Elranatamab receives breakthrough therapy designation for advanced multiple myeloma
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The FDA granted breakthrough therapy designation to elranatamab for treatment of relapsed or refractory multiple myeloma.
Elranatamab (Pfizer) is a B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody. The agent is designed to bind to BCMA — which is highly expressed on the surface of multiple myeloma cells — and the CD3 receptor found on the surface of T cells.
“The FDA’s breakthrough designation recognizes the potential of elranatamab as an innovative medicine for people with multiple myeloma whose disease has relapsed or is refractory to existing treatments, which at present leaves very few avenues for staving off this currently incurable cancer,” Chris Boshoff, MD, PhD, chief development officer for oncology and rare diseases at Pfizer, said in a company-issued press release.
The FDA based the breakthrough therapy designation on 6-month follow-up data from the phase 2 MagnetisMM-3 study, which evaluated the safety and efficacy of elranatamab monotherapy for patients with relapsed or refractory multiple myeloma.
Patients received subcutaneous elranatamab 76 mg weekly with a two-step-up priming dose regimen administered during the first week.
After median follow-up of 6.8 months, researchers reported a 61% overall response rate. The majority (90.4%) of responses lasted at least 6 months.
Elranatamab exhibited a manageable safety profile.
More than half (57.9%) of study participants experienced cytokine release syndrome, with most cases being grade 1 (43.2%) or grade 2 (14.2%).
Updated data from MagnetisMM-3 will be presented at this year’s ASH Annual Meeting and Exposition, scheduled for Dec. 10-13 in New Orleans.
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