FOR IMMEDIATE RELEASE:
ELREXFIO™ (elranatamab-bcmm), Now Available from Onco360, Has Received FDA-Accelerated Approval for the Treatment of Adult Patients With Relapsed or Refractory Multiple Myeloma Who Have Received at Least Four Prior Lines of Therapy Including a Proteasome Inhibitor, an Immunomodulatory agent, and an anti-CD38 Monoclonal Antibody.
Louisville, KY — August 16, 2023 — Onco360®, the nation’s leading independent Specialty Pharmacy, has been selected as a trusted pharmacy for ELREXFIO™ (elranatamab-bcmm). ELREXFIO is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).1
“We are committed to providing a world class experience for patients and their caregivers through our team of experienced board-certified oncology pharmacists and oncology-certified nurses who understand the highly specialized needs of patients battling heavily-pretreated multiple myeloma across the United States,” said Benito Fernandez, Chief Commercial Officer.
Multiple myeloma is an incurable hematological malignancy involving the plasma cells which may lead to bone destruction and marrow failure.2 Based on the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) Program, an estimated 35,730 people in the United States will be diagnosed with multiple myeloma in 2023 while an estimated 12,590 people will die from the disease in 2023. Multiple myeloma, a rare malignancy, accounts for 1.8% of all new cancer cases in the United States. The median age at initial multiple myeloma diagnosis is 69 years old. The five-year overall survival (OS) for patients with multiple myeloma is 59.8%.3
ELREXFIO is commercialized by Pfizer. The United States Food and Drug Administration’s (US FDA) accelerated approval for ELREXFIO comes as a result of the Phase II MagnetisMM-3 clinical trial (NCT04649359). The MagnetisMM-3 clinical trial was an open-label, single arm, multi-center study which included patients who were refractory to at least one proteasome inhibitor (PI), one immunomodulatory agent (IMiD), and one anti-CD38 monoclonal antibody. The MagnetisMM-3 trial included 123 patients naïve to prior BCMA-directed therapy (pivotal Cohort A) and 64 patients with prior BCMA-directed antibody drug conjugate (ADC) or chimeric antigen receptor (CAR) T-cell therapy (supportive Cohort B). Among the 97 patients in the efficacy population, ELREXFIO administration resulted in a 57.7% objective response rate (ORR). ELREXFIO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) program called the ELREXFIO REMS program. The goal of the ELREXFIO REMS program is to mitigate the risks of Cytokine Release Syndrome (CRS) and neurologic toxicity including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) by ensuring prescribers are aware of the importance of monitoring for signs and symptoms of CRS and neurologic toxicity including ICANS in patients exposed to ELREXFIO.1,4
For full prescribing information, please visit: ELREXFIO Prescribing Information
For full information regarding the ELREXFIO REMS program, please visit www.elrexfiorems.com
- ELREXFIO™ Prescribing Information. Accessed August 19, 2023 pfizer.com/ShowLabeling.aspx?id=19669
- National Comprehensive Cancer Network (NCCN) Guidelines for the Treatment of Multiple Myeloma. Accessed August 19, 2023. myeloma.pdf (nccn.org)
- National Cancer Institute Surveillance, Epidemiology, and End Results Program. Accessed August 19th, 2023. Myeloma — Cancer Stat Facts
- ELREXFIO REMS Program. Accessed 8/19/23. ELREXFIOREMS.com
Pfizer, ELREXFIO™ and associated logos are registered trademarks of Pfizer, Inc.