An immunotherapy treatment called ONCOS-102 has received fast track designation from the FDA as a pleural mesothelioma therapy.
Targovax is a Norweigian company that makes ONCOS-102. The company made the announcement today. It means that ONCOS-102 could be available to help people with pleural mesothelioma sooner.
Fast-track designation is for therapies with the potential to address serious medical conditions that have no good treatments. Right now, there is no cure for pleural mesothelioma and very few viable treatment options. The FDA based its decision on encouraging animal studies and early human trials of ONCOS-102.
Importance of Fast Track Designation
ONCOS-102 is an experimental treatment made from a modified virus. The virus allows ONCOS-102 to overcome one of the biggest challenges in mesothelioma therapy: It targets mesothelioma cells while ignoring healthy cells.
ONCOS-102 already has orphan drug status. That is a special FDA status for drugs that treat very rare illnesses. The fast track designation means it could be approved faster when all the research is in.
The latest test results suggest that ONCOS-102 might help standard mesothelioma chemotherapy work better. In trials, patients who had both ONCOS-102 and chemotherapy had the best results. These patients lived an average of four months longer than those on standard chemotherapy.
The combination treatment is now in Phase 2 trials.
In Search of a Better Mesothelioma Treatment
Mesothelioma is an aggressive cancer. There are very few treatments that can even slow it down. Many patients die of this cancer within 12 to 18 months.
The main treatment for mesothelioma is Alimta. Alimta is an antifolate that received FDA approval in 2004. In 2020, a combination of immunotherapy drugs (Yervoy and Opdivo) also received approval for mesothelioma treatment.
Fast-track designation for ONCOS-102 means mesothelioma patients could get another option sooner. FDA approval normally takes years. But according to Targovax, “Fast-Track products have improved likelihood of receiving Priority Review for a future Biologics License Application (BLA) and may be allowed to submit parts of the application early to shorten review time.”
In the meantime, research is ongoing. Targovax expects to release more data from the ONCOS-102 mesothelioma clinical trials this year.
“Securing this Fast-Track designation is a very important milestone for the ONCOS-102 program,” said Ingunn Munch Lindvig, VP of Regulatory Affairs for Targovax in a statement. “Most importantly, Fast-Track designation validates the strong potential of ONCOS-102 as a future treatment option for solid tumors with high unmet medical need.”
Asbestos exposure is the main cause of mesothelioma. Despite continued pleas from advocacy groups, the US government has refused to ban asbestos.
“Targovax receives Fast-Track designation for ONCOS-102”, February 15, 2021, Targovax news release. Targovax.com/en/targovax-receives-fast-track-designation-for-oncos-102/
“Targovax releases update for mesothelioma trial combining ONCOS-102 and chemotherapy”, Targovax News Release, May 4, 2020, Targovax website, Accessed May 28, 2020, https://www.targovax.com/en/targovax-releases-update-for-mesothelioma-trial-combining-oncos-102-and-chemotherapy/