Key Points

  • 1. Pfizer's BCMA-CD3-targeted bispecific antibody, Elrexfio, has received conditional marketing authorization in the EU for the treatment of relapsed/refractory multiple myeloma.
  • 2. The approval is based on data from the phase II MagnetisMM-3 study, showing significant responses in heavily pre-treated patients.
  • 3. Elrexfio provides deep and long-lasting responses, with a manageable tolerability profile and convenient dosing.
  • 4. The approval represents a significant milestone for Pfizer and offers a new treatment option for patients in the European Union.
  • 5. Pfizer will continue to explore the potential of Elrexfio in earlier lines of treatment for multiple myeloma.

Pfizer Inc. (PFE) has marked a significant milestone in its fight against relapsed/refractory multiple myeloma (RRMM) as the European Commission (EC) has granted conditional marketing authorization for its BCMA-CD3-targeted bispecific antibody, Elrexfio (elranatamab), within the European Union (EU).

Promising Therapy

This promising therapy is specifically greenlit for heavily pre-treated patients who have undergone at least three prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and have encountered disease progression on their last therapy.

The EC’s favorable decision was rooted in compelling data from cohort A of the phase II MagnetisMM-3 study, which showcased substantive and meaningful responses among this particular patient subset. The anticipation for this approval was set in motion back in October when the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended the conditional marketing authorization for Elrexfio.

This commendable development demonstrates a leap forward in addressing the complexities of RRMM, a condition posing significant treatment challenges. Elrexfio, an off-the-shelf fixed-dose subcutaneous BCMA-CD3-targeted immunotherapy, stands out for its ability to deliver profound and enduring responses while maintaining a manageable tolerability profile, all with the added convenience of a streamlined dosing regimen.

While this accomplishment marks a noteworthy advancement in Europe, Pfizer continues to navigate the regulatory landscape in other regions. In the United States, the Food and Drug Administration (FDA) had granted accelerated approval to Elrexfio for the treatment of RRMM in August. However, it's important to note that the drug's label in the United States comes with a boxed warning concerning potential cytokine release syndrome and neurologic toxicity.

The Journey of Elrexfio

The journey of Elrexfio doesn't stop here. The MagnetisMM program persists in exploring the drug's potential for expanded utilization across different stages of myeloma treatment. This ongoing investigation spans the gamut from newly diagnosed multiple myeloma to RRMM, exploring Elrexfio's efficacy both as a standalone therapy and as part of combination regimens.

While this approval underscores progress in the treatment landscape for RRMM, Pfizer has faced a challenging market year, with shares declining by 43.8% compared to the industry's modest increase of 4.3%. Despite these market challenges, the conditional approval of Elrexfio in the EU paves the way for advancing treatment options in the battle against this complex hematologic condition.

Please note: This article is for informational purposes only and should not be considered as medical advice. Always consult with a healthcare professional for any medical guidance or treatment decisions.



About PFIZER INC


  • Ticker PFE
  • Exchange NYSE
  • Sector Healthcare
  • Industry Drug Manufacturers—General
  • Shares Outstandng 5,612,349,952
  • Market Cap $146B
  • Description
  • Pfizer Inc. discovers, develops, manufactures, markets, distributes, and sells biopharmaceutical products worldwide. It offers medicines and vaccines in various therapeutic areas, including cardiovascular metabolic and women's health under the Premarin family and Eliquis brands; biologics, small molecules, immunotherapies, and biosimilars under ...
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