Healthcare
CHMP recommendation advances Johnson & Johnson’s TECVAYLI®▼ (teclistamab) plus daratumumab as a potential standard of care for relapsed/refractory multiple myeloma
Recommendation supported by unprecedented Phase 3 data, demonstrating that TECVAYLI® in combination with daratumumab achieved statistically significant improvements in progression-free and overall survival versus standard of care1 Pending approval, this novel complementary immunotherapy combination is positioned to delay disease progression for patients treated as early as second line, with 83% of patients alive at three years1 BEERSE, BELGIUM, June 26, 2026 (GLOBE NEWSWIRE) -- Johnson & Johnson
About this update from Johnson & Johnson
BEERSE, BELGIUM, June 26, 2026 (GLOBE NEWSWIRE) -- Johnson & Johnson today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of an indication extension of TECVAYLI® (teclistamab) in combination with daratumumab for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior therapy. Advancing complementary immunotherapies to improve patient outcomesTeclistamab and daratumumab work in a mechanistically complementary manner by engaging multiple tumour and immune directed pathways.1,2 When combined, daratumumab modulates the immune system to create a more favourable immune microenvironment and enhances T-cell fitness and activation, amplifying teclistamab-mediated killing of myeloma cells.1,2 This combination improves patient outcomes by using immunotherapies earlier in the treatment journey when patients' immune systems are more robust.1,2 Expert and company perspectives support the earlier use of teclistamab combination in multiple myeloma care"Unprecedented data show a meaningful extension in overall survival and minimal progression events observed after the first six months. More than 90% of patients receiving the combination who were progression-free at six months remained progression-free at three years, highlighting the potential for durable long-term disease control." said Ester in 't Groen, EMEA Therapeutic Area Head, Haematology, Johnson & Johnson. "This CHMP opinion marks an important step towards establishing the off-the-shelf immunotherapy combination of teclistamab plus daratumumab as a new standard of care earlier in the treatment pathway for multiple myeloma." "At Johnson & Johnson our ambition is to leverage the full potential of our comprehensive multiple myeloma portfolio, to strengthen patient outcomes at every stage of the treatment continuum," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. "By advancing innovative immunotherapies such as teclistamab and combining them with a well-established standard of care like daratumumab, we are building on our deep scientific expertise to deliver more integrated, combination-based approaches that can continue to raise expectations for patient care."