The most common adverse reactions (all grades ≥20%) for patients receiving KEYTRUDA were peripheral neuropathy (47%), nausea (46%), fatigue (40%), diarrhea (36%), vomiting (34%), decreased appetite (29%), abdominal pain (26%), palmar-plantar erythrodysesthesia syndrome (25%), constipation (22%) and weight loss (20%). Dosage interruptions of KEYTRUDA due to adverse reactions occurred in 65% of patients adverse reactions or laboratory abnormalities leading to interruption of KEYTRUDA (≥2%) were neutropenia (21%), thrombocytopenia (13%), diarrhea (5.5%), fatigue (4.8%), infection (4.8%), anemia (4.5%), increased aspartate aminotransferase (AST) (4.3%), increased alanine aminotransferase (ALT) (3.8%), increased blood bilirubin (3.3%), white blood cell count decreased (2.2%), nausea (2%), palmar-plantar erythrodysesthesia syndrome and vomiting (2% each). Adverse reaction resulting in permanent discontinuation of KEYTRUDA in ≥1% were infections (1.8%) and diarrhea (1.0%). Permanent discontinuation of KEYTRUDA due to adverse reactions occurred in 15% of patients. Fatal adverse reactions occurred in 8% of patients who received KEYTRUDA including infection (2.3%) and thromboembolism (1.3%). The approval is based on data from the Phase 3 KEYNOTE-859 trial, in which KEYTRUDA plus chemotherapy reduced the risk of death by 22% (HR=0.78 p2% of patients included pneumonia (4.1%), diarrhea (3.9%), hemorrhage (3.9%) and vomiting (2.4%). Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. ![]() ![]() Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Approval based on results from the Phase 3 KEYNOTE-859 trial, which demonstrated significant improvement in overall survival in these patients versus chemotherapy aloneĪpproval marks seventh gastrointestinal cancer indication for KEYTRUDA-based regimens and 38 th indication for KEYTRUDA in the US
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