FDA grants fast track designation to mocravimod with HSCT for acute myeloid leukemia
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The FDA granted fast track designation to mocravimod in combination with allogeneic hematopoietic stem cell transplantation for post-remission therapy of acute myeloid leukemia.
Mocravimod (KRP203, Priothera) is a synthetic sphingosine 1-phosphate receptor modulator.
The agent demonstrated promise in a phase 1B/phase 2A study of patients with hematologic malignancies, according to a Priothera-issued press release.
The phase 2B/phase 3 MO-TRANS study will evaluate the efficacy and safety of mocravimod as adjunctive and maintenance therapy for adults with AML who are undergoing allogeneic HSCT.
The study — expected to start in the second half of this year — will be conducted in the United States, Europe and Japan.
“The fast track designation [granted] for mocravimod in combination with allogeneic HSCT is an important milestone and underlines the significant unmet need [for patients with AML] undergoing HSCT, a serious disease where currently no available therapy exists,” Karen Von Graevenitz, head of regulatory affairs at Priothera, said in the release.
The FDA previously granted orphan drug designation to mocravimod for this indication.
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