With FDA approval for Elrexfio, Pfizer brings multiple myeloma battle to Johnson & Johnson

Another off-the-shelf, BCMA-directed drug has arrived for the treatment of multiple myeloma.

Monday, the FDA approved Pfizer’s Elrexfio, or elranatamab, for patients with multiple myeloma who've tried at least four prior lines of therapy.

Elrexfio will go toe to toe with Johnson & Johnson’s Tecvayli. Both drugs are bispecific antibodies that engage T cells to target BCMA-expressing cancer cells, and both are delivered under the skin. So far, the two therapies’ efficacy data are largely similar, while Elrexfio appears to boast a convenience edge—for now.

Pfizer will make Elrexfio available in the following weeks, a Pfizer spokesperson told Fierce Pharma. The drug bears an average monthly list price of $41,500, and a treatment course could cost around $330,000 based on the duration of treatment observed in a clinical trial, the spokesperson said. By comparison, J&J priced Tecvayli initially at $39,500 per month.

Elrexfio’s label shows that the Pfizer drug shrank tumors in 58% of patients who had received at least four lines of therapy prior to enrollment in cohort A of the phase 2 MagnetisMM-3 study. Updated data in June linked the drug to a 61% objective response rate, including 35% of patients who experienced a compete response or better. None of the patients had tried a BCMA-directed therapy before the study.

In J&J’s MajesTEC-1 trial, meanwhile, Tecvayli delivered an overall response rate of 63%, with 45% of patients experiencing complete responses or better, according to longer-term follow-up data shared in June. But the Tecvayli results came from a group that also included patients who had tried three prior lines of therapy.

In the BCMA bispecific rivalry, Pfizer is banking on Elrexfio’s ability to be dosed every other week following 24 weeks of weekly treatment. For now, J&J’s Tecvayli is given weekly during the maintenance phase. But J&J has submitted new data in hopes of turning Tecvayli into a biweekly treatment as well.

Among responders who switched to biweekly Tecvayli treatment in the MajesTEC-1 study—most of whom initially had a complete response—68.7% remained in response for at least two years from the time of first response, according to data released in June.

Drug profiles aside, between the two companies, J&J has more clout in multiple myeloma. J&J’s Darzalex is the leading CD38 antibody that’s approved as a front-line myeloma treatment. J&J’s Legend-partnered BCMA CAR-T drug Carvykti has yielded impressive efficacy data, recently showing it can reduce the risk of tumor progression or death by 74% over standard of care in the second- to fourth-line setting.

And J&J has just won FDA approval for Talvey, its first-in-class bispecific antibody that targets GPRC5D. The drug has shown strong tumor shrinkage ability in patients irrespective of prior exposure to BCMA-targeted agents, and it can be dosed biweekly.

By comparison, Elrexfio is Pfizer’s lone myeloma product. Seagen, which Pfizer is acquiring in a $43 billion deal, also has a BCMA-directed antibody dubbed SEA-BCMA. But the candidate recently disappeared from Seagen’s clinical development pipeline.

With Monday’s accelerated approval, Pfizer is still on the hook to prove Elrexfio’s benefits. The phase 3 MagnetisMM-5 trial will gather confirmatory evidence for Elrexfio in patients who had tried two classes of medicines, including Bristol Myers Squibb’s immune modulator Revlimid and a proteasome inhibitor such as Takeda’s Velcade. Pfizer is also running the MagnetisMM-7 study with Elrexfio as maintenance treatment in newly diagnosed patients after transplant.

Like Tecvayli, Elrexfio is available through an FDA-mandated safety program because of the risk of cytokine release syndrome (CRS) and neurotoxicity. In Tecvayli’s clinical trial, CRS occurred in 72% of patients—including 0.6% at grade 3—who received the drug at the recommended dose. In Elrexfio’s trial, the rate of grade 3 CRS was 2.3%, according to an update in June.