GMAB - Genmab files for approval of blood cancer therapy epcoritamab in Japan

• Genmab ( GMAB ) ( GMXAY ) ( OTCPK:GNMSF ) submitted a new drug application (NDA) to Japan's Ministry of Health, Labor and Welfare (MHLW) for subcutaneous epcoritamab (DuoBody-CD3xCD20) to treat patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) who had two or more lines of systemic therapy.
• The filing was backed by data from phase 2 trials — EPCORE NHL-3 and EPCORE NHL-1.
• Epcoritamab is being co-developed by Genmab and AbbVie ( NYSE: ABBV ).
• The drug is also under priority review in the U.S. for similar patient population. The FDA is expected make a decision by May 21.
• GMAB -2.52% to $42.08 premarket Dec. 21

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