Oncology latest news
Below you’ll find the most recent oncology news across Johnson & Johnson.
New TECVAYLI® data demonstrates superior progression-free and overall survival as early as first relapse in multiple myeloma
• Building on the recent approval of TECVAYLI® plus DARZALEX FASPRO®, MajesTEC-9 is the second positive Phase 3 study to reinforce the strength of TECVAYLI® as early as second line • TECVAYLI®delivered deep and durable responses, with nearly two-thirds of patients achieving a complete response or better
U.S. FDA Approval of RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) Enables the Simplest, Shortest Administration Time for a First-Line Combination Regimen when combined with LAZCLUZE® (lazertinib)
RYBREVANT FASPRO™, the first and only subcutaneous therapy for patients with EGFR-mutated NSCLC, reduces administration time from hours to minutes and significantly reduces administration-related reactions1-5 Approval builds on previously reported Phase 3 MARIPOSA data showing unmatched overall survival benefit of this chemotherapy-free regimen, projected to exceed four years6
Johnson & Johnson enters new era in solid tumors at ESMO 2025 with promising data across multiple cancer types
First report of subcutaneous amivantamab demonstrates compelling clinical activity in recurrent or metastatic head and neck cancer, building on strength in colorectal cancer and EGFR-mutated lung cancer New analysis and recent U.S. FDA Fast Track designation underscore promise of first-in-class pasritamig for prostate cancer
Data published in The New England Journal of Medicine demonstrate RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE® (lazertinib) is re-setting survival expectations in first-line EGFR-mutated lung cancer
Chemotherapy-free combination regimen ushers in new era for first-line treatment, with overall survival projected to exceed four years, surpassing monotherapy TKI osimertinib by more than one year
European Commission approves DARZALEX® (daratumumab) as the first licensed treatment for patients with high-risk smouldering multiple myeloma
Landmark approval is based on results from the Phase 3 AQUILA study, showing fixed-duration treatment with daratumumab significantly reduced the risk of progression to active multiple myeloma or death by 51 percent compared to active monitoring1 This milestone marks a critical advance in early intervention for multiple myeloma as the first authorised treatment, offering a new treatment paradigm for patients with high-risk smouldering disease2
European Commission approves IMBRUVICA® (ibrutinib) as the first targeted therapy for patients with previously untreated mantle cell lymphoma who would be eligible for autologous stem cell transplant
Ibrutinib is the first approved Bruton’s tyrosine kinase (BTK) inhibitor to demonstrate statistically meaningful outcomes versus autologous stem cell transplant (ASCT) for the frontline treatment of transplant eligible patients with mantle cell lymphoma1 Data from the Phase 3 TRIANGLE study defines the fixed-duration ibrutinib-based regimen as a new standard of care (SOC) with significantly improved overall survival and failure-free survival versus ASCT1
Johnson & Johnson unveils highly anticipated and potential practice-changing data in bladder cancer treatment at AUA
TAR-200 monotherapy shows highest complete response with sustained benefits in 12-month data from Phase 2b SunRISe-1 study (Cohort 2) Compelling first results from Cohort 4 of Phase 2b SunRISe-1 study show potential of TAR-200 monotherapy in patients with papillary-only, high-risk non-muscle invasive bladder cancer
RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) significantly outperforms standard of care in first-line EGFR-mutated lung cancer with compelling new data at ELCC 2025
Median overall survival improvement projected to exceed one year with much-anticipated overall survival analysis showing statistically superior result versus osimertinib Preventative dermatologic regimen meets primary endpoint and enhances patient experience
Johnson & Johnson’s DARZALEX® (daratumumab) subcutaneous-based regimen receives positive CHMP opinion for patients with newly diagnosed multiple myeloma, regardless of transplant eligibility
If approved, daratumumab will be the only anti-CD38 available for all patient types across newly diagnosed multiple myeloma, cementing daratumumab as a foundational therapy in the frontline setting. Recommendation supported by results from CEPHEUS, the fifth Phase 3 study of daratumumab to demonstrate improved progression free survival in the frontline setting.1,2,3,4
CHMP recommends subcutaneous RYBREVANT®▼ (amivantamab) for the treatment of patients with advanced EGFR-mutated non-small cell lung cancer
Data from the Phase 3 PALOMA-3 study showed non-inferiority to intravenous administration meeting both co-primary pharmacokinetic (PK) endpoints, as well as a five-fold reduction in infusion-related reactions and fewer venous thromboembolic events1 CHMP has issued a positive opinion for an extension of marketing authorisation for subcutaneous amivantamab dosed every two weeks
European Commission approves LAZCLUZE®▼ (lazertinib) in combination with RYBREVANT®▼ (amivantamab) for the first-line treatment of patients with EGFR-mutated advanced non-small cell lung cancer
Latest topline data from the Phase 3 MARIPOSA study shows amivantamab plus lazertinib is the first regimen to demonstrate superior overall survival benefit compared to the current standard of care osimertinib1 Median overall survival improvement is expected to exceed one year1
New Drug Application initiated with U.S. FDA for TAR-200, the first and only intravesical drug releasing system for patients with BCG-unresponsive high-risk non-muscle-invasive bladder cancer
Application accepted for U.S. FDA Real-Time Oncology Review (RTOR) based on Phase 2b SunRISe-1 study showing highest single-agent complete response rate of 83.5 percent1
News Archive
Looking for more news? Visit the archive to see a full list of oncology updates from the past several years.
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