Pfizer’s portfolio of medicines is expanding to multiple myeloma with FDA approval of a new drug that will compete head to head with a Johnson & Johnson product that addresses the same cancer target.
The Pfizer drug, elranatamab, is approved for treating advanced cases of multiple myeloma that have progressed after at least four earlier lines of therapy. The regulatory decision is an accelerated approval that will require Pfizer to confirm patient benefit with post-marketing testing. The pharmaceutical giant will commercialize its new subcutaneously administered drug under the brand name Elrexfio.
Elrexfio is a bispecific antibody engineered to bind to two targets. On T cells, it binds to a protein called CD38. On tumors, it binds to BCMA, a protein abundant on the surface of multiple myeloma cells. Binding to both targets brings the T cell and cancer cell together, activating the immune cell to kill the cancer cell.
FDA approval is based on results from a Phase 2 study that showed an overall response rate of 58%. Of those who responded to treatment, an estimated 82% maintained that response for at least nine months.
The approved indication for Elrexfio mirrors that of Tecvayli, a BCMA-targeting bispecific antibody from J&J that won its regulatory nod in multiple myeloma last year. After step-up dosing, Tecvayli is administered once weekly. Pfizer’s new drug comes with the advantage of less frequent dosing. After step-up dosing, Elrexfio is administered every other week.
Elrexfio’s label carries a black box warning that alerts patients and physicians that the drug may cause excessive immune responses and neurotoxicity, known complications that are also flagged on the labels of other cancer immunotherapies. Pfizer has additional clinical trials underway evaluating Elrexfio in earlier lines of treatment, both as a monotherapy and in combination with other drugs.
