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# Celator Pharma Plans NDA for Leukemia Therapy
- URL: https://www.fdaweb.com/celator-pharma-plans-nda-for-leukemia-therapy/
- Published: 2016-05-19T12:00:00.000Z
- Updated: 2026-09-14T21:03:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135722

Celator Pharmaceuticals says it plans to file an NDA in the third quarter of this year for Vyxeos (also known as CPX-351), an investigational drug in development for treating *acute myeloid leukemia (AML)* and other blood cancers. The agency recently granted the therapy a breakthrough designation based on positive results from a pivotal Phase 3 clinical trial in older patients with previously untreated high-risk (secondary) AML, according to the company. The Phase 3 trial met its primary endpoint demonstrating a statistically significant improvement in overall survival (9.56 months for Vyxeos vs. 5.95 months for a comparator), it says. Data will be presented at the American Society of Clinical Oncology 2016 Annual Meeting 6/4.