21.07.2023 11:57:48

AbbVie/Genmab's Diffuse Large B-cell Lymphoma Drug A Step Away From Approval In Europe

(RTTNews) - Drug major AbbVie Inc. (ABBV) announced on Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use, or CHMP, has taken a positive opinion to grant conditional marketing authorization for Epcoritamab to treat relapsed or refractory diffuse large B-cell lymphoma in adults.

The final European Commission decision on Epcoritamab is expected later this year.

Epcoritamab is being co-developed by AbbVie and Genmab as part of the companies' oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan with AbbVie overseeing further global commercialization.

If approved, Epcoritamab will be commercially available in all EU member states along with Liechtenstein, Norway, and Iceland, and will be marketed under the brand name TEPKINLY.

"DLBCL is an aggressive cancer that develops in the lymphatic system. It is the most common type of B-cell NHL worldwide and accounts for approximately 30 percent of all global cases", the company said in a statement.

In pre-market activity, shares of AbbVie are trading at $142.21, up 0.01% on the New York Stock Exchange.

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