J&J's Tecvayli wins CHMP nod for expanded multiple myeloma use

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Johnson & Johnson announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval for the expanded use of Tecvayli in multiple myeloma. The CHMP recommended Tecvayli in combination with the Darzalex subcutaneous formulation for adults with relapsed or refractory multiple myeloma who have received at least one prior therapy. The recommendation was based on the phase III MajesTEC-3 study, which showed the combination reduced the risk of disease progression or death by 83.4% versus the standard of care, with overall survival of 83.3% at three years compared to 65% for the standard of care. Tecvayli is already approved in Europe for patients who have received at least three prior therapies, and J&J submitted a separate application in March 2026 for monotherapy use after at least one prior therapy. In the United States, Tecvayli is approved both as monotherapy in heavily pretreated patients and in combination therapy for earlier treatment lines, with the combination approval granted in March 2026. The drug recorded sales of $202 million in the first quarter of 2026, up 33.5% year over year.

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Biotech & Genomic Medicine · 3 stocks
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CHMP recommendation for expanded use of Tecvayli in multiple myeloma, based on strong efficacy data, likely to increase sales.

Health Care · 1 stocks

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