Catching up on recent approvals…..
Earlier this week we sent a Report on the approval of Talvey from Janssen Pharmaceuticals indicated for he treatment of adult patients with relapsed or refractory multiple myeloma. Within days the FDA issued approval for another subcutaneous therapy, Elrexfio (elranatamab-bcmm) from Pfizer, Inc. Talvey was a first-in-class bispecific antibody.
Like Talvey, Elrexfio is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
Similarly, approval of Elrexfio included a Black Box Warning for cytokine release syndrome (CRS) and neurologic toxicity including immune effector cell-associated neurotoxicity syndrome (ICANS). The assigned REMS program includes monitoring requirement for oral toxicity, weight loss, infections, cytopenias, skin toxicity, hepatoxicity and embryo-fetal toxicity. Seeing a trend here?
Approval requires that patients be hospitalized for 48 hours after all doses within the step-up dosing schedule. Another coincidence to be sure.
Pfizer did not disclose details for distribution or logistics at the time of approval.
The company did confirm that Elrexfio will launch at a cost of $41,500 per month (about $330,000 annually). This compares with Talvey’s launch price of $45,000 per month.
Given its cost, complex dosing schedule and multiple risks, Elrexfio will likely be handled through specialty pharmacy distribution.
