EU Clears J&J’s Darzalex and Imbruvica for Two Blood Cancers

The European Commission has approved Johnson & Johnson’s Darzalex Faspro (daratumumab) as the first authorised therapy for adults with high-risk smouldering multiple myeloma, ending a long-standing “watch-and-wait” approach for the precancerous blood disorder. The decision is backed by the Phase 3 AQUILA study, where subcutaneous daratumumab cut the risk of progression or death by 51% compared with active monitoring (hazard ratio 0.49) and delivered a 63.1% five-year progression-free survival rate versus 40.8% for observation. Overall survival at five years reached 93.0% against 86.9% in the control arm. In a separate ruling the Commission cleared Imbruvica (ibrutinib) as the first targeted therapy for certain patients with previously untreated, transplant-eligible mantle cell lymphoma. The green lights expand Johnson & Johnson’s European haematology portfolio and give clinicians new options to intervene earlier in two aggressive B-cell malignancies.