19 May 2016 - Celator Pharmaceuticals today announced that the US FDA granted breakthrough therapy designation to Vyxeos (also known as CPX-351).

Vyxeos is an investigational product in development as a treatment for acute myeloid leukaemia (AML) and other blood cancers.

The breakthrough therapy designation is primarily based upon the positive results from the pivotal Phase 3 clinical trial in older patients with previously untreated high-risk (secondary) AML. The designation is for the treatment of adults with therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC). This designation includes the patient populations enrolled in the Phase 3 clinical trial.

The Phase 3 trial met its primary endpoint demonstrating a statistically significant improvement in overall survival. Data will be presented at the American Society of Clinical Oncology 2016 Annual Meeting on 4 June.

Celator Pharmaceuticals plans to submit a new drug application to the FDA by the end of the third quarter of 2016.

For more details, go to: http://ir.celatorpharma.com/releasedetail.cfm?ReleaseID=971838