's Trodelvy For ...
5 days ago · (RTTNews) - Gilead Sciences, Inc. (GILD) Tuesday said that the U.S. Food and Drug Administration or FDA has granted Breakthrough Therapy Designation to Trodelvy for the treatment of adults with ...
FDA grants Breakthrough status to Trodelvy for SCLC
3 days ago · As recently presented at the IASLC 2024 World Conference on Lung Cancer, Trodelvy demonstrated promising antitumor activity in both platinum-resistant (PR) and platinum-sensitive (PS) disease and the safety profile was consistent with previous Trodelvy studies. These data support further investigation of Trodelvy in ES-SCLC and Gilead plans to ...
Trodelvy US Indication for Metastatic Urothelial Cancer to Be
Oct 18, 2024 · In a phase 3 trial, more deaths due to adverse events were reported in the Trodelvy arm compared with the chemotherapy arm. Gilead has made the decision to withdraw the accelerated approval of...
FDA Breakthrough status for Trodelvy in ES-SCLC
4 days ago · The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed on or after platinum-based chemotherapy, said Gilead Sciences. ... All the news that moves the ...
Gilead withdraws Trodelvy in bladder cancer - Yahoo Finance
Oct 18, 2024 · Gilead will no longer sell its combination drug Trodelvy to treat bladder cancer, announcing Friday it had agreed with the Food and Drug Administration to withdraw it following negative trial...
GILD's Trodelvy Gets Second Breakthrough Therapy Tag for Lung …
4 days ago · Gilead’s Trodelvy is currently approved for second-line or later metastatic triple-negative breast cancer (TNBC) patients in more than 50 countries and for certain patients with pre-treated HR+ ...
FDA Approves New Therapy for Triple Negative Breast Cancer That …
Apr 22, 2020 · FDA granted accelerated approval to Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult patients with triple-negative breast cancer that has spread. Patients must have received...
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