BEERSE, Belgium, March 10, 2026, 18:42 (CET)
Johnson & Johnson on Tuesday said it’s filed with the European Medicines Agency to expand Tecvayli’s EU label, aiming to allow the therapy as a single agent for adults with relapsed or refractory multiple myeloma who’ve already had at least one prior treatment. That would move the drug up in the treatment sequence for the blood cancer, where, according to the company, patients still encounter some of the toughest care gaps. JNJ.com
The timing is notable: five days after U.S. regulators gave the nod to Tecvayli with Darzalex for certain patients who’ve had just one prior therapy, J&J gets a boost in myeloma markets on both sides of the Atlantic. This development arrives as the company pushes newer cancer therapies to counteract Stelara losses to biosimilars and keep its $100.5 billion 2026 sales target within reach. Reuters
Backing its EMA submission, Johnson & Johnson pointed to results from the phase 3 MajesTEC-9 trial, which included 614 participants. The company reported Tecvayli slashed the risk of disease progression or death by 71%, and lowered the risk of death by 40% compared to standard regimens in patients whose multiple myeloma had either relapsed or become refractory to earlier treatment. JNJ.com
Tecvayli holds conditional approval in Europe as a monotherapy for later treatment lines. Emory’s Roberto Mina called January’s topline data a turning point, saying the drug could become “an essential therapy” even at first relapse. J&J’s Jordan Schecter, for his part, said Tuesday’s submission targets more durable and deeper responses, brought forward in the disease. JNJ.com
U.S. regulators acted quickly, clearing Tecvayli combined with Darzalex just 55 days after review began. Luciano Costa, a trial investigator, described the combo as something that could “redefine how we approach” relapsed multiple myeloma—a plasma cell cancer affecting the white blood cells that produce antibodies. Reuters
The competitive landscape is starting to heat up. Pfizer’s Elrexfio is already on the market for late-line myeloma patients, while Bristol Myers Squibb reported Monday that its mezigdomide regimen hit the primary endpoint in a pivotal trial for relapsed myeloma. RBC’s Trung Huynh described the mezigdomide program as “modestly overlooked” before more detailed results come out. U.S. Food and Drug Administration
The franchise is already showing up in the results. Darzalex posted $14.35 billion in sales for 2025, a 23% jump, fueling J&J’s $94.2 billion full-year revenue haul as oncology continued to drive growth. Johnson Johnson Investor Relations
J&J stock edged up roughly 0.7% during early afternoon trading in New York on Tuesday.
Even so, Europe just has the filing on the table for now. The complete MajesTEC-9 data still hasn’t surfaced at any major medical conference. Safety questions linger: during the U.S. combo trial, investigators saw serious infections and cytokine release syndrome—essentially the immune system going into overdrive—as notable issues. The company, for its part, maintains that nothing unexpected turned up in the monotherapy arm. JNJ.com
