FDA approves Janssen’s TECVAYLI for multiple myeloma treatment

The Janssen Pharmaceutical Companies, a subsidiary of Johnson & Johnson, announced the US Food and Drug Administration’s approval of its first bispecific T-cell engager antibody, TECVAYLI (teclistamab-cqyv). The medication is intended for the treatment of relapsed or refractory multiple myeloma patients.

TECVAYLI is indicated for patients previously treated with a proteasome inhibitor, immunomodulatory drug, and anti-CD38 monoclonal antibody. Administered subcutaneously, TECVAYLI, a pioneering bi-specific T-cell engager antibody, is ready to use. It functions by activating the immune system, attaching to the CD3 receptor found on T-cell surfaces and the B-cell maturation antigen expressed on multiple myeloma cells and some healthy B-lineage cells.

The FDA granted TECVAYLI accelerated approval based on the response rate, with continued approval contingent on the demonstration of clinical benefits in confirmatory trials. TECVAYLI is Janssen’s fourth FDA-approved treatment for multiple myeloma, expanding its oncology portfolio dedicated to developing solutions for this rare blood cancer.

“We are greatly encouraged by the FDA’s approval of teclistamab and Janssen’s commitment to the multiple myeloma community,” said Michael Andreini, President and CEO of the Multiple Myeloma Research Foundation. “Teclistamab is an important new treatment option for patients who have faced multiple relapses.”

Peter Lebowitz, Global Therapeutic Area Head, Oncology, Janssen Research & Development, expressed the company’s resolve to discover and develop critical cancer treatments. He noted TECVAYLI’s approval, with its overall response rate of over 60 percent in heavily pretreated patients, reinforces their commitment to turning science into effective medications.

The Phase 2 MajesTEC-1 clinical trial, which led to the approval, showed positive results in heavily pretreated patients. The trial included patients who had received a median of five prior lines of therapy and showed an average response rate of 61.8 percent. Impressively, 28.2 percent of patients achieved a full response or better. The median time to the initial response was 1.2 months, and with a median follow-up of 7.4 months, the estimated time of response rate was 90.6 percent at six months and 66.5 percent at nine months.

Ajai Chari, Professor of Medicine, Division of Hematology and Medical Oncology at the Icahn School of Medicine at Mount Sinai and a study investigator, hailed the approval of TECVAYLI as a significant step in assisting many hard-to-treat patients.