Key Takeaways:
Johnson & Johnson's Tecvayli combo cut the risk of disease progression or death by 83.4% in a pivotal trial, earning a CHMP recommendation for earlier use.
The European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of Tecvayli (teclistamab) in combination with Darzalex SC (daratumumab subcutaneous) for adults with relapsed or refractory multiple myeloma who have received at least one prior therapy, J&J said June 29. The CHMP opinion is based on data from the Phase III MajesTEC-3 study, which evaluated the regimen against the investigator's choice of Darzalex SC and dexamethasone with either pomalidomide or bortezomib.
At nearly three years of follow-up, the Tecvayli-Darzalex SC combination demonstrated an 83.3% overall survival rate versus 65% for the standard of care. The safety profile was consistent with the known profiles of each drug individually, the company said. The hazard ratio of 0.166 for progression or death means patients on the combo had an 83.4% lower risk of disease progression or death compared with the control arm.
A positive European Commission decision typically follows the CHMP recommendation within one to two months. If approved, the regimen would become available as early as second-line treatment, expanding the addressable patient population beyond the current EU approval, which limits Tecvayli to patients who have received at least three prior therapies including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.
Tecvayli generated $202 million in first-quarter sales, up 33.5% year over year, driven by launch uptake and the recent US approval of the Darzalex Faspro combination for earlier-line treatment. The FDA approved that regimen in March 2026 for adults with RRMM who have received at least one prior line of therapy. J&J also submitted a type II variation application to the EMA in March 2026 seeking approval of Tecvayli as a monotherapy for RRMM after at least one prior therapy.
The expanded EU label would strengthen J&J's competitive position in the multiple myeloma market, where it faces Bristol Myers Squibb's Breyanzi and Sanofi's Sarclisa. J&J shares hit a 52-week high of $255.11 on June 26 and have gained 24.4% year to date, outpacing the healthcare industry's 13.1% advance. Investors will watch for the European Commission's final decision, expected within two months, and for continued uptake of the Tecvayli-Darzalex combination as J&J targets $100 billion in total revenue for 2026.
This article is for informational purposes only and does not constitute investment advice.
