Elrexfio Becomes Pfizer’s First Approved Multiple Myeloma Drug

After Johnson & Johnson’s US Food and Drug Administration (FDA) approval last week for its second multiple myeloma bispecific, Talvey (talquetamab), Pfizer received an FDA nod for its B-cell maturation antigen (BCMA)-directed therapy Elrexfio (elranatamab) in the same indication. Elrexfio is Pfizer’s first approved multiple myeloma drug.

However, Elrexfio will be going up head-to-head against Johnson & Johnson’s BCMA-targeted therapy Tecvayli (teclistamab). Both are bispecific antibodies, administered as subcutaneous infusions, that directly engage CD3+ T cells to target cancer cells that express BCMA.

The FDA granted accelerated approval to Elrexfio as a fifth-line therapy for adult patients with relapsed or refractory multiple myeloma.

Elrexfio may have the edge over Tecvayli as it can be administered once every other week after 24 weeks of weekly treatment compared to Tecvayli’s weekly dosing regimen. Pfizer said this means less time at the clinic and potentially greater long-term treatment tolerability. Johnson & Johnson has turned in new data to support its case for also making Tecvayli a biweekly treatment.

Multiple myeloma is an aggressive blood cancer that affects plasma cells, which make antibodies that help the immune system fight infections. It is the second most common type of blood cancer, with over 35,000 new cases diagnosed every year in the US and 176,000 globally.

Related: Talvey Becomes J&J’s Second Multiple Myeloma Bispecific to Score FDA Approval

The five-year survival rate of multiple myeloma is around 50 percent, and most patients will receive four or more lines of therapy due to relapse and therapy resistance. The three main classes of treatment are proteasome inhibitors, immunomodulatory agents and anti-CD38 monoclonal antibodies.

Elrexfio’s FDA approval was based on results from the Phase II MagnetisMM-3 trial. Pfizer said its continued approval will depend on verifying clinical benefit in a confirmatory trial(s).

Data from the MagnetisMM-3 trial showed meaningful responses among patients with relapsed or refractory multiple myeloma who received Elrexfio as their first BCMA-directed therapy and who received four or more lines of therapy prior to it. The overall response rate (percentage of patients who had tumor shrinkage) was 58 percent, with an estimated 82 percent that had a sustained response for at least nine months. The median time to first response was 1.2 months.

Among 63 patients who received Elrexfio biweekly following 24 weeks of weekly treatment, the overall response rate was 33 percent after a median follow-up of 10.2 months. Around 84 percent of responders maintained response for at least nine months.

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Elrexfio’s label contains a boxed warning for cytokine release syndrome (CRS) and neurologic toxicity (NT). Given this, it will be made available through an FDA administered safety program.

While Elrexfio is Pfizer’s first approval in multiple myeloma, Johnson & Johnson leads in the space with several FDA-approved therapies: Tecvayli, Legend Biotech-partnered CAR T-cell therapy Carvykti (ciltacabtagene autoleucel), CD38 antibody Darzalex (daratumumab), which is the leading CD38 antibody approved as a front-line myeloma treatment, and the recently approved Talvey.

Carvykti’s latest efficacy data is quite impressive, showing that it can cut the risk of tumor progression or death by 74 percent compared to standard of care as a second- to fourth-line treatment.

Pfizer said Elrexfio will be available in the coming weeks. The average monthly list price of Elrexfio is $41,500 and a full treatment regimen could be around $330,000 based on the duration of treatment as per its clinical trial. In comparison, Johnson & Johnson’s Tecvayli had an initial list price of $39,500 per month.