In DTC, grade 3-4 hypocalcemia occurred in 9% of LENVIMA-treated patients. Withhold and resume at reduced dose upon recovery based on severity. Monitor electrocardiograms in patients with congenital long QT syndrome, congestive heart failure, bradyarrhythmias, or those who are taking drugs known to prolong the QT interval, including Class Ia and III antiarrhythmics. Monitor and correct electrolyte abnormalities at baseline and periodically during treatment. In HCC, QTc interval increases of >60 ms occurred in 8% of LENVIMA-treated patients and QTc interval >500 ms occurred in 2%. Increases of >60 ms occurred in 11% of patients receiving LENVIMA + everolimus and QTc interval >500 ms occurred in 6%. The approval for this population is based on results from the pivotal Phase 3 KEYNOTE-775/Study 309 trial, in which KEYTRUDA plus LENVIMA demonstrated statistically significant improvements in overall survival (OS), reducing the risk of death by 32% (HR=0.68 p=0.0001), and progression-free survival (PFS), reducing the risk of disease progression or death by 40% (HR=0.60 p500 ms occurred in 2%. Food and Drug Administration (FDA) has approved the combination of KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai Inc. KENILWORTH & WOODCLIFF, N.J.-(BUSINESS WIRE). Study Results Demonstrated Statistically Significant Improvements in Overall Survival, Progression-Free Survival and Overall Response Rate, Helping to Address a Significant Unmet Need in Advanced Endometrial Carcinoma Immunotherapy and Tyrosine Kinase Inhibitor Combination Approved for the Treatment of Patients With Advanced Endometrial Carcinoma That is Not Microsatellite Instability-High or Mismatch Repair Deficient, Who Have Disease Progression Following Prior Systemic Therapy in Any Setting and Are Not Candidates for Curative Surgery or Radiation
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