FDA Grants Accelerated Approval to Elrexfio for Multiple Myeloma

The FDA has granted accelerated approval to Pfizer’s Elrexfio (elranatamab-bcmm) to treat adult patients with relapsed or refractory multiple myeloma (RRMM). It is indicated for patients who have had at least four prior lines of therapy.

Multiple myeloma is an aggressive and currently incurable blood cancer that affects plasma cells made in the bone marrow, and more than 35,000 new cases of multiple myeloma are diagnosed annually in the United States.

Elrexfio is a subcutaneously delivered B-cell maturation antigen (BCMA)-CD3-directed bispecific antibody immunotherapy. It binds to BCMA on myeloma cells and CD3 on T-cells, bringing them together and activating the T-cells to kill myeloma cells. It is the first BCMA-directed therapy in the United States with the option for every-other-week dosing after 24 weeks of weekly treatment.

Elrexfio will be available within the next few weeks. It will have a list price of $7,556 for the 44 mg vial and $13,051 for the 76 mg vial, or a monthly price of $41,500, which a spokesperson said is similar to other approved multiple myeloma therapies. The company expects the monthly price to be lower (about $26,000) as patients move to bi-weekly dosing. 

Pfizer offers patients the support of Patient Access Navigators, through the Pfizer Oncology Together program, who provide personalized services for all aspects of treatment, including financial assistance resources, treatment support, and resources to navigate potential insurance and coverage issues.

Ajay K. Nooka, M.D.

“Most multiple myeloma patients will experience relapse or resistance of their disease to treatment, often facing increased symptom burden and lowering their chance of surviving longer with each attempted line of therapy,” Clinical Trial Investigator Ajay K. Nooka, M.D., MPH, director of the Multiple Myeloma Program at Winship Cancer Institute of Emory University, said in a press release.

The accelerated approval was based on the results of the single-arm phase 2 MagnetisMM-3 trial. Among the 97 patients in cohort A who received four or more lines of therapy prior to Elrexfio, the overall response rate was 58%, with an estimated 82% maintaining the response for at least nine months. The median time to first response was 1.2 months.

The label also includes data from the 64 patients in cohort B, which showed that the overall response rate was 33% after a median follow-up of 10.2 months, with an estimated 84% maintaining the response for at least nine months.

Longer-term efficacy data from cohort A were presented at the 2023 European Hematology Association meeting, which found that the objective response rate was 61%. For the responding patients, the probability of maintaining a response at 15 months was 72%. Among responding patients who switched to every-other-week dosing, 80% maintained or improved their response after the switch, with 38% attaining a complete response or better after the switch.

Elrexfio’s label contains a boxed warning for cytokine release syndrome and neurologic toxicity (NT), including immune effector cell-associated neurotoxicity syndrome, in addition to warnings and precautions for infections, neutropenia, hepatotoxicity and embryo-fetal toxicity.

A confirmatory trial (MagnetisMM-5) involving 854 patients began in 2022.

Related: FDA Approves Talvey to Treat Blood Cancer

This is the second multiple myeloma therapy to be approved in two weeks. Just last week, the FDA granted accelerated approval to Janssen’s Talvey (talquetamab-tgvs) to treat adult patients with relapsed or refractory multiple myeloma. It is also a bispecific monoclonal antibody, but it has a different target — GPRC5D, which is overexpressed on multiple myeloma cells. Talvey will have a price of $45,000 per month, for a range of $270,000 to $360,000, based on the average treatment duration of six to eight months.