Negative FDA news for AVEO's tivozanib and Dynavax' hep B vaccine

US biotech firm AVEO Oncology (Nasdaq: AVEO) says that it has received a complete response letter from the US Food and Drug Administration saying that the FDA will not approve in its present form the New Drug Application for the company’s investigational agent tivozanib for the treatment of patients with advanced renal cell carcinoma (RCC).

In the letter, the FDA stated 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, and recommended that AVEO conduct an additional clinical study to support approval of tivozanib for the treatment of advanced RCC. The FDA also stated that the proposed dissolution acceptance criterion was not supported by the provided dissolution data, and would need to be updated and resubmitted.

The news follows last week’s announcement of AVEO’s strategic restructuring that will refocus the company’s efforts and resources on the ongoing clinical development of tivozanib in colorectal and breast cancer, as well as advancing key pipeline and preclinical assets, given doubts about the drug’s future in RCC (The Pharma Letter June 5). The drug is partnered with Japanese drug major Astellas Pharma (TYO: 4503), which last month stated that it will not to proceed with a European filing for tivozanib or financially support future clinical trials in the RCC indication.