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FDA Nod For Roche’s Columvi Brings Third Anti-CD20 Bispecific To Market

 
• By Alaric DeArment

The company is touting the drug’s fixed-duration treatment as an advantage for patients, while the new drug class has ignited discussion around their use in the community oncology setting.

Roche's Genentech won FDA accelerated approval for Columvi in DLBCL • Source: Shutterstock

The already hot competitive landscape for CD20xCD3-directed bispecific antibodies in non-Hodgkin lymphomas got hotter with the US Food and Drug Administration accelerated approval of Roche Holding AG/Genentech, Inc. ’s Columvi (glofitamab-gxbm). The company is touting its fixed-duration treatment as an advantage for patients needing time off therapy, while the growth of the new class had already sparked discussion among oncologists about the potential for use of the drugs beyond the academic setting.

Genentech announced the FDA nod for Columvi on 15 June. Columvi’s clearance follows by less than a month the FDA’s accelerated approval on 22 May for Genmab A/S and AbbVie Inc.’s Epkinly (epcoritamab-bysp) for DLBCL not otherwise specified, including DLBCL arising from indolent lymphoma and high-grade B-cell lymphoma after two or more lines of therapy

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