Shots:

• The US FDA has accepted the BLA for Priority Review of epcoritamab (SC) for r/r LBCL. The US FDA’s decision is expected on May 21, 2023
• The submission was based on the LBCL cohort of the P-II (EPCORE NHL-1) trial evaluating epcoritamab for relapsed, progressive, or refractory CD20+ mature B-NHL which showed efficacy with durable responses. In the total patient population/ CAR T-naïve/ prior treated with CAR T showed ORR (63%/69%/54%) & CR (39%/42%/34%), respectively
• The companies will share commercial responsibilities in the US and Japan & AbbVie will lead the global commercialization. The therapy is being evaluated in the ongoing P-III trial for r/r DLBCL & FL

Ref: Businesswire | Image: AbbVie