Clinical Trial: BREZTRI REGULATORY POST MARKETING SURVEILLANCE IN KOREA

U.S., May 7 -- ClinicalTrials.gov registry received information related to the study (NCT07570394) titled 'BREZTRI REGULATORY POST MARKETING SURVEILLANCE IN KOREA' on April 30.

Brief Summary: As part of a post-approval commitment requested by the Ministry of Food and Drug Safety (MFDS), this open-label, single-arm, multicentre, observational Post-Marketing Surveillance (PMS) study aims to characterize the safety profile of Breztri in real-world clinical practice settings, either confirming known safety outcomes or identifying previously unsuspected adverse drug reactions. The study will also evaluate effectiveness of Breztri in real-world clinical practice settings, generating essential clinical evidence from a broader and more diverse Kor...