FDA recommends new trial of Astellas, Aveo's tivozanib for renal cancer in complete response letter

Aveo Oncology announced Monday the receipt of a complete response letter from the FDA recommending a new clinical trial of tivozanib for the treatment of patients with advanced renal cell carcinoma (RCC). In its letter, the agency said that "the inconsistent progression-free survival and overall survival results and imbalance in post-study treatments make the TIVO-1 results uninterpretable and inconclusive when making a risk-benefit assessment necessary for drug approval."

Last month, an advisory panel voted 13 to 1 that tivozanib did not demonstrate a favourable benefit-to-risk evaluation for the treatment of advanced RCC in an adequate and well-controlled trial. In documents released ahead of the advisory panel vote, agency staff also suggested that an additional trial may be necessary, as tivozanib was associated with better overall survival than Bayer and Onyx Pharmaceuticals' Nexavar (sorafenib) but worse progression-free survival.

Earlier this month, Aveo announced that it was reducing its workforce by 62 percent and would no longer pursue approval of tivozanib for the treatment of RCC, instead choosing to focus on development of the drug in colorectal and breast cancer. In May, Astellas, which is co-developing tivozanib with Aveo, revealed that it would not seek approval for the therapy in Europe for the treatment of RCC or fund future studies of the drug for this indication.

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