The EC approval was based on findings from cohort A of the Phase 2 MagnetisMM-3 study in which it showed meaningful responses among heavily pre-treated RRMM patients
Pfizer’s logo in the company’s headquarter. (Credit: Pfizer Inc.)
Pfizer has received conditional marketing authorisation from the European Commission (EC) for Elrexfio (elranatamab) to treat relapsed and refractory multiple myeloma (RRMM).
Elrexfio is an off-the-shelf, fixed-dose subcutaneously administered bispecific antibody (BsAb) immunotherapy directed at B-cell maturation antigen (BCMA)-CD3.
EC has approved the immunotherapy for RRMM patients who were previously administered with at least three therapies and have shown disease progression on the last therapy.
The authorisation comes after the recommendation of the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) for conditional marketing authorisation in October this year.
The EC approval was based on findings from cohort A of the Phase 2 MagnetisMM-3 study that showed meaningful responses among heavily pre-treated RRMM patients who were administered Elrexfio as their first BCMA-directed therapy.
As per the analysis of these patients, the objective response rate was noted at 61% with a 71% probability of maintaining response at 15 months.
The once-every-other-week dosing with the therapy showed long-term treatment tolerability.
In addition, 80% of the respondents who switched to every-other-week dosing at least six months before the data cut-off date maintained or enhanced their response after the switch.
Furthermore, 38% of responding patients attained a complete response (CR) or better after the switch.
Pfizer executive vice president and chief oncology research and development officer Chris Boshoff said: “More than 50,000 Europeans are diagnosed with multiple myeloma each year, and too often, they face relapse and treatment resistance.
“Today’s approval provides a new, broadly available option for people with hard-to-treat multiple myeloma, and we continue to explore the use of ELREXFIO in earlier lines of treatment so that more people may ultimately benefit from this therapy.”
In a separate development, the American pharmaceutical major announced the results from the late-stage BASIS clinical study assessing Marstacimab to treat people with severe haemophilia A and moderately severe to severe haemophilia B.
The results demonstrated a statistically significant and clinically meaningful effect on annualised bleeding rate (ABR).
It lowered ABR by 35% and 92% compared to routine prophylaxis and on-demand treatment in patients with haemophilia A and B without inhibitors, respectively.