Accelerated approval for Trodelvy® (sacituzumab govitecan-hziy) for patients with locally advanced or metastatic urothelial cancer refractory to platinum-containing chemo and PD-1/PD-L1 inhibitor withdrawn
“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. Continued approval for this indication was contingent on verification and description of clinical benefit in the confirmatory TROPiCS-04 study. As previously announced, the TROPiCS-04 study did not meet the primary endpoint of overall survival (OS) in the intention-to-treat (ITT) population. These data will be presented at an upcoming medical meeting.”
Share:
More News
“The initial efficacy data from the Part C studies are consistent with the encouraging efficacy signals we previously reported for Parts A and B of THIO-101, including an 88% disease control rate in third-line NSCLC patients. This measure of efficacy is close to triple the reported outcome for standard-of-care chemotherapy
“Patients with non-muscle invasive bladder cancer continue to face a significant risk of disease recurrence despite available treatment options,” said Mark Schoenberg, M.D., Chief Medical Officer of UroGen. “UGN-501 is an investigational next-generation oncolytic virus designed to selectively destroy tumor cells while generating an anti-tumor immune response. FDA clearance of
“Whitehawk has established strong expertise in ADC technology and oncology drug development,” said Dr. Yuelei Shen, President and CEO of Biocytogen. “This collaboration further expands the application of Biocytogen’s fully human bispecific antibodies in ADC development. We look forward to supporting the efficient advancement of multiple programs by contributing high-quality
Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: “The AZUR-1 results support the potential for dostarlimab to transform treatment for dMMR/MSI-H locally advanced rectal cancer. For many patients today, rectal cancer treatment comes with the tolerability burden and lasting impacts from chemotherapy, radiation and surgery. These data