FDA approves lenVIMA and KEYTRUDA for treatment of patients with advanced endometrial cancer

today, Atva and Mershadon announced that the U.SFood andDrug(http://Administration (
FDA(http://) has approved a combination of LENVIMA (Chinese) and KEYTRUDA (Chinese) for the treatment of non-satellite high-risk instability (MSI-H) or misalignment repair defects (dMRM), progress on the disease after prior systemic therapy and is not suitable for advanced endometrial cancer after prior systemic therapyThe Orbis project provides a framework for both its international partners to submit and review cancer drugsUnder the program, the FDA, the Australian Drug Administration (TGA) and Health Canada jointly reviewed applications for two cancer drugs, allowing decisions to be made simultaneously in all three countriesThe approval was based on data from the study 111/KEYNON-146, a phase II, multi-cohort, multi-center, open label, single-grouptrial(http://that included 108 patients with metastatic endometrial cancer who underwent at least one full body treatment in any caseIn 94 patients without MSI-H or dMMR, the LENVIMA-KEYTRUDA combination therapy showed orR with a total response rate of 10.6% (n-10) and a partial response rate of 27.7% (n-26)In patients identified as having a reaction through an independent review (n-36), the median DOR was not reached at the data deadline (range from 1.2 to 33.1 plus months);The most common adverse reactions to lenVIMA-KEYTRUDA combination therapy were fatigue, musculoskeletal pain, hypertension, diarrhea, loss of appetite, hypothyroidism, nausea, stomatitis, vomiting, weight loss, abdominal pain, headache, constipation, urinary tract infections, vocal disorders, bleeding events, hypomagnesis, hand and foot syndrome, dysphecin, cough and rash