JANSSEN BIOTECH, INC.
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Subsidiary
- Established
- 1979-01-01
- Employees
- 10K
- Market Cap
- -
FDA Advisory Committee Votes 6-2 in Favor of Daratumumab for High-Risk Smoldering Multiple Myeloma
• The FDA's Oncologic Drug Advisory Committee (ODAC) voted 6-2 that daratumumab (Darzalex Faspro) demonstrates a favorable benefit-risk profile for patients with high-risk smoldering multiple myeloma, potentially offering the first approved therapy for this precursor condition.
• The phase 3 AQUILA trial showed daratumumab significantly delayed progression to active multiple myeloma with a 51% reduction in risk of progression or death compared to active monitoring, with 5-year PFS rates of 63.1% versus 40.8%.
• Committee members expressed concerns about risk classification accuracy and potential overtreatment, but ultimately determined the benefits outweighed risks for this malignant condition that has an 80% five-year progression risk to symptomatic multiple myeloma.
Genmab Reports Strong Q1 2025 DARZALEX Sales of $3.24 Billion, Demonstrating Continued Market Dominance
• DARZALEX (daratumumab) generated $3.24 billion in global net sales during Q1 2025, with $1.83 billion from U.S. markets and $1.41 billion internationally.
• Genmab receives royalties on all worldwide sales of both intravenous DARZALEX and the subcutaneous formulation (DARZALEX FASPRO in the U.S.) through its licensing agreement with Johnson & Johnson.
• The strong Q1 performance supports analysts' projections of 15.1% annual revenue growth for Genmab over the next three years, despite the company's stock currently trading at a significant discount to target prices.
DARZALEX® Subcutaneous Regimen Receives CHMP Backing for Newly Diagnosed Multiple Myeloma Treatment
• Johnson & Johnson's DARZALEX® subcutaneous formulation combined with VRd receives positive CHMP recommendation for treating newly diagnosed multiple myeloma patients, regardless of transplant eligibility.
• The recommendation is supported by the Phase 3 CEPHEUS study, which evaluated the efficacy of daratumumab-VRd compared to VRd alone in 395 patients with newly diagnosed multiple myeloma.
• DARZALEX® has demonstrated significant impact in multiple myeloma treatment, having been used in over 618,000 patients worldwide and currently approved in eight indications.
STELARA® Receives CHMP Backing for Pediatric Crohn's Disease Treatment in Europe
• The European Medicines Agency's CHMP has recommended expanding STELARA® (ustekinumab) approval for treating moderate to severe Crohn's disease in children weighing at least 40 kg who failed conventional or biologic therapy.
• Phase 3 UNITI-Jr trial demonstrated strong efficacy with 52.1% of pediatric patients achieving clinical remission at week 8, with safety profile comparable to adult studies.
• The treatment addresses a critical need in pediatric Crohn's disease, which significantly impacts children's growth, development, and mental health, affecting their overall quality of life.
Protagonist Therapeutics Reports Strong Financial Growth with Key Clinical Milestones Ahead in Q1 2025
• Protagonist Therapeutics secured a significant $165 million milestone payment for icotrokinra in Q4 2024, strengthening their financial position with total cash reserves of $559.2 million.
• The company anticipates crucial Phase 3 VERIFY trial results for rusfertide in polycythemia vera and Phase 2b ANTHEM trial data for icotrokinra in ulcerative colitis by March 2025.
• Protagonist advanced their pipeline with PN-881, a novel oral IL-17 receptor antagonist, while maintaining strong partnerships with Takeda and Johnson & Johnson for their lead programs.
Real-World Study Evaluates Bispecific Antibody Use in Relapsed/Refractory Multiple Myeloma
• A real-world study examined bispecific antibody use in relapsed/refractory multiple myeloma patients, revealing that 44.67% of evaluable patients received these agents in 2023.
• The research integrates structured and unstructured data, using AI to convert visit notes into structured data, enhancing the analysis of treatment patterns.
• Future analysis will focus on safety profiles and comparing real-world outcomes with prospective clinical trial data to assess effectiveness.
• The study aims to understand the evolving patterns of care associated with bispecific antibodies in a larger cohort over the next few years.
J&J Seeks FDA Approval for TAR-200 in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
• Johnson & Johnson has initiated a New Drug Application (NDA) submission to the FDA for TAR-200.
• TAR-200 is intended for patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC).
• Phase 2b SunRISe-1 study data showed an 83.5% complete response rate with TAR-200 monotherapy.
• The FDA is reviewing the application under the Real-Time Oncology Review (RTOR) program to expedite potential approval.
Nipocalimab Receives FDA Priority Review for Generalized Myasthenia Gravis Treatment
• The FDA granted Priority Review to nipocalimab for treating gMG in antibody-positive patients, expediting its potential availability to patients.
• Phase 3 Vivacity-MG3 study results supported the application, demonstrating sustained disease control and significant MG-ADL score reduction.
• Nipocalimab, a monoclonal antibody, aims to reduce IgG autoantibodies, addressing the underlying cause of gMG without broad immunosuppression.
• Johnson & Johnson also submitted a Marketing Authorisation Application to the EMA, seeking approval of nipocalimab in gMG in Europe.
BeiGene's BRUKINSA Receives European Commission Approval for CLL Treatment
The European Commission has approved BeiGene's BRUKINSA (zanubrutinib) for treating adults with chronic lymphocytic leukemia (CLL), marking a significant advancement in chemotherapy-free treatment options. BRUKINSA has shown superior efficacy and a favorable safety profile in clinical trials.
RYBREVANT and LAZCLUZE Combination Shows Significant Survival Improvement in EGFR-Mutated NSCLC
• Johnson & Johnson's RYBREVANT plus LAZCLUZE demonstrates statistically significant and clinically meaningful improvement in overall survival (OS) versus osimertinib in EGFR-mutated NSCLC.
• The MARIPOSA Phase 3 study showed the chemotherapy-free combination is expected to improve median OS by over one year compared to the current standard of care.
• RYBREVANT plus LAZCLUZE is approved in the U.S. and Europe as a first-line therapy for NSCLC patients with EGFR exon 19 deletions or L858R substitution mutations.
• The safety profile of the combination was consistent with individual treatments, with venous thromboembolic events managed through prophylactic anticoagulants.
EC Approves Amivantamab Plus Lazertinib for First-Line EGFR-Mutated NSCLC
• The European Commission has approved amivantamab plus lazertinib for first-line treatment of EGFR-mutated non-small cell lung cancer (NSCLC).
• The approval is based on the Phase 3 MARIPOSA trial, which showed superior progression-free survival compared to osimertinib.
• The combination therapy reduced the risk of disease progression or death by 30% compared to osimertinib monotherapy.
• Common adverse events were manageable and primarily Grade 1 or 2, supporting the combination's safety profile.
EMA to Review Ibrutinib for Frontline Mantle Cell Lymphoma in Transplant-Eligible Patients
• Johnson & Johnson seeks EMA approval for ibrutinib plus R-CHOP for untreated MCL patients eligible for autologous stem cell transplant.
• The application is based on the Phase 3 TRIANGLE study, which showed improved efficacy with ibrutinib-based regimens.
• TRIANGLE study investigated ibrutinib with immunochemotherapy, with and without transplant, compared to standard immunochemotherapy followed by transplant.
• Ibrutinib, a BTK inhibitor, has the potential to replace or complement transplant in frontline MCL treatment, according to the study.
CAR-T Therapies Idecabtagene Vicleucel and Ciltacabtagene Autoleucel Show Promise in Multiple Myeloma Treatment
• Idecabtagene vicleucel (ide-cel) demonstrated high rates of complete response and minimal residual disease negativity in multiple myeloma patients after suboptimal response to standard first-line therapy.
• Ciltacabtagene autoleucel (cilta-cel) showed significantly higher rates of minimal residual disease negativity compared to standard of care in lenalidomide-refractory multiple myeloma.
• Cilta-cel's sustained MRD negativity translated to prolonged progression-free survival, with over 93% of patients remaining progression-free for more than 30 months.
• Both ide-cel and cilta-cel highlight the potential of CAR-T cell therapy in achieving deep and durable responses in multiple myeloma patients.
Johnson & Johnson Seeks FDA Approval for Tremfya to Treat Pediatric Psoriasis and Arthritis
• Johnson & Johnson has submitted sBLAs to the FDA for Tremfya (guselkumab) to treat moderate-to-severe plaque psoriasis in children aged 6 and older.
• The submission also seeks approval for Tremfya to treat active juvenile psoriatic arthritis in children aged 5 and older.
• The sBLAs are based on data from the Phase 3 PROTOSTAR study and pharmacokinetic data from adult studies VOYAGE 1 and 2, and DISCOVER 1 and 2.
• Tremfya, an IL-23 inhibitor, is already approved for adults with plaque psoriasis, psoriatic arthritis, and ulcerative colitis.
J&J's Oral IL-23 Inhibitor Icotrokinra Achieves Positive Phase 3 Results in Psoriasis
• Johnson & Johnson's icotrokinra met primary endpoints in the ICONIC-LEAD phase 3 trial, demonstrating significant skin clearance in psoriasis patients.
• After 16 weeks, 64.7% of patients achieved clear or almost clear skin (IGA 0/1), and 49.6% showed a 90% or greater improvement in PASI score.
• Icotrokinra's tolerability profile was consistent with previous phase 2 studies, with similar adverse event rates compared to placebo.
• J&J plans to submit icotrokinra for regulatory approval, positioning it as a potential oral alternative to injectable biologics for psoriasis.
Icotrokinra Shows Promising Phase 3 Results for Plaque Psoriasis Treatment
• Phase 3 trials show Icotrokinra significantly improved skin clearance in adults and adolescents with moderate to severe plaque psoriasis.
• At week 16, 64.7% of patients achieved clear or almost clear skin (IGA 0/1) with Icotrokinra, compared to 8.3% on placebo.
• Icotrokinra, a once-daily oral peptide selectively blocking the IL-23 receptor, demonstrated a safety profile consistent with earlier studies.
• Further improvements were seen at week 24, with 74.1% achieving IGA 0/1 and 64.9% achieving PASI 90, highlighting sustained efficacy.
CHMP Recommends Subcutaneous Amivantamab for EGFR-Mutated NSCLC Treatment
• The CHMP has recommended subcutaneous amivantamab with lazertinib for first-line treatment of NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations.
• Subcutaneous amivantamab monotherapy is recommended for NSCLC with EGFR exon 20 insertion mutations after platinum-based therapy failure.
• PALOMA-3 study results support the recommendation, showing non-inferior pharmacokinetics and a five-fold reduction in infusion-related reactions compared to IV administration.
• The subcutaneous formulation reduces administration time to approximately five minutes, offering improved convenience and safety for patients.
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