By Adria Calatayud

Roche Holding said Friday that it has received approval from the U.S. Food and Drug Administration for Columvi, a treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma.

The Swiss pharmaceutical giant said it obtained an accelerated approval based on data from an early-stage Phase 1 and 2 study, and that continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial.

In the Phase 1 and 2 study, the drug showed a 56% overall response rate and a median duration of response of more than 18 months, the company said.

Roche said Columvi will be available in the U.S. in the coming weeks.

Write to Adria Calatayud at adria.calatayud@dowjones.com

(END) Dow Jones Newswires

June 16, 2023 01:29 ET (05:29 GMT)

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