New Drug Receives FDA Approval for Treatment of Relapsed or Refractory Multiple Myeloma

By Dustin Samples - February 28, 2023

In October 2022, the United States Food and Drug Administration (FDA) approved the use of TECVAYLI™ (teclistamab-cqyv) for the treatment of multiple myeloma (MM) in patients who previously received 4 or more treatments that included a proteasome inhibitor, immunomodulatory drug, and anti-CD38 monoclonal antibody.

Dr. Ajai Chari, Professor of Medicine, Division of Hematology and Medical Oncology at the Icahn School of Medicine at Mount Sinai, lauded the drug, stating, “The approval of teclistamab, as the first bispecific antibody in relapsed or refractory multiple myeloma, is a meaningful step in helping many…hard-to-treat patients.”

TECVAYLI™ works by “binding to the CD3 receptor expressed on the surface of T-cells and to the B-cell maturation antigen (BCMA) expressed on the surface of multiple myeloma cells and some healthy B-lineage cells,” as described in an October 25 press release by makers of the pharmaceutical, Johnson & Johnson.

The drug received accelerated approval, meaning additional trials and a “description of clinical benefits” may be required for continuous approval.

Nevertheless, the conditional approval is hopeful news for patients with MM who have experienced multiple disease relapses.

“The approval of TECVAYLI, which demonstrated an overall response rate of more than 60 percent in heavily pretreated patients, underscores our commitment to translate science into medicines as we strive toward our goal of one day eliminating this disease,” states Dr. Peter Lebowitz, Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC.

Johnson & Johnson’s press release includes additional details about the clinical trial that led to approval as well as information about side effects and adverse reactions.


U.S. FDA approves TECVAYLI™ (teclistamab-cqyv), the first bispecific T-cell engager antibody for the treatment of patients with relapsed or refractory multiple myeloma.

Post Tags:Multiple Myeloma Awareness