Elranatamab, a drug developed by Pfizer Receives FDA and EMA Filing Acceptance

NEW YORK-(BUSINESS WIRE)- Pfizer Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the company’s Biologics License 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 designed to divert regulatory authorities’ attention and resources towards pharmaceuticals that, if approved, could offer considerable improvements over existing alternatives for critical illnesses, allowing these drugs to be offered to patients sooner. The FDA is anticipated to make a decision on the application in 2023. Elranatamab’s marketing authorization application (MAA) has also been accepted by the European Medicines Agency (EMA).

“Today, multiple myeloma is a deadly hematologic cancer with a median survival of slightly over five years. As an off-the-shelf medication, BCMA bispecific antibodies signal a new treatment paradigm that has the potential to significantly improve the lives of those suffering from this disease.” remarked Chris Boshoff, M.D., Ph.D., Chief Development Officer, Cancer and Rare Disease, Pfizer Global Product Development. “We feel that elranatamab, if authorised, has the potential to become the next standard of care for multiple myeloma given its positive clinical results and easy subcutaneous route of administration. We look forward to collaborating with the FDA and EMA to offer this new revolutionary treatment to patients worldwide.”

Elranatamab is designed to attach to BCMA on the surface of multiple myeloma (MM) cells and CD3 receptors on the surface of T-cells, bridging them together and activating the T-cells to destroy the MM cells. Elranatamab’s BLA and MAA are primarily based on data from MagnetisMM-3 (NCT04649359), an ongoing, open-label, multicenter, single-arm, Phase 2 research aimed to assess the safety and efficacy of elranatamab monotherapy in patients with RRMM. Patients who have enrolled had previously undergone at least three types of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody.

This study is part of the MagnetisMM clinical research programme, which is expanding to include more patient populations over time, with ongoing registrational-intent trials that investigate elranatamab as monotherapy and in combination with standard or novel therapies in a variety of patient populations ranging from newly diagnosed MM to RRMM. MagnetisMM-5 (NCT05020236) is now enrolling in the double class exposed setting, MagnetisMM-6 (NCT05623020) in transplant ineligible newly diagnosed patients, and MagnetisMM-7 (NCT05317416) as maintenance treatment in newly diagnosed patients following transplant.

Pfizer announced in November 2022 that the FDA has granted elranatamab Breakthrough Therapy Designation. Furthermore, the FDA and the EMA have designated elranatamab as an orphan drug for the treatment of MM. The FDA and EMA have also given elranatamab Fast Track Designation and the PRIME programme for the treatment of RRMM patients, respectively. Elranatamab has been given Innovative Medication Designation and the Innovation Passport by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of MM. The FDA has approved elranatamab for Project ORBIS, which is a framework for the concurrent submission and review of oncology products in order to potentially expedite approvals in certain countries other than the United States; currently, five countries (Switzerland, Canada, Australia, Brazil, and Singapore) have agreed to participate.

About Elranatamab

Elranatamab is a humanised BCMA CD3-targeted experimental off-the-shelf BsAb. BsAbs are a type of cancer immunotherapy that binds to and engages two separate targets at the same time. One arm binds to specific antigens on cancer cells, while the other arm binds to T-cells, bringing the two cell types together. Elranatamab’s binding affinity for BCMA and CD3 has been designed to elicit significant T-cell-mediated anti-myeloma action. Subcutaneous delivery of Elranatamab is more convenient than intravenous administration.

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