Roche Blood Cancer Drug Columvi Achieves Approval in Europe 41 Percent Survival Boost

Swiss pharmaceutical giant Roche has announced that its blood cancer drug Columvi, in combination with gemcitabine and oxaliplatin (GemOx), has secured approval from the European Commission for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL).

This marks the first bispecific antibody regimen available in Europe for DLBCL patients whose cancer has returned or failed to respond to initial therapies. The approval follows results from a phase III study, which demonstrated that Columvi and GemOx reduced the risk of death by 41% and the risk of disease progression or death by 63%.

At a median follow-up of 20.7 months, patients treated with the combination therapy showed a median overall survival of 25.5 months. Franck Morschhauser, the study investigator, highlighted that this therapy addresses a critical need for patients with primary refractory disease or early relapse, offering an effective and accessible treatment option.

Columvi is a CD20xCD3 bispecific antibody, which engages T-cells and B-cells to release cancer-killing proteins. Roche is investigating the drug as a monotherapy and in combination with other treatments for DLBCL and mantle cell lymphoma.

Besides Europe, Columvi received accelerated approval in the US in June 2023, based on its performance in the Phase I/II NP30179 study. The drug’s sales soared from CHF 28 million ($32 million) in 2023 to CHF 172 million ($190 million) in 2024, reflecting a six-fold increase in demand.