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The treatment is approved for conditional marketing authorization.
AbbVie announced that Tepkinly has been approved for conditional marketing authorization by the European Commission.
Tepkinly is a monotherapy for patients suffering from relapsed or refractory diffuse large B-cell lymphoma and have had at least two lines of systemic therapy.
In a press release, AbbVie’s chief medical officer and senior vice president of development and regulatory affairs Roopal Thakkar said, “The European Commission approval of epcoritamab represents a significant milestone in our aspiration with Genmab to develop a potential core therapy for patients with B-cell malignancies, like DLBCL. With this milestone achievement, TEPKINLY is now the second approved cancer treatment in the EU from our oncology portfolio, and AbbVie's third blood cancer medicine across the world. We remain committed to developing new innovative medicines that help improve the lives of people with hematological cancers."
According to the press release, the European Commission based its conditional approval on the results of the Epcore NHL-1 Phase ½ open-label, multi-cohort, multi-center, single-arm trial that evaluated the efficacy and safety of Tepkinly.
(Sept. 25, 2023); AbbVie; AbbVie Announces European Commission Approval of Tepkinly (Epcoritamab) for Adults with Relapsed or Refractory Diffuse Large B-Cell Lymphoma; https://news.abbvie.com/news/press-releases/abbvie-announces-european-commission-approval-tepkinly-epcoritamab-for-adults-with-relapsed-or-refractory-diffuse-large-b-cell-lymphoma.htm