The U.S. Food and Drug Administration (FDA) has granted accelerated approval to several treatments for non-small cell lung cancer (NSCLC) and multiple myeloma in mid-2025. On June 23, the FDA approved datopotamab deruxtecan-dlnk for adults with locally advanced or metastatic EGFR-mutated NSCLC who have previously undergone EGFR-directed therapy and platinum-based chemotherapy. Additionally, telisotuzumab vedotin-tllv, a c-Met-directed antibody and microtubule inhibitor conjugate, received accelerated approval for adults with non-squamous NSCLC. The FDA also granted accelerated approval to a treatment for relapsed or refractory multiple myeloma. Furthermore, the FDA has granted fast track designation to a next-generation HER3-directed antibody-drug conjugate (ADC) for EGFR-positive advanced NSCLC. In Europe, the European Commission approved Darzalex® (daratumumab) as the first authorized treatment for patients with high-risk smoldering multiple myeloma, based on data from the Phase 3 AQUILA trial. The European Union also approved Johnson & Johnson's Imbruvica as the first targeted treatment for some untreated mantle cell lymphoma patients. Darzalex Faspro®, a subcutaneous formulation of daratumumab, received European Commission approval for adult patients with smoldering multiple myeloma.
EU clears J&J's Darzalex as first therapy for smouldering multiple myeloma $JNJ https://t.co/CnFBgRPs84
Subcutaneous Daratumumab Receives European Commission Approval in Smoldering Myeloma #mmsm #oncology https://t.co/6QemUI2MXr
European Union Approved Darzalex Faspro® for Adult Patients with Smoldering Multiple Myeloma 🏥🇪🇺