Pfizer's Elranatamab Granted FDA Priority Review as Potential Second-in-Class BCMA/CD3 Bispecific Antibody for Relapsed/Refractory Multiple Myeloma

On February 22, Pfizer announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review status to the Biologics License Application (BLA) for its CD3/BCMA bispecific antibody elranatamab, with the FDA expected to make a decision on the application in 2023. This also indicates that elranatamab is expected to become the world’s second approved CD3/BCMA bispecific antibody following teclistamab from Johnson & Johnson / Genmab. Meanwhile, the European Medicines Agency (EMA) has also accepted the Marketing Authorization Application (MAA) for elranatamab.

Elranatamab is designed to bind to BCMA, which is highly expressed on the surface of multiple myeloma (MM) cells, and the CD3 receptor on T cells, activating T cells to kill myeloma cells. The BLA and MAA for elranatamab are primarily based on data from cohort A (BCMA-naïve, n=123) of the MagnetisMM-3 (NCT04649359) trial, an ongoing open-label, multicenter, single-arm Phase II clinical study aimed at evaluating the safety and efficacy of elranatamab monotherapy in patients with relapsed or refractory multiple myeloma (RRMM). Patients included in the study had previously received treatment with at least three classes of therapies, including proteasome inhibitors, immunomodulatory agents, and anti-CD38 monoclonal antibodies.

In the MagnetisMM-3 study, patients received a subcutaneous (SC) injection of elranatamab (76mg, QW) once a week in 28-day cycles. Patients who received six or more cycles of treatment and achieved at least a partial response or better for at least two months could have their dosing interval adjusted to once every two weeks (Q2W).

At a median follow-up of 10.4 months, patients receiving elranatamab as their first BCMA-targeted therapy achieved a high objective response rate of 61% and a very good partial response rate of 55%. The results of MagnetisMM-3 also indicate that elranatamab has manageable safety.

In November 2022, Pfizer, Inc. announced that elranatamab had been granted Breakthrough Therapy Designation by the FDA. Additionally, elranatamab has received Orphan Drug Designation for the treatment of MM from both the FDA and EMA, as well as Fast Track Designation and inclusion in the PRIME scheme. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has also granted elranatamab Innovative Drug Designation. The FDA has included elranatamab in the ORBIS project, a framework for the simultaneous submission and review of oncology products across multiple countries, which may accelerate approvals in certain countries outside the United States.

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