FDA Fast-Tracks Mesothelioma Vaccine Development

The U.S. Food and Drug Administration has granted Fast-Track Designation this week to ONCOS-102, an immunotherapy vaccine that targets malignant mesothelioma and other hard-to-treat tumors. This designation is expected to expedite the regulatory approval process. The vaccine’s developer, Targovax, a small biotech company that focuses on oncolytic viruses, sees this as an early endorsement from the FDA. “Yes, this opens the door for us,” Dr. Magnus Jaderberg, chief medical officer of Targovax, told The Mesothelioma Center at Asbestos.com. “It validates what the FDA believes is a potentially promising drug for this disease. That’s important.” Improving the Prognosis for Mesothelioma The designation stems in part from interim results in November of the ongoing phase II clinical trial that showed increased survival of patients receiving the vaccine in combination with standard chemotherapy. Median overall survival was 18.2 months, compared to 14.2 months for the control group receiving only the chemotherapy. ONCOS-102 demonstrated a broad immune system activation with favorable tolerability and safety, according to investigators. A trial follow-up will be announced in the coming months with the median overall survival expected to rise within the combination cohort. “It’s too early to say I’m confident [that this is the answer to mesothelioma],” Jaderberg said. “But when the most important regulator in the world [the FDA] is telling you they will provide extr...
Source: Asbestos and Mesothelioma News - Category: Environmental Health Authors: Source Type: news