- NHL Treatment
- Hodgkin's Treatment
- Clinical Trials
- Monoclonal Antibodies
- Types of NHL
Lymphoma and Pets
FDA Grants Orphan Status to CTCL Drug
The U.S. Food and Drug Administration has granted orphan drug designation to Eisai Inc. for its investigational compound E7777 for cutaneous T-cell lymphoma (CTCL).
The Orphan Drug Act (ODA) allows the FDA to grant orphan status to a drug the agency believes has the potential for the treatment, diagnosis, or prevention of a rare disease or disorder that affects fewer than 200,000 people in the United States.
E7777 is designed to have an improved purity profile and manufacturing process. It is currently in a pivotal trial intended to support its submission for approval against CTCL.
CTCL is a rare type of cancer that begins in the white blood cells and attacks the skin. It is one of several types of lymphoma collectively called non-Hodgkin's lymphoma.
Eisai Inc. is the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd. Its portfolio and focus includes oncology and specialty care, including Alzheimer's disease, epilepsy and metabolic disorders.