Pfizer Inc ((PFE)) announced an update on their ongoing clinical study.
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Pfizer Inc. has initiated a study titled ‘Post-Approval Safety Monitoring Program to Assess the Safety and Efficacy Profile of TUKYSA in Usual Practice’ to evaluate the clinical usefulness of TUKYSA in Korea. The study aims to gather, review, and verify safety and efficacy data for HER2-positive locally advanced unresectable and metastatic breast cancer treatments in real-world settings, as part of Korea’s re-examination system for pharmaceuticals.
The intervention under review is TUKYSA, a medication intended to treat HER2-positive breast cancer. Its purpose is to confirm its safety and effectiveness in everyday medical practice in Korea.
This observational study follows a cohort model with a prospective time perspective. The primary goal is to collect real-world data on TUKYSA’s performance, with no specific allocation or masking involved.
The study was first submitted on March 6, 2025, and the latest update was on August 14, 2025. The study is not yet recruiting, indicating that the primary completion and estimated completion dates are still pending.
This update could influence Pfizer’s stock performance positively, as successful post-approval studies can enhance investor confidence and market position. Competitors in the HER2-positive breast cancer treatment space will be closely monitoring these developments.
The study is ongoing, with further details available on the ClinicalTrials portal.