FDA Accepts License Application for First Allogeneic “Off-the-Shelf” Cellular Medicine in the US

In late July, the US FDA accepted a Biologics License Application (BLA) from Mesoblast Limited. The BLA was resubmitted for the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD).

If approved, Mesoblast’s “RYONCIL” will be the first allogenic, off-the-shelf cellular medicine in the US, as well as the first cell therapy for children up to 18 years old with the condition.

Mesoblast CEO, Dr. Silviu Itescu said, “We are pleased that FDA has accepted our BLA resubmission for review and look forward to the potential approval of RYONCIL for children with SR-aGVHD.”

Of the application’s acceptance, Dr. Wee Kiat Tan, co-CEO of CytoMed Therapeutics (NASDAQ: GDTC), a pre-clinical biotechnology company focusing on developing off-the-shelf, cell-based immunotherapy cancer treatments, said…

“This is a great advancement for allogeneic cell based therapy as once the approval is obtained, this means that the regulatory and approval pathway has been trailblazed.

“All other allogeneic cell based therapy, including CytoMed’s allogeneic gamma delta T cell cancer therapy can follow this regulatory pathway to bring potentially affordable cell therapy to the masses.”

The FDA has considered Mesoblast’s resubmission to be a complete response to prior inquiries arising from its last submission, and Mesoblast anticipates a decision on or before the FDA’s Prescription Drug User Fee Act (PDUFA) goal date of January 7, 2025.

Read the full article, HERE

Or watch CytoMed Therapeutics’ (NASDAQ:GDTC) latest investor presentation, HERE