Johnson & Johnson Secures FDA Approval for Tecvayli and Darzalex Faspro Combo in Relapsed/Refractory Multiple Myeloma

on

Johnson & Johnson received FDA approval for Tecvayli combined with Darzalex Faspro for adult patients with relapsed or refractory multiple myeloma after at least one prior therapy including a proteasome inhibitor and immunomodulatory agent.1

This approval positions the regimen as a potential new standard of care as early as second-line treatment for about 40% of patients who relapse.1

Separately, on March 5, 2026, FDA approved Darzalex Faspro with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma patients ineligible for autologous stem cell transplant, marking its twelfth indication and fifth in newly diagnosed cases.23

The newly diagnosed approval is based on a trial of 395 patients showing higher minimal residual disease negativity rates compared to VRd alone.2

J&J's oncology sales grew 22.1% year-over-year to $25.38 billion, with Darzalex revenue up 95.9% to $1.89 billion.2

Sources:

1. https://www.gurufocus.com/news/8682594/johnson-johnson-jnj-gains-fda-approval-for-new-multiple-myeloma-treatment

2. https://stocktwits.com/news-articles/markets/equity/jnj-stock-rises-on-fresh-fda-approval-for-multiple-myeloma-drug/cmyOB6UR4id

3. https://www.marketscreener.com/news/johnson-johnson-s-janssen-biotech-unit-secures-us-fda-approval-for-multiple-myeloma-treatment-ce7e5fdbdc80f421