Aveo’s Tivozanib Troubles Reflect Perils Of Ex-U.S. Studies
Pivotal study for the renal cell carcinoma drug was conducted largely in Central and Eastern Europe, where limited access to second-line targeted therapies does not reflect the U.S. practice. In recommending against approval, FDA’s Oncologic Drugs Advisory Committee questioned the study results’ applicability to the U.S.
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Keeping Track: US FDA Acts On 5 Novel Drugs: Approval For Fotivda, Pepaxto, Azstarys; CRLs For Defencath and Oral Paclitaxel
The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker
The approval marks the first commercial launch for Aveo in the US, but tivozanib has shown modest efficacy in cancer and the approval is relegated to later lines.
In the Phase III TIVO-3 study, tivozanib is associated with a trend toward adverse survival and trial has missing data issues.