FDA approves LENVIMA-KEYTRUDA combination therapy for specific types of endometrial cancer
Last Update: 2020-06-17
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The Orbis project provides a framework for its international partners to submit and review cancer drugs simultaneouslyUnder the program, the FDA, the Australian Drug Administration (TGA) and Health Canada jointly reviewed applications for two cancer drugs, allowing simultaneous decisions in all three countriesthe approval is based on data from study 111/KEYNON-146, a phase II, multi-group, open-label, open-label, single-group trial that included 108 patients with metastatic endometrial cancer who had progression after at least one systemic treatment in any caseIn 94 patients without MSI-H or dMMR, LENVIMA-KEYTRUDA combined therapy showed ANR of 38.3% (95% CI, 29-49), a full response rate of 10.6% (n-10) and a partial response rate of 27.7% (n-26)In patients who were identified as having a reaction through an independent review (n-36), the median DOR (ranging from 1.2 to 33.1 plus months) was not reached at the data deadline; The most common adverse reactions to LENVIMA-KEYTRUDA combination therapy were fatigue, musculoskeletal pain, high blood pressure, diarrhea, loss of appetite, hypothyroidism, nausea, stomatitis, vomiting, weight loss, abdominal pain, headache, constipation, urinary tract infections, vocal disorders, bleeding events, hypomatoemia, hand and foot syndrome, dyspnea, coughs and rashesNote: Cut in the original text
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