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The agency recommended conditional marketing authorization for Elrexfio (elranatamab) as a monotherapy for adult patients with relapsed and refractory multiple myeloma.
The European Medicines Agency (EMA) announced on Oct. 13, 2023 that the agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended a conditional marketing authorization for Elrexfio (elranatamab) as a monotherapy for patients “withrelapsed and refractory multiple myeloma who have received at least three prior therapies and whose cancer has worsened since they received their last treatment.” The treatment was supported by the agency’s PRIority Medicines (PRIME) scheme, which fosters medicines that target unmet needs.
Elranatamab is a monoclonal antibody (mAb) that simultaneously targets B-cell maturation antigen (BCMA), which is present on the surface of the multiple myeloma cells, and to CD3, a protein that is present on the T cells (cells in the immune system). The mAb activates T cells to kill the multiple myeloma cells.
The recommendation was based on an open-label, single arm, multicenter, Phase II clinical trial that investigated the treatment’s efficacy “in 123 participants with refractory multiple myeloma who had received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, but who had not received prior BCMA-directed therapy. 61% of patients enrolled in the trial responded to the treatment with Elrexfio and more than 70% of the responding patients have a probability to live without their disease getting worse for an average of 15 months,” EMA stated in a press release. The safety of the mAb was shown after data from 265 participants were analyzed. Common side effects included a decrease in blood cells, infections, and cytokine release syndrome (CRS). According to EMA, “One of the main risks associated with elranatamab use is neurological toxicity including immune effector cell-associated neurotoxicity (ICANS), as these events have the potential to be life-threatening or fatal if not properly managed. Monitoring and mitigation strategies for CRS and ICANS are described in the product information and in the risk management plan that is an integral part of the authorization.”
The maker of Elrexfio (elranatamab) will have to submit data from a randomized Phase III trial to confirm the results of previous studies. Submission of final results of the pivotal Phase II clinical trial will also need to occur.
CHMP’s recommendation will be sent to the European Commission for adoption in the European Union.