Pharma Focus Asia

Pfizer’s Elranatamab Receives FDA and EMA Filing Acceptance

Wednesday, February 22, 2023

Pfizer announced today that the U.S. Food and Drug Administration (FDA) has granted priority review for the Biologics Licence Application (BLA) for elranatamab, an investigational B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody (BsAb), for the treatment of patients with relapsed or refractory multiple myeloma (RRMM). Priority Review is intended to direct attention and resources from regulatory authorities toward drugs that, if approved, will offer significant improvements over existing options for serious conditions in order to make these drugs available to patients faster.

Multiple myeloma is a fatal haematologic malignancy, with a median survival of just over five years. As an off-the-shelf treatment, BCMA bispecific antibodies are heralding a new treatment paradigm which greatly impact the lives of people with this disease. Elranatamab, if approved, will become the next standard of care for multiple myeloma by offering favourable clinical results and convenient subcutaneous route of administration.

Elranatamab is an investigational, off-the-shelf, humanised BCMA CD3-targeted BsAb. BsAbs are a novel form of cancer immunotherapy that bind to and engage two different targets at once. One arm binds directly to specific antigens on cancer cells and the other arm binds to T-cells, bringing both cell types together. The binding affinity of elranatamab for BCMA and CD3 has been engineered to elicit potent T-cell-mediated anti-myeloma activity. Elranatamab is administered subcutaneously, to offer more convenience over intravenous administration.

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