AVEO stock falling fast amid EMA warning

Investors in USA-based AVEO Oncology (Nasdaq: AVEO) appear to be fearing the worst after the future of the company’s lead candidate was thrown into doubt.

Fotivda (tivozanib) was approved by the European Medicines Agency (EMA) 2017 as a first-line treatment in advanced or metastatic renal cell carcinoma (RCC) and for patients who are vascular endothelial growth factor receptor and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for RCC.

"The CHMP provided that regulatory action should be considered if interim OS analysis confirms a negative trend"The approval, which was granted to AVEO’s licensee, EUSA Pharma, was based on results from the TIVO-1 study, which showed that patients given Fotivda had superior progression-free survival (PFS) to those who received Bayer’s (BAYN: DE) Nexavar (sorafenib).