One manufacturer has decided not to file for FDA approval of its renal cell carcinoma (RCC) treatment, while another manufacturer’s combination of RCC drugs has won European approval.
Aveo Oncology, based in Cambridge, MA, decided against filing a new drug application for tivozanib (brand name Fotivda) in the United States. The FDA had informed Aveo that it was unsatisfied with the drug’s overall survival data, and that the data failed to improve upon initial concerns the FDA had when it rejected the drug in 2013.
In that year, the FDA questioned the drug’s benefits because data showed that tivozanib failed to beat the overall survival rate of Bayer’s drug, Nexavar, FierceBiotech reported. An August 2018 analysis of required data will no longer be Aveo’s final analysis but rather an interim analysis as the company continues toward FDA approval. Fotivda is approved for first-line treatment of advanced RCC in Europe.
Meanwhile, an RCC treatment that consists of a drug combination was approved for European patients. Bristol-Myers Squibb (Princeton, NJ) announced that the European Commission had approved the combination of its trademarked drugs Opdivo (nivolumab) 3 mg/kg plus Yervoy (ipilimumab) 1 mg/kg (“low-dose”).
The combination therapy is a first-line therapy to treat patients with intermediate- and poor-risk advanced RCC. The European approval hinged on results from the CheckMate-214 trial, a phase 3, randomized, open-label study evaluating the combination of Opdivo plus Yervoy versus sunitinib in patients with previously untreated advanced renal cell carcinoma. The FDA has already approved the combination for certain patients whose cancer has metastasized.