Pharmaceutical Executive November 27, 2023
Pharmaceutical Executive Editorial Staff

AbbVie and Genmab will share commercial responsibilities in the United States and Japan for epcoritamab-bysp (Epkinly), whereas AbbVie will be responsible for further global commercialization.

The FDA has granted Breakthrough Therapy Designation to epcoritamab-bysp (Epkinly; AbbVie and Genmab) for the treatment of adults with follicular lymphoma (FL) that is relapsed or refractory (R/R) following treatment with two or more therapies. Additionally, the European Medicines Agency validated a Type II application for epcoritamab (Tepkinly) for the same indication.1

AbbVie and Genmab, who are co-developing the drug, announced they will share commercial responsibilities in the United States and Japan, whereas AbbVie will be responsible for further global commercialization.

“The FDA granted BTD and validated European application are an important step in our...

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Topics: Biotechnology, FDA, Govt Agencies, Pharma, Pharma / Biotech
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