Aveo's Tivozanib Under CHMP Spotlight If Negative OS Trend Continues In TIVO-3
An August 2019 analysis of overall survival in the TIVO-3 study of Aveo’s tivozanib in advanced renal cell carcinoma is now an interim rather than a final analysis, but EU regulators may take action if a negative overall survival trend is found to be continuing.
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After repeatedly advising against tivozanib NDA submission on the basis of interim overall survival data that suggested a negative trend, agency ultimately concluded the final analysis did not suggest a detrimental effect in third-line renal cell carcinoma even though median overall survival was shorter than for the comparator agent, Bayer’s Nexavar.
Keeping Track: Oncology Submissions From Blueprint, Y-mAbs, BMS/bluebird; Approvals For BMS’ Reblozyl, LFB’s SevenFact
The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker.
In a move that will generate further useful cash for AVEO, Kyowa Kirin has reacquired global rights to non-oncology uses of tivozanib.