SMC Approves Pfizer’s Elrexfio for Relapsed and Refractory Multiple Myeloma

Pfizer’s innovative medication, Elrexfio (elranatamab), has recently gained approval from the Scottish Medicines Consortium (SMC) for use as a standalone treatment in adults suffering from relapsed and refractory multiple myeloma. This BCMA-targeting bispecific antibody will now be accessible through the NHS in Scotland temporarily for patients who have undergone at least three previous treatments, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have exhibited disease progression despite these therapies.

Multiple myeloma is a relentless cancer affecting about 475 individuals in Scotland annually. It originates in plasma cells, a type of white blood cell, and typically impacts various parts of the body. The disease follows a relapsing-remitting cycle, meaning it can return after periods of remission, necessitating further treatment.

Elrexfio, administered via subcutaneous injection, is intended to enhance the immune system's ability to detect and eliminate cancer cells. It achieves this by binding to both BCMA, which is abundantly present in multiple myeloma cells, and CD3 receptors on T cells. The SMC’s decision to provide interim access to Elrexfio was based on encouraging outcomes from the MagnetisMM-3 study, a mid-stage clinical trial.

Pfizer has disclosed detailed overall survival (OS) data from this trial, revealing a median OS of 24.6 months for patients in cohort A, who had not previously received BCMA-directed therapy. With more than two years of follow-up, the overall response rate for patients on Elrexfio was 61%, with the depth of responses improving over time, and the median duration of response not yet determined.

Ruhe Chowdhury, Pfizer UK's oncology medical director, expressed the company's satisfaction with the SMC's approval, stating, “We are delighted that the SMC has accepted Elrexfio for use within NHS Scotland.” He emphasized that this availability would provide timely access to a much-needed treatment for patients whose options are diminishing as their disease becomes resistant to successive therapies.

This approval follows closely on the heels of another significant milestone for Pfizer, as the European Commission recently granted conditional marketing authorization for their haemophilia B gene therapy, Durveqtix (fidanacogene elaparvovec), aimed at treating adults with severe and moderately severe forms of the rare bleeding disorder.