FDA ready to review novel cancer vaccine Platform TechnologyAugust 04, 2024 - The FDA's Peter Marks believes the FDA’s yet-to-be-formalized platform technology designation could be helpful.
The FDA recently issued draft guidance on the “advanced manufacturing technology” designation program, which was developed as part of the Food and Drug Omnibus Reform Act of 2022. The initiative is viewed as a step to facilitate the development of products based on novel technologies to improve the drug production process. The agency is still separately working on the specifics of the “platform” designation. The idea would be that products developed with the same platform technologies may enjoy streamlined reviews for subsequent advances. The FDA has had the “platform” idea for some time. But it hasn’t really applied the idea to the fullest extent possible, Marks said.
“I think the mRNA platforms are going to force us to really try to lean into that," Marks added.
ONCY's pelareorep is a platform technology, that is able to address multiple cancers, with/without immune checkpoint inhibitors, ADCs bispecifics, chemotherapy, and small molecules like CDK4/6 and PARP inhibitors, as previously outlined.
https://www.fiercebiotech.com/biotech/were-open-business-fdas-peter-marks-says-agency-ready-review-novel-cancer-vaccines-despite