Name

FLAG-003

Alternate Names

None

Abbreviations

None

Category

Other therapy

Subcategory

None

NSC Number

None

Primary Site

Brain

Histology

Glioma

Remarks

February 3, 2023 FLAG-003, an investigational small molecule therapy developed by FLAG Therapeutics Inc. for the treatment of diffuse intrinsic pontine glioma—a rare, highly aggressive and difficult to treat brain tumor found in children—has been granted Rare Pediatric Disease designation from FDA.

March 4, 2016: FDA and the European Medicines Agency both granted Orphan Drug Designation to FLAG-003 for the treatment of glioma.

Orphan status is granted by the FDA to promote the development of products that demonstrate promise for treatment of rare diseases, those that affect fewer than 200,000 Americans annually.

CODE: code this drug in Other Treatment, assign code 2.

Coding

Please see remarks for additional information
Glossary