Roche says CHMP recommends EU approval of Columvi combination

Roche (RHHBY) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of Columvi in combination with gemcitabine and oxaliplatin for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified who are ineligible for autologous stem cell transplant. The standard second-line therapy for R/R DLBCL patients has historically been high-dose chemotherapy followed by stem cell transplant. “If approved, this Columvi combination could provide a much-needed, off-the-shelf treatment option. A final decision is expected from the European Commission in the near future,” Roche stated.