Aveo and Astellas have received a blow in the US after an advisory committee to the FDA refused to back the approval of their cancer drug tivozanib in a near-unanimous vote.
The Oncologic Drugs Advisory Committee (ODAC) agreed by 13 votes to 1 that tivozanib did not demonstrate a favourable benefit-to-risk evaluation for the treatment of advanced renal cell carcinoma (RCC).
The Committee’s decision was based on several studies, including the pivotal phase III TIVO-1 trial, which compared tivozanib to Bayer/Onyx Pharmaceuticals’ already available Nexavar (sorafenib).
During this trial, Nexavar actually demonstrated slightly superior overall survival compared to tivozanib, but Aveo and Astellas argued that this was because the trial allowed for patients to switch from Nexavar to tivozanib once their disease had progressed.
This could potentially have skewed the results, and the trial design came under criticism from the FDA Committee.
The FDA isn’t bound by the ODAC’s decision, although the strength of the vote doesn’t bode well for Aveo and Astellas.
The full review of the new drug application for tivozanib is expected to be completed by July 28, 2013.
Tuan Ha-Ngoc, president and CEO of AVEO, said: “While we are disappointed with the outcome of the ODAC vote, we remain confident in the efficacy, safety and tolerability of tivozanib in RCC patients.
“We are committed to the RCC patient community and will work closely with the FDA to address the issues discussed by the panel today as the agency continues its ongoing review of the new drug application for tivozanib.”
The drug was originally developed by Aveo, which then entered an agreement with Astellas to further develop and commercialise the drug for several cancers.
Subject to regulatory approval, AVEO will lead commercialisation of tivozanib in North America and Astellas will lead commercialisation of tivozanib in the EU.