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FDA Grants Orphan Drug Status to Eisai’s Investigational Compound E7777 for Cutaneous T-Cell Lymphoma

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The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Eisai’s investigational compound E7777 for cutaneous T-cell lymphoma.  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.

The Orphan Drug Act allows FDA to grant orphan status to a drug that has the potential for the treatment, diagnosis, or prevention of a rare disease/disorder that affects fewer than 200,000 people in the United States.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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