FDA Grants ERY-ASP Orphan Drug Designation for AML

Share this content:
FDA Grants ERY-ASP Orphan Drug Designation for AML
FDA Grants ERY-ASP Orphan Drug Designation for AML

Erytech Pharma announced that ERY-ASP has been granted Orphan Drug Designation by the FDA for the treatment of acute myeloid leukemia (AML).

ERY-ASP is a new enzyme formulation of L-asparaginase, which exerts its therapeutic effect by entrapping and protecting the enzyme inside homologous red blood cells. By encapsulating the asparaginase enzyme in red blood cells, ERY-ASP targets leukemia cells through “starvation” while significantly reducing the side effects for patients.

RELATED: Hematologic Cancers Resource Center

AML is the most common form of acute leukemia that affects about 34,000 new patients per year in the US and Europe, mainly adults and older patients, for which few therapeutic options are available today. The filing was based on a positive safety review of the first 30 patients treated in the ongoing Phase 2b study. If approved, ERY-ASP will be granted seven years of marketing exclusivity.

For more information visit Erytech.com.

Related Resources

You must be a registered member of Cancer Therapy Advisor to post a comment.

Sign Up for Free e-newsletters

Regimen and Drug Listings


Bone Cancer Regimens Drugs
Brain Cancer Regimens Drugs
Breast Cancer Regimens Drugs
Endocrine Cancer Regimens Drugs
Gastrointestinal Cancer Regimens Drugs
Gynecologic Cancer Regimens Drugs
Head and Neck Cancer Regimens Drugs
Hematologic Cancer Regimens Drugs
Lung Cancer Regimens Drugs
Other Cancers Regimens
Prostate Cancer Regimens Drugs
Rare Cancers Regimens
Renal Cell Carcinoma Regimens Drugs
Skin Cancer Regimens Drugs
Urologic Cancers Regimens Drugs