Biotechnology company Genmab A/S recently shared that its investigational therapy epcoritamab (DuoBody-CD3xCD20), being developed with AbbVie, was granted Orphan Drug designation from the FDA. The therapy is designed for those with follicular lymphoma, a form of non-Hodgkin’s lymphoma (NHL).
GenMab describes epcoritamab as:
a proprietary bispecific antibody created using Genmab’s DuoBody® technology, jointly owned by Genmab and AbbVie Inc. It targets CD20 on the B-cells, a clinically well-validated target that is expressed in a wide variety of B-cell malignancies.
Outside of follicular lymphoma, epcoritamab is also being developed in the pipeline for Richter’s syndrome, chronic lymphocytic leukemia (CLL), and diffuse large B-cell lymphoma (DLBCL). To learn more about epcoritamab and its current clinical trials, take a look at this helpful guide from GenMab.
The FDA recently granted Orphan Drug designation to epcoritamab for the treatment of follicular lymphoma. Orphan Drug designation is granted to drugs or biologics intending to treat, diagnose, or prevent a rare disease or condition. In the United States, “rare” is any condition affecting 200,000 Americans or fewer. The drug developer also earns benefits for this status, including fee waivers, tax credits, increased regulatory assistance, and 7 years of market exclusivity upon approval.
What is Follicular Lymphoma?
Follicular lymphoma is, in most cases, a slow-growing cancer. It occurs in lymph nodes throughout the body, but may also form within the bone marrow. Altogether, follicular lymphoma arises from B-lymphocytes, a type of cell which normally plays a role in immune health. As these B-lymphocytes develop DNA mutations, the cells become abnormal, accumulate, and crowd out healthy cells, preventing the body from adequately fighting infection and causing a variety of health issues. Follicular lymphoma is most common in older individuals. Symptoms associated with follicular lymphoma include:
- Swollen but painless lymph nodes in the groin, neck, abdomen, or underarms
- Shortness of breath
- Appetite loss
- General bodily aches and pains
- Unintended weight loss
- Drenching night sweats
Learn more about follicular lymphoma.