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Treatment of Metastatic Triple-Negative Breast Cancer

The Pharma Data

Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. SG contains a genotoxic component and can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. About the ASCENT Study. Embryo-Fetal Toxicity.

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Trodelvy® for the Treatment of Metastatic Urothelial Cancer

The Pharma Data

Accelerated Approval Granted for Locally Advanced or Metastatic Urothelial Cancer Following a Platinum-Containing Chemotherapy and a PD-1/PD-L1 Inhibitor –. – New Indication Marks Second FDA Approval for Trodelvy in 2021 –. Continued approval is contingent upon verification and description of clinical benefit in a confirmatory trial.

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Trodelvy®, the First Treatment for Metastatic Triple-Negative Breast Cancer Shown to Improve Progression-Free Survival and Overall Survival

The Pharma Data

The Phase 3 ASCENT study, an open-label, active-controlled, randomized confirmatory trial, enrolled more than 500 patients with relapsed/refractory metastatic triple-negative breast cancer (TNBC) who had received two or more prior systemic therapies (including a taxane), at least one of them for metastatic disease. About the ASCENT Study.

HR 52