Tuesday, Genmab A/S (GMAB) and AbbVie (ABBV) revealed that the FDA has given a Priority Review to the supplemental Biologics License Application or sBLA for Epcoritamab-bysp, a product of the collaboration between the two companies.
This is a T-cell engaging bispecific antibody administered subcutaneously, intended for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma after undergoing two or more lines of systemic therapy.
The sBLA is supported by data from the Phase 1/2 EPCORE NHL-1 clinical trial, showing high overall and complete responses in R/R FL patients treated with epcoritamab.
The companies will divide commercial responsibilities in the U.S. and Japan, with AbbVie handling global commercialization.
The FDA has set a Prescription Drug User Fee Act or PDUFA target action date of June 28, 2024.
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April 17, 2026 15:29 ET The ongoing conflict in the Middle East continues to raise concerns for policymakers who worry about the impact of the supply shock and high energy prices on the real economy. Producer price data and various survey results on the housing market were the main news from the U.S. this week. In Europe, industrial production data for the euro area gained attention. GDP figures out of China and the policy move by the Singapore central bank were in focus in Asia.