Buffeted by setbacks over the past two months, Aveo Pharmaceuticals Inc. said Tuesday it will lay off 140 employees and halt efforts to win approval of its kidney cancer drug.
The move, which slashes Aveo’s workforce by 62 percent, is part of a restructuring by the Cambridge biotechnology company that will formally be unveiled Wednesday morning in a conference call with industry analysts. Under the plan, Aveo intends to refocus its experimental kidney drug, called tivozanib, on treating colorectal and breast cancers.
Aveo vice president Rob Kloppenburg said company executives weren’t available to discuss the job cuts and strategy change Tuesday. But in a statement, chief medical officer William J. Slichenmyer conceded the Food and Drug Administration likely would reject Aveo’s application for approval of tivozanib to treat renal cell carcinoma, a kidney cancer that kills tens of thousands of people every year.
FDA officials are scheduled to rule by July 28 whether to approve Aveo’s capsule for sale in the United States, but a favorable decision is not expected. On May 1, an FDA advisory committee voted 13-1 to recommend the agency reject tivozanib as a treatment for renal cell carcinoma, suggesting it was not clearly superior to existing treatments. There are at least five other approved drugs to treat that form of kidney cancer. Though none cure the disease, all extend — and improve the quality of — patients’ lives.
In a late-stage clinical trial of 517 patients, comparing Aveo’s capsule to the drug Nexavar, tivozanib met its goal of slowing progression of the disease. But patients taking Nexavar showed better overall survival rates. Given those results, FDA staffers in April suggested another clinical trial may be needed to weigh the risks and benefits of the Cambridge company’s treatment.
Aveo’s ability to finance such a study was dealt a blow May 23 when its Japanese partner, Astellas Pharma Inc., pulled out of an agreement to seek approval of tivozanib in Europe. Aveo and Astellas continue to test the experimental drug as a treatment for other cancers.
In its statement Tuesday, the Cambridge company said its restructuring was meant to extend its cash for at least two years until the company had results from other clinical trials now underway.