Release Date: 29-Sep-2021
ALLO-715 drug which is used for the treatment of multiple myeloma has been granted orphan drug designation by the US FDA. ALLO-715, an AlloCAR T therapy targeting B-cell maturation antigen (BCMA), is a potential novel treatment for multiple myeloma and other BCMA-positive malignancies. Multiple myeloma is characterized by abnormalities in plasma cells that reproduce uncontrollably in the bone marrow and other disease sites and it originates in the bone marrow.
MM is incurable for most patients. Initial results from the Phase 1 Universal study of ALLO-715 in relapsed/refractory multiple myeloma were presented in December 2020 at an oral session of the American Society of Hematology (ASH) annual meeting. In April 2021, ALLO-715 was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. Food and Drug Administration (FDA).
The FDA's orphan-drug program gives special status to drugs and biologics for diseases and disorders that affect fewer than 200,000 people in the U.S and it also gives several benefits, like tax credits for qualified clinical trials, potential seven years of market exclusivity after approval and exemption from user fees.