Therapy Areas: Oncology
Ultimovacs secures FDA Fast Track for UV1 cancer vaccine in unresectable mesothelioma
5 February 2024 -

Norway-based clinical-stage biotechnology company Ultimovacs (OSE:ULTI) announced on Monday that it has received Fast Track designation from the US Food and Drug Administration (FDA) for its UV1 therapeutic cancer vaccine.

This designation was granted for UV1 in combination with ipilimumab and nivolumab for the treatment of patients with unresectable malignant pleural mesothelioma, including those in the first-line setting, to improve overall survival. The FDA's decision was based on positive results obtained in the Phase II clinical trial NIPU, which demonstrated improved survival rates when UV1 was administered alongside ipilimumab and nivolumab immunotherapy.

Fast Track status expedites the drug development and review process for serious conditions, allowing Ultimovacs more frequent discussions with the FDA regarding UV1's treatment path for mesothelioma. This designation underscores the potential of UV1 in addressing the urgent medical needs of patients with this challenging cancer type. Mesothelioma, characterised by its aggressiveness and limited treatment options, often arises from asbestos exposure and presents significant challenges in management and care.

UV1 has previously received Orphan Drug Designation for mesothelioma treatment, as well as Fast Track designation as an add-on therapy to ipilimumab or pembrolizumab for the treatment of unresectable or metastatic melanoma.