Janssen-Cilag International NV

Phase 3 CARTITUDE-4 study shows cilta-cel significantly increases MRD negativity rates in RRMM patients, with 89% achieving MRD negativity. Cilta-cel, a CAR-T therapy, extends OS and PFS versus standard therapies, demonstrating deep, sustained responses and redefining multiple myeloma treatment.

Janssen-Cilag announces TECVAYLI® (teclistamab) data from MajesTEC-5 and MajesTEC-4 studies showing 100% MRD negativity in newly diagnosed multiple myeloma patients, presented at ASH 2024.

Janssen-Cilag announces TECVAYLI® (teclistamab) data from MajesTEC-5 and MajesTEC-4 studies, showing 100% MRD negativity in newly diagnosed multiple myeloma patients, presented at 2024 ASH Annual Meeting.

DARZALEX® (daratumumab) SC significantly delayed progression from high-risk smouldering multiple myeloma (SMM) to active multiple myeloma (MM) and extended overall survival in the Phase 3 AQUILA study, compared to active monitoring. The study showed potential to prevent end-organ damage and extend progression-free survival.

J&J's Janssen-Cilag receives CHMP recommendation for Lazcluze + Rybrevant in advanced NSCLC with EGFR mutations, based on a phase 3 study showing a 30% reduction in progression or death risk compared to osimertinib.

Janssen-Cilag International NV, a Johnson & Johnson company, announced that the European Medicines Agency's CHMP recommended approval of Lazcluze with Rybrevant for EGFR-mutated advanced NSCLC. The CHMP also recommended a Type II indication extension for amivantamab in the same combination. These recommendations are supported by the Phase III MARIPOSA study, which showed a 30% reduction in disease progression or death compared to Tagrisso, with a median progression-free survival of 23.7 months versus 16.6 months for Tagrisso.

Janssen-Cilag International NV announced CHMP's recommendation for LAZCLUZE (lazertinib) and RYBREVANT (amivantamab) for first-line treatment of advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations. The combination could establish a new standard of care, potentially delaying disease progression and improving outcomes.

Amivantamab plus lazertinib may set new standard for first-line treatment of advanced NSCLC with EGFR ex19del or L858R mutations, reducing progression risk by 30% vs. osimertinib in MARIPOSA study.

Janssen-Cilag International NV submits regulatory applications to FDA and EMA for daratumumab to treat high-risk smouldering multiple myeloma, potentially becoming the first treatment option for this condition.

Janssen-Cilag International NV submits regulatory applications to the FDA and EMA for DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) and DARZALEX (daratumumab) SC for high-risk smouldering multiple myeloma, supported by Phase 3 AQUILA study data. Daratumumab could become the first treatment for this condition, potentially shifting the treatment paradigm.