Genmab Announces Submission of Japan New Drug Application (JNDA) for Epcoritamab (DuoBody®-CD3xCD20) for the Treatment of Relapsed/Refractory Large B-Cell Lymphoma (LBCL)
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Wednesday, December 21, 2022
Health, FDA, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, AbbVie, Biologics license application, Priority review, Food, Ministry, European Medicines Agency, Regulation of tobacco by the U.S. Food and Drug Administration, BLA, DLBCL, Patient, Safety, MHLW, Marketing, FDA, B-cell lymphoma, MAA, Lymphoid leukemia, Pharmaceutical industry, Genmab, Health
“With this regulatory submission, we are one step closer to potentially delivering epcoritamab as a new therapeutic option to patients in Japan with relapsed and refractory LBCL who are in need of alternative treatments,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Key Points:
- “With this regulatory submission, we are one step closer to potentially delivering epcoritamab as a new therapeutic option to patients in Japan with relapsed and refractory LBCL who are in need of alternative treatments,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
- The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization.
- Genmab recently announced that the Biologics License Application (BLA) for epcoritamab for the treatment or R/R LBCL was accepted for Priority Review by the U.S. Food and Drug Administration (FDA), with an FDA action date of May 21, 2023.
- Additionally, the European Medicines Agency recently validated the Marketing Authorization Application (MAA) for epcoritamab for the treatment of adult patients with R/R DLBCL after two or more lines of systemic therapy.