ERYTECH provides regulatory update on Graspa for hypersensitive acute lymphoblastic leukemia.
ERYTECH Pharma provided a regulatory update, announcing that it is no longer seeking approval for Graspa in hypersensitive acute lymphoblastic leukemia (ALL) following feedback from the FDA
Following positive results of a Phase II trial, sponsored by the Nordic Organization for Paediatric Haematology and Oncology (NOPHO), presented at the 2020 American Society of Hematology annual meeting, Erytech has been in discussions with the FDA for the approval of Graspa to treat ALL patients who had previously experienced hypersensitivity reactions to pegylated asparaginase therapy. A meeting to discuss the submission of a Biologics License Application (BLA) took place in June 2021, after which the Company confirmed its intention to submit a BLA, subject to the submission of additional requested information to the FDA and agreement on an Initial Pediatric Study Plan (iPSP).
The Company recently received feedback from the FDA on its iPSP, submitted in July 2022. After thorough evaluation of this feedback, which included a new request for additional data, and taking into account the changing competitive landscape in the treatment of hypersensitive ALL, the Company has determined that it is in the best interests of the Company and its shareholders to no longer seek approval for Graspa in ALL and to focus its resources on its preclinical programs and strategic partnering activities.
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