The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended marketing authorization for Pfizer’s elranatamab in the treatment of relapsed or refractory (R/R) multiple myeloma (MM) in patients who have received at least three prior treatments, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody. Patients must also have demonstrated disease progression with their most recent therapy.
Elranatamab is a B-cell maturation antigen (BCMA)-directed immunotherapy administered subcutaneously that works by binding to BCMA on myeloma cells and CD3 on T cells, directing the T cells to kill myeloma cells. It’s available off the shelf.
CHMP support for the treatment was based on the results of cohort A of the phase II MagnetisMM-3 study, which showed an objective response rate of 61% at 15 months. Results also found once-every-other-week dosing to be efficacious in patients responding after 24 weeks of weekly dosing.
The treatment also received U.S. Food and Drug Administration accelerated approval in August.
“We discovered and developed [elranatamab] as an off-the-shelf (ready-to-use) fixed-dose option with a subcutaneous administration to be broadly accessible as quickly as possible,” said Chris Boshoff, chief oncology research and development officer and executive vice president of Pfizer. “We’re excited at the possibility of [elranatamab] reaching people with [MM who] have [R/R] disease across Europe. We’re also exploring the use of [elranatamab] in earlier lines of therapy to potentially help even more people with [MM].”
Source: Pfizer, October 13, 2023.
