Aveo Pharmaceuticals Inc. said Monday that its renal cancer drug "tivozanib" was not approved by the U.S. Food and Drug Administration for insufficient clinical trial data.
Aveo Oncology received a Complete Response letter from FDA saying the renal cancer drug tivozanib will not be approved for marketing based on its current clinical trial. FDA said that the drug trial had inconsistent progression-free, survival rates and post-treatment therapies.
FDA further recommended that the company should conduct new clinical trials on the drug to draw meaningful conclusions. Earlier in May, an FDA advisory panel had strongly opposed the approval of tivozanib as the benefits of the drug did not outdo the risks.
Aveo developed the drug along with Astellas Pharma, a Japanese pharmaceutical company. Astellas did not file for the approval of the drug in Europe and also withdrew its funding for further clinical trials on the renal cancer drug. Tivozanib is the first most advanced experimental drug for Aveo.
During an experimental trial conducted on 517 patients, the drug tivozanib reportedly provided delivered progression-free survival of 11.9 months while the drug sorafenib provided only 9.1 months of survival. However, after a two year follow up, the advisory panel found that while tivozanib delivered only 28.8 months of survival, sorafenib, FDA approved renal cancer drug, showed a 29.3 month survival.
The drug risks concerned the doctors about the outcome. "I cannot picture how I would be able to talk with a patient about treating him or her with a drug, tivozanib, that would allow that person to live without progression longer but to possibly die faster than if I treated that person with another available renal cell carcinoma drug," said committee Chair Mikkael Sekeres, MD, of the Cleveland Clinic's Taussig Cancer Institute, according to MedPage Today.
