JANSSEN BIOTECH, INC.

Johnson & Johnson submits regulatory applications to FDA and EMA for Darzalex Faspro as monotherapy for high-risk smoldering multiple myeloma, supported by AQUILA study data. Smoldering multiple myeloma, an early precursor to active multiple myeloma, currently not treated until progression, but high-risk patients may benefit from early intervention. First AQUILA study data to be presented at 2024 ASH Annual Meeting.

Johnson & Johnson has submitted applications to the FDA and EMA for DARZALEX FASPRO® to treat high-risk smoldering multiple myeloma, based on Phase 3 AQUILA study data. If approved, it would be the first therapy for this patient population before full-blown disease onset. DARZALEX FASPRO® is currently approved for multiple myeloma indications and is the only subcutaneous CD38-directed antibody treatment. Johnson & Johnson also reported strong Q3 results and raised its full-year guidance, with analyst upgrades following robust sales. The company faces ongoing legal challenges, including a recent $15 million talc cancer case verdict.

A study led by University of Maryland School of Medicine found that daratumumab combined with lenalidomide significantly extends disease-free period and survival in multiple myeloma patients compared to lenalidomide alone. The AURIGA trial showed a 51% MRD-negative conversion rate in the daratumumab group versus 19% in the control group, with a 47% lower risk of disease progression or death after 30 months. The combination therapy, however, led to slightly higher side effects.

CARVYKTI® reduces death risk by 45% in lenalidomide-refractory multiple myeloma patients, significantly extending overall survival in the CARTITUDE-4 study, presented at the 2024 International Myeloma Society Annual Meeting.

Updated MARIPOSA-2 study results show amivantamab plus chemotherapy significantly improves post-progression outcomes and overall survival in previously treated NSCLC patients with EGFR exon 19 deletions or L858R mutations, compared to chemotherapy alone.

Updated Phase 3 MARIPOSA-2 study results show RYBREVANT® (amivantamab) plus chemotherapy significantly improves post-progression outcomes and overall survival in previously treated non-small cell lung cancer (NSCLC) patients with EGFR exon 19 deletions or L858R mutations, compared to chemotherapy alone.

Updated MARIPOSA-2 study results show amivantamab plus chemotherapy significantly improves post-progression outcomes and overall survival in previously treated NSCLC patients with EGFR exon 19 deletions or L858R mutations, compared to chemotherapy alone.