Genmab Gets FDA Orphan Designation to Epcoritamab in Follicular Lymphoma

 Genmab AS on Tuesday said the U.S. Food and Drug Administration granted orphan-drug designation to the investigational drug epcoritamab for the treatment of follicular lymphoma.

The Copenhagen biotechnology company is co-developing epcoritamab with North Chicago, Ill., biopharmaceutical company AbbVie Inc. under a 2020 collaboration.

The FDA's orphan-drug program gives special status to drugs and biologics for diseases and disorders that affect fewer than 200,000 people in the U.S. and provides for an extended marketing exclusivity period against competition.

Genmab said epcoritamab is currently under evaluation in several clinical trials as a treatment option for patients with follicular lymphoma, a slow-growing form of non-Hodgkin's lymphoma that accounts for about 25% of adult cases.

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