Tivozanib’s Efficacy Behind Checkpoint Inhibitors In Renal Cell Carcinoma Reassured US FDA
Approximately 25% of patients in the TIVO-3 trial had prior treatment with checkpoint inhibitors, but progression-free survival in this subgroup was similar to the overall population, giving the FDA confidence about tivozanib's role in contemporary treatment regimens, Drug Review Profile finds.
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Despite lack of enthusiasm with immunobridging study data, the panel endorsed emergency use in certain at-risk populations, in part because it would be hard to turn down the Moderna booster when an identical EUA had been issued for Pfizer/BioNTech's mRNA vaccine.
Immune responses to a single booster dose of mRNA-1273 would be considered successfully bridged to the two-dose primary series if each of two immunobridging criteria were met, but the mRNA vaccine missed the prespecified success criteria for seroresponse rate, the FDA said.
Takeda’s Maribavir Post-Transplant CMV Indication Should Not Be Limited By Resistance, US Panel Says
Advisory committee unanimously endorses novel antiviral for treatment of post-transplant patients with refractory/resistant cytomegalovirus infection, and in the process rejects US FDA’s proposal to distinguish target population based upon genetic resistance.