FDA Fast Tracks UV1 Vaccine Combo for Mesothelioma

The U.S. Food and Drug Administration granted fast-track designation to a new therapeutic cancer vaccine. The approval is for UV1 in combination with the immunotherapy drugs Opdivo (nivolumab) and Yervoy (ipilimumab) to manage malignant pleural mesothelioma that can’t be managed with surgery.  Therapeutic cancer vaccines, unlike preventive vaccines, treat existing cancers. Fast Track expedites the development of drug reviews for severe conditions. This way, the FDA can bring essential new drugs to patients earlier. With this designation, UV1 drug-maker Ultimovacs ASA will interact more frequently with the FDA during the vaccine’s development.  The phase II Nivolumab and Ipilimumab Plus/minus UV1 vaccination (NIPU) trial provided supporting data for the designation. Carlos de Sousa, chief executive officer at Ultimovacs, said of the trial in a press release: “The results from the first randomized UV1 phase 2 trial, NIPU…is a proof of concept for UV1.” “UV1 demonstrated a positive safety profile,” de Sousa noted. “It showed encouraging signs of improvement in overall survival in combination with the checkpoint inhibitors, ipilimumab, and nivolumab, in malignant mesothelioma, a hard-to-treat cancer indication with significant unmet need.” Improved Survival Led to Fast Track Designation During the NIPU trial, 118 pleural mesothelioma patients randomly received 1 of 2 treatments. The first group received Opdivo at 240 mg every 2 weeks plu...
Source: Asbestos and Mesothelioma News - Category: Environmental Health Authors: Tags: Clinical Trials/Research/Emerging Treatments Mesothelioma Source Type: news