Erytech will have to provide additional data before re-applying for market approval in Europe for Graspa. This leukemia therapy uses red blood cells to deliver an enzyme that starves tumors to death.
Erytech is a biotech from Lyon with a visionary approach to treat cancer: using red blood cells as drug carriers. Last year, the company submitted a Marketing Authorization Application (MAA) to attain EU approval for Graspa (eryasp), a treatment for acute lymphoblastic leukemia (ALL). However, Erytech is struggling to provide all the additional data requested and has withdrawn the application. Resubmission is scheduled for mid-2017, once all the data is collected.
In a Phase II/III trial, the treatment proved effective and safe in ALL patients. However, Erytech has been asked for additional data regarding pharmacodynamics, immunogenicity and comparison with conventional drug delivery methods. The main challenge seems to be time to meet the requirements; Gil Beyen, CEO, stated that there are no safety issues and the company is still committed to bringing Graspa to the market.