FDA Grants Vyxeos Breakthrough Therapy Status for AML
Celator announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Vyxeos (CPX-351) for the treatment of adults with therapy-related acute myelogenous leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).
The designation is primarily based on positive results from the Phase 3 trial in older patients with previously untreated high-risk (secondary) AML. The study met its primary endpoint demonstrating a statistically significant improvement in overall survival for the Vyxeos arm compared to the 7+3 arm (median 9.56 months vs. 5.95 months, respectively). In addition, Vyxeos showed a 31% reduction in the risk of death vs. the 7+3 treatment (HR 0.69, P=0.005). The sixty-day all-cause mortality was 13.7% vs. 21.2%, in favor of patients treated with Vyxeos. Detailed study data will be presented at the American Society of Clinical Oncology (ASCO) 2016 Annual Meeting in June.
Celator intends to submit a New Drug Application (NDA) to the FDA by the end of the third quarter of 2016.
Vyxeos is an investigational, nano-scale, liposomal formulation of cytarabine and daunorubicin incorporated by the company's proprietary CombiPlex platform.
For more information visit Celatorpharma.com.