FDA Approves Pfizer's Blood Cancer Therapy For Heavily Pretreated Patients

The FDA granted accelerated approval to Pfizer Inc's PFE Elrexfio (elranatamab-bcmm) for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior lines of therapy. 

Approval was based on the single-arm Phase 2 MagnetisMM-3 trial results, and continued approval for this indication is contingent upon verification of clinical benefit in a confirmatory trial(s). 

Elrexfio is a subcutaneously delivered B-cell maturation antigen (BCMA)-CD3-directed bispecific antibody (BsAb) immunotherapy that binds to BCMA on myeloma cells and CD3 on T-cells, bringing them together and activating the T-cells to kill myeloma cells.

Elrexfio will be sold in the U.S. at a list price of $7,556 and $13,051 for the 44 mg and the 76 mg vial, respectively, Reuters reported, citing the company.

The list price of the therapy is expected to be $41,500 per month, the company said, adding that it expects the monthly price to be lower at about $26,000 as patients move to bi-weekly dosing.

Pfizer has said the therapy could have more than $4 billion in potential peak revenue.

Elrexfio's label contains a Boxed Warning for cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome, warnings, and precautions for infections, neutropenia, hepatotoxicity, and embryo-fetal toxicity. 

Price Action: PFE shares are down 0.42% at $35.92 during the premarket session on the last check Tuesday.