Pfizer’s BCMAxCD3 Bispecific Antibody Elranatamab Receives FDA Breakthrough Therapy Designation for Relapsed or Refractory Multiple Myeloma

News on November 5, 2022 /BioValleyBIOON/ --- Pfizer recently announced that the U.S. Food and DrugManagementBureau (FDA) has been grantedBCMAxCD3 Bispecific Antibody (BsAb) Elranatamab (PF-06863135)Breakthrough Therapy Designation (BTD):For the treatment of patients with relapsed or refractory multiple myeloma (RRMM).

BTD is a new drug review channel created by the FDA in 2012. It aims to accelerate the development and review of new drugs for the treatment of serious or life-threatening diseases, with preliminary clinical evidence indicating that they can substantially improve the condition compared to existing treatments. Drugs granted BTD receive closer guidance during development, including from high-level FDA officials, and are eligible for rolling review and potential priority review to ensure new treatment options are provided to patients in the shortest possible time.

Bispecific Antibody (BsAb) is a novel type of cancerImmunityA therapy that can simultaneously bind to two different targets, with one arm directly binding to a specific antigen on cancer cells, and the other arm activating T cells in the patient's own immune system, bringing them close to the cancer cells to kill them.

Elranatamab is designed to bind to B-cell maturation antigen (BCMA), which is highly expressed on the surface of multiple myeloma cells, and the CD3 receptor on T cells, bridging them together to activate T cells to kill myeloma cells.Elranatamab’s binding affinity for BCMA and CD3 has been optimized to elicit potent T-cell-mediated anti-myeloma activity. Elranatamab is administered via subcutaneous injection, which is more convenient than intravenous infusion and may reduce the risk of potential adverse events, such as cytokine release syndrome (CRS).

Effective Biotherapeutic Targets on the Surface of Multiple Myeloma Cells (Image Source: PMID:30545798)

In addition to BTD, elranatamab has also been granted Orphan Drug Designation (ODD) by the U.S. FDA and the European Medicines Agency (EMA) for the treatment of multiple myeloma (MM). The FDA and EMA have also separately granted elranatamab Fast Track Designation (FTD) and Priority Medicines (PRIME) designation for the treatment of RRMM.

FDA Grants Elranatamab BTD Based on 6-Month Follow-Up Data from Cohort A (n=123) of the MagnetisMM-3 Study. This is an open-label, multicenter, single-arm, Phase 2 study evaluating the safety and efficacy of elranatamab monotherapy in patients with RRMM. In the study, patients received subcutaneous (SC) elranatamab 76mg once weekly (QW), with a two-step priming dose regimen administered in the first week.

Results ShowElranatamab demonstrated a manageable safety profile, with an overall response rate (ORR) of 61.0% at a median follow-up of 6.8 months. Among patients who achieved a response, the probability of maintaining the response for ≥6 months was 90.4%.Regardless of causality, the most common treatment-emergent adverse events (TEAEs) were CRS (57.9%), with the majority of reported events being Grade 1 (43.2%) or Grade 2 (14.2%). (Bioon.com)

Source of Original Text:Pfizer’s Elranatamab Granted FDA Breakthrough Therapy Designation for Relapsed or Refractory Multiple Myeloma