Janssen Scores Another Multiple Myeloma FDA Approval with Tecvayli

After the European Commission approved Janssen’s multiple myeloma treatment, Tecvayli, in August, the company received notice that the FDA approved the drug in the U.S. through the accelerated approval pathway as a late-line therapy on October 25. Tecvayli marks Janssen’s fourth FDA-approved treatment for multiple myeloma and the first bispecific T-cell treatment for the disease.

Tecvayli as the First Bispecific T-Cell Treatment for Multiple Myeloma

An incurable blood cancer affecting plasma cells in bone marrow, multiple myeloma is a devastating disease impacting tens of thousands of Americans yearly. Early treatment lines for multiple myeloma often include a proteasome inhibitor, an immunomodulator agent, and an anti-CD38 monoclonal antibody.

The FDA approved Tecvayli as a late-line therapy for multiple myeloma patients who underwent at least four lines of previous treatment. The drug could be a valuable asset for patients who have experienced multiple relapses after prior therapies. 

Tecvayli is a bispecific T-cell engager antibody administered subcutaneously. Janssen designed the therapy to activate the immune system by binding to the CD3 receptor on T-cells and to the B-cell maturation antigen (BCMA) on multiple myeloma cells’ surfaces and some healthy B-lineage cells.

Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head of Oncology at Janssen, said, “Today’s achievement, which marks an important addition to our diverse and growing oncology portfolio, strengthens our resolve to discover and develop much-needed cancer treatments for patients and physicians.”

The FDA approved Tecvayli based on data from the MajesTEC-1 study. The drug only underwent two clinical trial phases and may require confirmatory trials to gain regular approval or approval for other indications. 

Related Article: Johnson & Johnson’s Multiple Myeloma Treatment Wins Accelerated Approval

Achieving 61.8% ORR in Phase 2 Trials

The Phase 2 leg of the MajesTEC-1 study recruited 192 participants who received at least three lines of prior therapy for multiple myeloma. Janssen said that 78% received four or more lines of previous therapy, and all received a proteasome inhibitor, an immunomodulator agent, and an anti-CD38 monoclonal antibody. 

During the Phase 2 clinical trial, patients started with small Tecvayli doses of 0.3 mg/kg to 0.6 mg/kg before stepping up to the recommended 1.5 mg/kg. Participants received weekly treatments of the recommended dose or until disease progression or unacceptable toxicity. 

The study’s primary endpoints included overall response rate (ORR) or unacceptable toxicity, with secondary endpoints including duration of response, very good partial response, complete response, time to response, and many more. Tecvayli demonstrated an ORR of 61.8%, meeting the primary endpoint. For a secondary endpoint, Tecvayli demonstrated a 28.2% complete response rate, ticking another box for the drug.

Already a leader in the multiple myeloma space, Tecvayli’s accelerated approval plunges Janssen deeper into the area. The European approval marked a sign of good things to come for the drug, and now with the FDA’s stamp, Tecvayli is ready to hit the U.S. market and serve multiple myeloma patients with at least four lines of previous therapy. 

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Reed Slater