Pfizer’s Elrexfio granted EC approval for relapsed and refractory multiple myeloma

2023-12-11

免疫疗法临床结果上市批准临床2期

$Pfizer’s Elrexfio granted EC approval for relapsed and refractory multiple myeloma$

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来源: PMLiVE

Pfizer’s targeted immunotherapy Elrexfio (elranatamab) has been approved by the European Commission (EC) to treat adults with relapsed and refractory multiple myeloma.

The conditional marketing authorisation specifically applies to patients who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy.

More than 50,000 cases of multiple myeloma, an aggressive and currently incurable blood cancer, are diagnosed each year in Europe.

While the course of the disease varies, relapses are nearly inevitable, and most patients will receive four or more lines of therapy due to relapse.

Pfizer’s Elrexfio is an off-the-shelf, bispecific antibody designed to bind to BCMA, which is highly expressed on the surface of multiple myeloma cells, and CD3 receptors found on the surface of T-cells, bridging them together and activating the T-cells to kill the myeloma cells.

The EC’s decision on the treatment was supported by data from a subgroup of patients in the phase 2 MagnetisMM-3 trial who received Elrexfio as their first BCMA-directed therapy.

Patients in this cohort achieved an objective response rate of 61%, with a 71.5% probability of maintaining the response at 15 months.

Results from the study also established once-every-other-week dosing with Elrexfio for all responding patients after 24 weeks of weekly therapy, Pfizer said, with 80% of these patients maintaining or improving their response and 38% attaining a complete response or better after the switch.

Chris Boshoff, chief oncology research and development officer and executive vice president at Pfizer, said: "More than 50,000 Europeans are diagnosed with multiple myeloma each year, and too often, they face relapse and treatment resistance.

“[The] 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."

The announcement comes less than a month after Pfizer and Astellas’ Xtandi (enzalutamide) was approved by the US Food and Drug Administration to treat non-metastatic castration-sensitive prostate cancer (nmCSPC) patients with biochemical recurrence and a high risk of metastasis.