CHMP has recommended the approval of Columvi for DLBCL after two or more lines of systemic therapy

The recommendation is based on results from the Phase 1/2 NP30179 study investigating the safety, efficacy, and pharmacokinetics of Columvi in R/R DLBCL

• Fixed-duration Columvi resulted in early and long-lasting responses in people with heavily pre-treated or refractory DLBCL
• CR was seen in 35.2% with OR seen in 50%
• Columvi-related AEs leading to treatment discontinuation occurred in 3.2% of patients

Columvi was recently approved by Health Canada for the treatment of R/R DLBCL
• US FDA accepted Genentech’s BLA and granted priority review for Glofitamab for the treatment of people with R/R LCBL; approval expected by July 2023

Once approved, Columvi will be the first CD20xCD3 T-cell-engaging bispecific antibody available to treat people in Europe with aggressive lymphoma