MorphoSys seeks USFDA nod for antibody Tafasitamab to treat lymphoma

New Delhi: MorphoSys AG announced recently that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for tafasitamab, an anti-CD19 antibody, for the treatment of relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL).

The BLA submission is based on the primary analysis data from the L-MIND trial of tafasitamab in combination with lenalidomide in patients with r/r DLBCL and the retrospective observational matched control cohort Re-MIND evaluating efficacy outcomes of r/r DLBCL patients who received lenalidomide monotherapy.

Tafasitamab (MOR208) is an investigational humanised Fc-engineered monoclonal antibody directed against CD19. Fc-modification of tafasitamab is intended to lead to a significant potentiation of antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), thus aiming to improve a key mechanism of tumor cell killing. Tafasitamab has been observed in preclinical models to induce direct apoptosis by binding to CD19, which is assumed to be involved in B cell receptor (BCR) signaling.

Commenting on the same, Dr Malte Peters, Chief Development Officer of MorphoSys said, “The BLA submission marks a significant milestone in MorphoSys’ history and demonstrates our dedication to address the high medical need in relapsed or refractory DLBCL.”

“If approved, tafasitamab and lenalidomide could become an alternative treatment option for patients with this serious disease, ” Peter added

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The FDA has a 60-day filing review period to determine whether the BLA is complete and acceptable for filing. MorphoSys will communicate the agency’s decision.

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