February 20, 2024 was an exciting day!

I wrote in an earlier post about advancements in targeting mutations in Isocitrate Dehydrogenase (IDH) as a potential therapeutic approach.  On February 20, 2024, Servier confirmed in a twitter post the filing of their New Drug Application (NDA) with the FDA.  

The 'Newsroom' post on the Servier US website (at servier.us/blog/fda-and-ema-accept-vorasidenib-regulatory-submissions...) further confirms the 'clock start date' under a priority review that accompanies a breakthrough therapy designation, meaning that the FDA and Servier commit to a six month review and final decision / action on the NDA by August 20, 2024.

By filing under the Project Orbis framework established by the FDA's Oncology Center of Excellence, this allows for concurrent and collaborative review across the US FDA, Australia's TGA, Brazil's ANVISA, Canada's Health Canada, Israel's Ministry of Health, Singapore's Health Sciences Authority, Switzerland's Swissmedic, United Kingdom's MHRA).  

With the FDA NDA submission under Project Orbis and Marketing Authorization Application with the European Medicines Agency, and Canada facilitating review with Canada's Drug and Health Technology Agency (CADTH) and pan-Canadian Oncology Drug Review (pCODR) Expert Review Committee (pERC), this application should have the right expert review prioritized for rapid assessment.  If justified after detailed assessment of efficacy and safety, this means that this new medicine could be on pharmacy shelves in Canada, the US, Europe and elsewhere in just six months.  It will be the first notable progress in the treatment of incurable / terminal Low Grade Glioma that the world has seen in more than two decades.

February 20th was a good day, indeed!