Roche obtains FDA approval for its anti-cancer drug Columvi

26. June 2023
-IAM, News

Daniel Pfund, Senior Financial Analyst

Last week, Roche (more specifically, its Genentech division) received approval to market its anti-cancer drug Columvi in the United States. The approval by the Food and Drug Administration (FDA) follows the decision of the European Committee for Medicinal Products for Human Use (CHMP), which had already approved the drug in April.

Columvi is a bispecific antibody for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. This type of cancer represents an aggressive, fast-growing form of non-Hodgkin’s lymphoma, and is one of the most common blood cancers in adults in the United States.

The FDA had recognized this innovative treatment by granting Roche a priority review in April. According to Roche, Columvi is the first antibody of its kind with a fixed duration of action available for the treatment of patients with aggressive lymphoma who have already received several treatments.