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

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 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