Pfizer's cancer drug elranatamab accepted for FDA and EMA review
Pfizer announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for its Biologics License Application (BLA) for elranatamab. The European Medicines Agency (EMA) has also accepted the marketing authorization application (MAA).
Pfizer Inc. announced that its investigational drug, elranatamab, has received acceptance for review by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The drug is being developed for patients with relapsed or refractory multiple myeloma (RRMM), a form of blood cancer.
The FDA has granted Priority Review for elranatamab's Biologics License Application (BLA), a designation intended to speed up the availability of drugs that may offer significant improvements over existing therapies. The agency's decision is anticipated in 2023. Concurrently, the EMA has accepted Pfizer's marketing authorization application (MAA) for the drug.
Elranatamab is a bispecific antibody designed to target BCMA, which is highly expressed on multiple myeloma cells, and CD3 receptors on T-cells. This mechanism aims to bridge T-cells to myeloma cells, activating the T-cells to kill the cancer cells. The submissions are primarily based on data from the MagnetisMM-3 trial.
Results from the MagnetisMM-3 study, involving heavily pretreated patients, showed an objective response rate of 61% with elranatamab monotherapy. The safety profile was manageable, with a specific dosing regimen designed to mitigate risks like cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). Pfizer is continuing research into elranatamab through its MagnetisMM clinical program.