AbbVie, Genmab Get Conditional Europe OK of Tepkinly Lymphoma Drug
25 9월 2023 - 9:50PM
Dow Jones News
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)
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