Elranatamab Receives FDA Accelerated Approval for Refractory/Relapsed Myeloma Treatment

Pfizer announced on Monday, August 14th that their new bi-specific antibody, elranatamab, had been granted accelerated approval from the U.S. Food and Drug Administration (FDA) to treat relapsed and refractory multiple myeloma patients. Elranatamab is commercially known as ELREXFIO.

The approval of ELREXFIO, which targets the BCMA protein found on the surface of myeloma cells, is for myeloma patients that have received at least four prior lines of therapy, including a proteasome inhibitor (such as VELCADE), an immunomodulatory agent (such as REVLIMID), and an anti-CD38 monoclonal antibody (such as DARZALEX).

This approval is incredible news for the multiple myeloma community, who are now allowed more options for treatment than ever before. The recent approval of talquetamab, another bi-specific targeting GPRC5D, occurred last week, adding to the ever-growing and effective arsenal for myeloma patients. 

The recent push of immunotherapy treatments for multiple myeloma is especially exciting, as these medications are tending to show improvements in quality of life (although there remains a risk of immune system reactions and infections) and impressive efficacies. 

In fact, the Phase 2 MagnetisMM-3 study showed meaningful reactions even in heavily pre-treated patients who received elranatamab as their first BCMA-directed therapy. In this cohort of patients, the overall response rate was 58%, with an estimated 82% maintaining the response for at least nine months.

However, in the arm of patients that had previously received BCMA-directed therapy, responses were lower. The overall response rate (ORR) was 33% after a median follow-up of 10.2 months, with an estimated 84% maintaining the response for at least nine months.

Although the myeloma patients taking elranatamab will receive weekly therapy for 24 weeks, they have the option to change their dosages to once every other week until progression. This allows patients to spend less time in the clinic, giving them more time to focus on their quality of life. 

Elranatamab, like all multiple myeloma medications, has possible side effects. These include cytokine release syndrome (CRS) and neurologic toxicity (NT), including immune effector cell-associated neurotoxicity syndrome (ICANS), in addition to infections, neutropenia (low blood counts), hepatotoxicity (damage to the liver caused by medication or supplement) and embryo-fetal toxicity (if taken while pregnant). While these are not guaranteed side effects for every user of ELREXFIO, they are something to be aware of. 

As a precaution due to the risks of CRS and ICANS, patients should be hospitalized for 48 hours following the first step-up dose and for 24 hours following the second step-up dose. No hospitalization is required for the third step-up dose. Also given the risk of CRS and NT, including ICANS, ELREXFIO is available only through a restricted program called the ELREXFIO Risk Evaluation and Mitigation Strategy (REMS), similar to other myeloma medications. Your safety matters! 

Our HealthTree Foundation Founder, Jenny Ahlstrom, comments on the exciting approval. 

“Accessibility is key to unlocking the potential impact of new treatment options. Unfortunately, novel therapies for triple-class-exposed multiple myeloma can be out of reach for medically underserved populations,” Jenny said. “With the approval of ELREXFIO, patients have a new off-the-shelf treatment option that can be delivered on an ongoing basis in community clinics, where the majority of patients with multiple myeloma receive their care.”

It's certainly exciting news for physicians and patients alike in the myeloma community. 

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Curious about other approvals and myeloma advances? Read here: New in Myeloma Articles 

Talquetamab was also approved this week. Learn more here: FDA Approval for Talquetamab