CHMP recommends EU approval of Roche ’s fixed-duration Columvi (glofitamab) for people with relapsed or refractory diffuse large B-cell lymphoma

Once approved,Columvi will be the first CD20xCD3 T-cell-engaging bispecific antibody available to treat people in Europe with this aggressive lymphomaThe recommendation is based on results from the phase I/II NP30179 study, whereColumvi given as a fixed course induced early and long-lasting complete responses in people with heavily pre-treated or refractory diffuse large B-cell lymphoma1Columvi is part of Roche ’s industry-leading CD20xCD3 T-cell-engaging bispecific developmentprogramme, which aims to transform the treatment experience for people with blood cancers using off-the-shelf and fixed-duration optionsBasel, 26 April 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency ’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Columvi® (glofitamab), for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Columvi has the potential to cha nge the current standard of care in DLBCL. As well as inducing early and long-lasting responses in people with heavily pre-treated or refractory DLBCL, potentially allowing patients a treatment free period, Columvi is designed to be given for a fixed period of time so that people know when their tre atment will end. It is also an off-the-shelf therapy, meaning that people do not have to wait for cell collection and genetic engineering before starting treatment, whic...
Source: Roche Investor Update - Category: Pharmaceuticals Source Type: news