Tafasitamab receives a positive opinion from the EMA CHMP for the treatment of R/R DLBCL

On June 24, 2021, it was announced that tafasitamab received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for use in combination with lenalidomide to treat adult patients with relapsed or refractory (R/R) diffuse large B‑cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant.

The positive opinion recommends the conditional marketing authorization of tafasitamab plus lenalidomide followed by tafasitamab monotherapy. The combination has demonstrated encouraging response rates in the open-label, multicenter, single-arm, phase II L-MIND trial (NCT02399085). Results from this study aided the positive opinion, and the combination was previously approved by the U.S. Food and Drug Administration (FDA) as second-line treatment for adult patients with R/R DLBCL.

For more information on the value of the anti-CD19 monoclonal antibody in the treatment of DLBCL, watch the interview with Lymphoma Hub Chair Gilles Salles, below.