Business
Johnson & Johnson submits application to the European Medicines Agency for TECVAYLI®▼ (teclistamab) in combination with DARZALEX® (daratumumab) subcutaneous formulation for patients with relapsed/refractory multiple myeloma
Novel immunotherapy combination regimen brings together two complementary therapies to improve outcomes for people living with multiple myeloma as early as...
About this update from Johnson & Johnson
[{"type":"image","alt":"Janssen Cilag International NV","displaySize":"","headline":null,"caption":"Janssen Cilag International NV","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":57,"url":"https://media.zenfs.com/en/globenewswire.com/162e5e4bfb9f63ed2555dd2e00c88cf1"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/2MtQqo3wJMdkPmsB1cKplQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTgwO2NmPXdlYnA-/https://media.zenfs.com/en/globenewswire.com/162e5e4bfb9f63ed2555dd2e00c88cf1","width":300,"height":57}},"lazy":false},{"type":"text","content":"Novel immunotherapy combination regimen brings together two complementary therapies to improve outcomes for people living with multiple myeloma as early as second line1","length":168,"tagName":"p"},{"type":"text","content":"The application is supported by data from the Phase 3 MajesTEC-3 study demonstrating a statistically significant improvement in progression-free and overall survival compared to standard treatment1","length":197,"tagName":"p"},{"type":"text","content":"Beerse, Belgium, Jan. 06, 2026 (GLOBE NEWSWIRE) -- Johnson & Johnson today announced the submission of a Type II variation application to the European Medicines Agency (EMA) seeking approval for an indication extension of TECVAYLI®▼(teclistamab) in combination with DARZALEX® subcutaneous (daratumumab SC) formulation for the treatment of adult patients with relapsed/refractory multiple myeloma (RRMM) who have received at least one prior therapy.","length":453,"tagName":"p"},{"type":"text","content":"The combination of teclistamab and daratumumab SC work in a complementary manner by targeting both BCMA and CD38 to prime and activate the immune system, supporting the potential to improve patient outcomes by enhancing immune-mediated response earlier in the treatment journey.1","length":279,"tagName":"p"},{"type":"text","content":"“There remains a critical need for off-the-shelf treatment options that can achieve deep and durable responses at second line, when immune function is better preserved,” said Ester in ’t Groen, EMEA Therapeutic Area Head, Haematology, Johnson & Johnson Innovative Medicine. “Teclistamab and daratumumab SC is the first off-the-shelf immunotherapy combination to demonstrate significant improvements in progression-free and overall survival in relapsed/refractory multiple myeloma as early as seco...