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NC: What are the most recent developments in your genotoxicity studies and which are proving most successful? IS: Our genotoxicity testing includes the core battery of the tests requested by EMEA/ICH including mutagenicity in vitro, chromosomal aberration test in vitro and micronucleus test in vivo.
A global, randomized Phase 3 confirmatory clinicaltrial TROPiCS-04 (NCT04527991) is underway and is also intended to support global registrations. TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. More information on TROPiCS-04 is available at [link]. About Trodelvy.
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