FDA Grants Fast Track for New Acute Myeloid Leukemia Treatment


VOR33 aims to protect an individual’s healthy cells from anti-CD33 therapies and replace standard care transplants.

The FDA has granted fast track designation to VOR33, Vor Biopharma’s hematopoietic stem cell therapeutic candidate to treat acute myeloid leukemia (AML).

“Receiving fast track designation is an important milestone for Vor, which signals the FDA’s recognition of the serious and life-threatening medical condition of patients facing acute myeloid leukemia and the potential of VOR33 to address this unmet medical need,” Robert Pietrusko, PharmD, chief regulatory and quality officer at Vor, said in a statement.

“We will continue to work closely with the FDA to expedite the development of VOR33, which is now actively enrolling in its Phase 1/2a clinical trial for AML patients who currently have limited treatment options,” he said. “We continue to remain on-track to report VOR33’s initial clinical data in the first half of 2022.”

Vor designed VOR33 to protect an individual’s healthy cells from anti-CD33 therapies, such as VCAR33 or emtuzumab ozogamicin, and to replace standard care transplants for individuals with AML who are at risk for relapse.

Fast track designation expedites reviews of products that will help treat serious, and life-threating conditions and therapeutic candidates with fast track designation can be eligible for priority review.

VOR33 is the lead product candidate of Vor.


PureTech founded entity Vor Biopharma announces VOR33 granted U.S. Fast Track designation for Acute Myeloid Leukemia. Business Wire. News release. September 10, 2021. Accessed September 10, 2021. https://www.businesswire.com/news/home/20210909006184/en

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