FDA Declines To Approve Aveo’s Drug For Kidney Cancer

Xconomy Boston — 

As expected, the hammer came down on Aveo Oncology (NASDAQ: AVEO) today as the FDA denied its application to approve tivozanib as a kidney cancer treatment. The complete response letter issued by the FDA closes the book on a chapter the Cambridge, MA-based biotech surely would like to forget.

The FDA, in its letter, called the results of the company’s 517-patient study of tivozanib “uninterpretable and inconclusive when making a risk-benefit assessment necessary for drug approval,” and recommended that Aveo run another trial before it can win approval of tivozanib as a kidney cancer treatment.

The decision comes as no surprise—an FDA advisory panel on May 2 voted overwhelmingly that Aveo must do just that, kick-starting a series of events that ultimately led the company to announce plans to lay off 62 percent of its workforce last week.

The panel was highly critical of the design of Aveo’s 517-patient study, as well as the fact that the fact that patients taking Bayer and Onyx’s sorafenib (Nexavar) lived longer than those taking tivozanib. Specifically, the median overall length of survival for patients on serafanib was 29.3 months, compared to 28.8 months for those taking tivozanib.

Aveo had strongly touted tivozanib’s tolerability, as well as data from its study showing that tivozanib kept patients’ tumors in check about three months longer than those taking sorafenib.

Since the panel, Aveo has abandoned plans to develop tivozanib as a kidney cancer drug, instead turning its attention towards two mid-stage clinical trials testing tivozanib in patients with colorectal cancer and triple-negative breast cancer. Aveo still has the backing of partner Astellas Pharma for both of those studies, from which Aveo expects data by the end of 2014.

Aveo will host a conference call on Tuesday to discuss the FDA’s letter and the May 2 panel.

Aveo shares closed at $2.34 apiece on Friday. They traded at more than $8 apiece before the panel.