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AbbVie and Genmab Report the US FDA Acceptance of BLA for Priority Review of Epcoritamab to Treat Large B-Cell Lymphoma

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AbbVie and Genmab Report the US FDA Acceptance of BLA for Priority Review of Epcoritamab to Treat Large B-Cell Lymphoma

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

Click here to­ read the full press release 

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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