FDA grants priority review to tafasitamab as part of combination treatment for advanced DLBCL
The FDA granted priority review to tafasitamab in combination with lenalidomide for treatment of patients with relapsed or refractory diffuse large B-cell lymphoma, according to the agent’s manufacturer.
The agency is expected to make a decision on the biologics license application for tafasitamab (MorphoSys AG) — an investigational, humanized Fc-engineered monoclonal antibody directed against CD19 — by Aug. 30.
The application is based on data from the single-arm, phase 2 L-MIND trial — which evaluated tafasitamab in combination with lenalidomide (Revlimid, Celgene) for patients with relapsed or refractory DLBCL who received up to two prior lines of therapy — and a retrospective observational matched control cohort in the Re-MIND trial, which evaluated lenalidomide monotherapy for relapsed or refractory DLBCL in an attempt to isolate the contribution of tafasitamab.
The Re-MIND trial met its primary endpoint, showing a statistically significant improvement in best overall response rate with tafasitamab plus lenalidomide compared with lenalidomide alone.
“We are extremely pleased that the FDA has accepted filing of our application and granted priority review, as we believe that the combination of tafasitamab and lenalidomide may provide an additional treatment option for patients suffering from DLBCL who have relapsed after or are refractory to the current standard of care,” Malte Peters, MD, chief development officer of MorphoSys, said in a company-issued press release.
The FDA previously granted breakthrough therapy designation to the combination of tafasitamab and lenalidomide for relapsed or refractory DLBCL.