ERYTECH Pharma, the French biopharmaceutical company developing ‘tumor starvation’ treatments for acute leukemia and other oncology indications, is withdrawing the current MAA for GRASPA for the treatment of acute lymphoblastic leukemia (ALL).
The company said that the reason for withdrawal was shortage of the time allowed in the CHMP procedure to provide the additional data requested in the CHMP’s Day 180 List of Outstanding Issues (LOI). Erytech said it would resubmit an MAA around mid-2017.
Following positive efficacy and safety results from the completed European Phase 2/3 pivotal study in patients with relapsed and refractory ALL, ERYTECH submitted an MAA for GRASPA in September 2015. Erytech received the Day 180 LOI in September 2016 and has been in discussion with the Rapporteur/Co-rapporteur and the CHMP to provide the requested additional data regarding the comparability between the old and new form of asparaginase encapsulated in GRASPA and the development of a new immunogenicity assay, as well as the pharmacodynamics effects of eryaspase.
“It is disappointing that assembling the data necessary to properly address the remaining questions is requiring longer time than we were actually granted at this stage. Our pivotal trial demonstrated improved clinical outcome and an excellent safety profile with eryaspase compared to native asparaginase. We are committed to pursuing regulatory approval for GRASPA and intend to work closely with our investigators and advisors to generate the additional information requested and to resubmit an MAA next year” said Iman El-Hariry, Chief Medical Officer of ERYTECH.
“The decision to withdraw at this stage was not an easy one, but does not change our commitment to bringing eryaspase to the market.” said Gil Beyen, ERYTECH’s Chairman and Chief Executive Officer. “We believe we have generated strong clinical data in our different programs of eryaspase, and we continue to execute our plans towards making the product available to patients with aggressive forms of cancer, such as acute lymphoblastic leukemia, acute myeloid leukemia and pancreatic cancer. We are not aware of any safety issues and our other clinical trials are not affected. We will continue to pursue our planned clinical strategy in ALL and AML in close collaboration with our European partner Orphan Europe (Recordati Group)”.