AbbVie, Genmab Get Conditional Europe OK of Tepkinly Lymphoma Drug
By Colin Kellaher
AbbVie and Genmab have won conditional European approval of Tepkinly in certain patients with an aggressive type of non-Hodgkin lymphoma.
The companies on Monday said the approval covers Tepkinly as a monotherapy for adults with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy.
The European Commission grants conditional marketing authorization to medicines that address an unmet medical need, where the benefit outweighs the risk of limited data availability. AbbVie and Genmab will need to provide confirmatory comprehensive data to maintain the marketing authorization.
North Chicago, Ill., biopharmaceutical company AbbVie and Copenhagen biotechnology company Genmab are co-developing Tepkinly under a 2020 collaboration.
The U.S. Food and Drug Administration in May granted accelerated approval of the drug, marketed in the U.S. as Epkinly, for adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma.
Genmab separately on Monday said Japan's Ministry of Health, Labour and Welfare approved Epkinly for adults with certain types of relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma and follicular lymphoma grade 3B, after two or more lines of systemic therapy.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
September 25, 2023 08:35 ET (12:35 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.-
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