U.S. FDA Grants Orphan-Drug Designation for Allogene's ALLO-605 for multiple myeloma

Allogene Therapeutics, Inc. ALLO received Orphan-drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for its drug candidate ALLO-605 for the treatment of patients with multiple myeloma.

ALLO-605 is the next-generation AlloCAR T product candidate targeting BCMA currently being investigated in the phase 1 clinical study. 

The FDA granted Fast Track designation to ALLO-605 in Q2 2021.

Rafael Amado, M.D., Executive Vice President of Research and Development and Chief Medical Officer, said, “Orphan-drug designation marks an important step towards developing our anti-BCMA portfolio for patients with multiple myeloma and making allogeneic CAR T products readily available for patients”.

FDA grants orphan status to support development of medicines for the treatment of rare diseases that affect fewer than 200,000 people in the United States. It also provides benefits of seven-year period of market exclusivity if the drug is approved, tax credits for qualified clinical trials and an exemption from FDA application fees.

Allogene Therapeutics is currently trading high 6.14 percent at $8.98 in pre-market session.