Aveo backs off on tivozanib approval after FDA calls for more conclusive data
pharmafile | November 6, 2019 | News story | Research and Development, Sales and Marketing | Aveo Oncology, FDA, pharma
Aveo Oncology has hit another hurdle in its quest for approval of its vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI) tivozanib for the treatment of highly refractory metastatic renal cell carcinoma (RCC), after the FDA advised the company not to pursue marketing authorisation off the back of its latest data for the drug.
The latest study compared to tivozanib to sorafenib in a bid to address the FDA’s earlier concerns over inconsistencies in progression-free survival (PFS) and overall survival (OS) benefit results, which the agency said complicated any benefit/risks assessment it would need to make in order to issue an approval.
Aveo recently announced that this latest study had met its primary and secondary endpoints by demonstrating “significant improvement” in PFS and OS. However, upon reviewing this new data holistically with the old, the FDA said that these new interim data do not assuage its concerns, noting the findings may show worse results by the trial’s final analysis.
As a result, Aveo were advised against submitting a new drug application at this time. Aveo also informed the US regulator that, “in view of the changing first-line treatment landscape as well as the FDA’s continued concerns,” it would be narrowing its proposed indication to relapsed/refractory RCC, and now plans to submit an application following the final analysis of the trial in the first half of next year. Both parties agreed that should these final analysis results reveal an OS hazard ratio of above 1.00, Aveo will scrap its application efforts.
“During the meeting with the FDA, we believe that we established an appropriate path forward toward filing an NDA for tivozanib in the near term and a final analysis plan for OS,” said Michael Bailey, President and CEO at Aveo. “The continued separation of the PFS curves and the positive trend in OS HR observed from the first to the second interim analysis, together with tenfold more patients remaining progression free and on tivozanib vs sorafenib therapy, make us believe that the final OS results will not worsen.”
Matt Fellows
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