USFDA accepts application for Roche Columvi combination for relapsed or refractory diffuse large B cell lymphoma

The sBLA is based on results from the phase III STARGLO study, which were presented at the European Hematology Association Congress earlier this year and recently published in The Lancet. Data showed Columvi in combination with GemOx demonstrated a statistically significant and clinically meaningful overall survival (OS) improvement versus MabThera/Rituxan (rituximab) and GemOx (R-GemOx). Safety of the combination appeared consistent with the known safety profiles of the individual medicines.

Data from the STARGLO study have been submitted to other health authorities around the world for approval consideration, including the European Medicines Agency.

Columvi is part of Roche’s CD20xCD3 bispecific antibody programme, which has seen more than 3,000 patients treated in clinical trials and more than 2,600 treated in clinical practice to date. Columvi was a fixed-duration bispecific antibody to receive accelerated approval by the U.S. FDA and conditional marketing authorisation in the EU as a monotherapy to treat people with R/R DLBCL after two or more lines of systemic therapy and is currently approved in more than 50 countries around the world.

"As part of Roche’s efforts to elevate treatment standards in the earlier stages of DLBCL, where there is the best opportunity to improve long-term outcomes and prevent relapse, Columvi is also being investigated in combination with Polivy® (polatuzumab vedotin), MabThera/Rituxan, cyclophosphamide, doxorubicin and prednisone (R-CHP) in previously untreated DLBCL in the phase III SKYGLO study," the release stated.