The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for elranatamab for the treatment of patients with relapsed or refractory multiple myeloma (RRMM).
Elranatamab is a B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody. The investigational drug is designed to elicit potent T-cell-mediated anti-myeloma activity by binding to BCMA on the surface of multiple myeloma cells and CD3 receptors on the surface of T-cells.
The BLA is supported by data from cohort A of the open-label, single-arm phase 2 MagnetisMM-3 study (ClinicalTrials.gov Identifier: NCT04649359), which included patients with RRMM who were refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody. The primary endpoint was objective response rate.
After a median follow-up of 10.4 months, the objective response rate was 61%, of which 55% had a very good partial response rate or better. The probability of patients maintaining the response at 9 months was 84%.
The rate and severity of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) were mitigated with a 2-step-up priming dose regimen. All cases of CRS (majority occurred after the first or second dose) and ICANS were reported to be grade 1 or 2.
“As an off-the-shelf treatment, BCMA bispecific antibodies are heralding a new treatment paradigm that can greatly impact the lives of people with this disease,” said Chris Boshoff, MD, PhD, Chief Development Officer, Oncology and Rare Disease, Pfizer Global Product Development. “We believe that elranatamab, if approved, has the potential to become the next standard of care for multiple myeloma given its favorable clinical results and convenient subcutaneous route of administration.”
The FDA is expected to make a decision on the application in 2023.
Pfizer’s elranatamab receives FDA and EMA filing acceptance. News release. Pfizer. Accessed February 22, 2023. https://www.pfizer.com/news/press-release/press-release-detail/pfizers-elranatamab-receives-fda-and-ema-filing-acceptance.
This article originally appeared on MPR