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# Vor Biopharma ‘Fast Track’ for AML Therapy
- URL: https://www.fdaweb.com/vor-biopharma-fast-track-for-aml-therapy/
- Published: 2021-09-10T12:00:00.000Z
- Updated: 2026-09-14T17:14:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150125

FDA has granted Vor Biopharma a fast track designation for VOR33, Vor’s engineered hematopoietic stem cell therapeutic candidate for treating acute myeloid leukemia (AML). The therapy comprises CRISPR genome-edited hematopoietic stem and progenitor cells that have been engineered to lack CD33, according to the company. “Once infused, VOR33 is designed to protect patients’ healthy cells from anti-CD33 therapies, such as VCAR33 or Pfizer’s Mylotarg (gemtuzumab ozogamicin),” it says.

Vor says it is enrolling AML patients who have limited treatment options in its Phase 1/2a clinical trial. The company says it expects to report initial clinical data in the first half of 2022\. Vor is also exploring the use of its genome-engineered hematopoietic stem cell platform in combination with multiple therapeutic modalities.