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Based on a recommendation from the FDA, Aveo Oncology has decided not to submit a new drug application for tivozanib. The FDA has advised it was not satisfied with the preliminary overall survival data from the phase III TIVO-3 trial of patients with highly refractory, advanced or metastatic renal cell carcinoma.

Treatment with the immune checkpoint inhibitor nivolumab demonstrated dose-limiting toxicities when combined with the tyrosine kinase inhibitors sunitinib or pazopanib to treat advanced or metastatic renal cell carcinoma, according to the results of a phase I parallel cohort dose escalation trial. However, both combinations showed encouraging preliminary antitumor activity.

Patients with metastatic renal and urothelial bladder cancer who receive antibiotics concomitantly with immune checkpoint inhibitors have shorter progression-free survival and overall survival rates than patients who do not, according to a poster presented at the European Congress on Immunotherapies in Cancer™ conference, hosted by Physicians’ Education Resource®, LLC, September 21 and 22, 2018, in Barcelona, Spain.

Nivolumab in combination with low-dose ipilimumab has been recommended by the European Medicines Agency’s Committee for Medicinal Products for Human Use as treatment for patients with intermediate- and poor-risk advanced renal cell carcinoma in the frontline setting, according to Bristol-Meyers Squibb, the developer of both immunotherapy agents.