Approval And Market OpportunityThe FDA granted accelerated approval for Epkinly's label expansion in 3L+ FL, making it the only CD20 x CD3 TCE bispecific approved for both DLBCL and FL in the R/R setting.
Positive Clinical DataGenmab presented impressive overall survival data for GEN1046 in refractory lung patients, with a survival rate of 17.5 months, significantly ahead of cross-trial comparison benchmarks.
Regulatory MilestoneThe recent FDA vote to accept MRD-ve as a surrogate for myeloma first-line drug development is very important for Genmab, potentially accelerating the drug's market entry.