AVEO Pharmaceuticals (NASDAQ:AVEO) slumps 44% premarket on robust volume in reaction to its update on Fotivda (tivozanib) in patients with highly treatment-resistant renal cell carcinoma (RCC).
Citing the totality of the data, the FDA recommended that it not submit a marketing application at this time, remaining “concerned” with the overall survival (OS) data in the Phase 3 TIVO-3 study, specifically, that it may be worse than the comparator drug, Bayer’s Nexavar (sorafenib). The second interim OS analysis, conducted in August, showed a hazard ratio of 0.99 at year 2, meaning that treatment with tivozanib reduced the risk of death by only 1% compared to sorafenib.
The agency informed the company that if it decides to file an NDA, it should include an updated statistical analysis plan with updated OS data, adding that an advisory committee review will be necessary.
Undeterred, the company plans to narrow the proposed indication to to relapsed/refractory RCC and file an NDA in Q1 2020. If the final OS analysis, expected to be reported in June 2020, shows a hazard ratio above 1.00, then it will withdraw the application.
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