The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to ALX Oncology Holdings’ (NASDAQ:ALXO) Evorpacept for the treatment of patients with acute myeloid leukemia (AML).
Evorpacept in combination with venetoclax and azacitidine is being evaluated in the Phase 1/2 ASPEN-05 study in patients with previously untreated AML who are not candidates for intensive induction therapy or with relapsed/refractory AML.
Sophia Randolph, Chief Medical Officer, commented : “Receiving orphan drug designation in AML, and previously in gastric cancer, from the FDA is an important regulatory milestone and reflects the FDA's recognition of evorpacept's potential to improve clinical outcomes in patients with these advanced cancers.”
Acute Myeloid Leukemia (AML) is an aggressive blood cell cancer that can rapidly progress and lead to death if not treated promptly.
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.
ALX Oncology shares are trading up 12 percent at $9 on Wednesday during pre-market session.
