Janssen-Cilag International NV

Janssen-Cilag International NV submitted a Type II variation application to the EMA for IMBRUVICA® (ibrutinib) in combination with R-CHOP for previously untreated mantle cell lymphoma (MCL) patients eligible for autologous stem cell transplant. Supported by the TRIANGLE study, ibrutinib-based regimens showed improved efficacy over standard care, offering a potential alternative to transplant.

The FcRn inhibitor market report by ResearchAndMarkets.com provides insights into historical and competitive landscapes, market trends, emerging drugs, and forecasts from 2020 to 2034. Key players like Johnson & Johnson, UCB Biopharma, Pfizer, and Immunovant are developing FcRn inhibitors for autoimmune diseases. Prominent drugs include VYVGART, RYSTIGGO, and batoclimab, with positive trial results and FDA approvals. The market is expected to grow due to increasing diagnoses and emerging therapies.

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.