Roche reports CHMP recommends EU approval of fixed-duration Columvi

Roche announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use, or CHMP, has recommended the approval of Columvi for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, or DLBCL, after two or more lines of systemic therapy. A final decision is expected from the European Commission in the "near future," the company said. "New therapeutic options that are readily and broadly available are urgently needed for people with relapsing diffuse large B-cell lymphoma, which can become fatal without immediate treatment. The CHMP’s recommendation for Columvi brings us closer to providing a new, fixed-duration therapy for people with diffuse large B-cell lymphoma that induces early and long-lasting responses," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development.