Pfizer (PFE) said Wednesday that the US Food and Drug Administration approved its supplemental biologics license application for Adcetris in combination with lenalidomide and a rituximab product for treating adults with relapsed or refractory large B-cell lymphoma, or LBCL.

The therapy is approved for adults with LBCL who have had at least two prior systemic treatments and are ineligible for stem cell transplantation or chimeric antigen receptor T-cell therapy, the drugmaker said.

The approval is based on phase 3 Echelon-3 study data, which demonstrated a significant overall survival improvement in relapsed/refractory diffuse large B-cell lymphoma patients treated with Adcetris in combination with lenalidomide and rituximab, reducing the risk of death by 37% compared to placebo plus lenalidomide and rituximab, the company said.

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