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# OBI Pharma Granted Orphan Status for Leukemia Drug
- URL: https://www.fdaweb.com/obi-pharma-granted-orphan-status-for-leukemia-drug/
- Published: 2018-09-20T12:00:00.000Z
- Updated: 2026-09-15T00:33:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142402

FDA has granted OBI Pharma an orphan drug designation for OBI-3424 for treating acute lymphoblastic leukemia. OBI-3424 is a first-in-class DNA alkylating cancer therapeutic agent targeting aldo-keto reductase 1C3 overexpressing cancers, the company says. In July, the therapy was granted orphan status for treating hepatocellular carcinoma (HCC). A Phase 1/2 study is underway in patients with solid tumors, including HCC and castrate-resistant prostate cancer at the University of Texas M.D. Anderson Cancer Center.