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with locally advanced or metastatic urothelial cancer refractory to platinum-containing chemo and PD-1/PD-L1 inhibitor withdrawn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
“Between 2017 and 2023, the socioeconomic burden of HER2-positive breast cancer in ten major economies was nearly $590 billion, projected to increase to nearly $1,000 billion by 2032,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “At-home treatment may help alleviate the pressure
Richard Saynor, CEO of Sandoz, said: “The global burden of cancer continues to grow and the potential to address unmet patient needs has never been greater. This agreement offers us the chance to reach many more millions of patients, while helping to drive the long-term sustainability of healthcare systems.”
“Beyond the second-line monotherapy opportunity, we and our partners at Pfizer have removed plans for a Phase 3 first-line combination trial with atirmociclib, as well as the planned Phase 3 second-line combination trial with a CDK4/6 inhibitor, from our joint development plan,” continued Dr. Houston. “This decision was made following
“The interim PFS analysis results demonstrated that, compared to the current standard treatment, KN026 in combination with chemotherapy significantly improved PFS, reduced the risk of disease progression or death, and showed a trend toward OS benefit. Detailed data from this study will be presented at an upcoming international academic conference.”
