The Pharma Data

MARCH 25, 2021

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.

Genotoxicity 52

Genotoxicity Genotype Containment Protein 52

The Pharma Data

APRIL 14, 2021

Continued approval is contingent upon verification and description of clinical benefit in a confirmatory trial. A global, randomized Phase 3 confirmatory clinical trial TROPiCS-04 (NCT04527991) is underway and is also intended to support global registrations. More information on TROPiCS-04 is available at [link]. About Trodelvy.

Genotype 52

Genotype Containment FDA Approval Genotoxicity 52

The Pharma Data

APRIL 7, 2021

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

HR Genotype FDA Approval Genotoxicity 52