Oncology news archive

Expanded indication for this one-time infusion may provide patients with a potential period away from their multiple myeloma treatment as early as first relapse1 Approval is based on results from the PHASE 3 CARTITUDE-4 study, in which treatment with cilta-cel in 1-3 prior lines of therapy reduced the risk of disease progression or death by 74 percent compared to standard therapies1

Expanded indication for this one-time infusion will provide more patients with a potential period away from their multiple myeloma treatment as early as first relapse Approval is based on results from the Phase 3 CARTITUDE-4 study, in which treatment with CARVYKTI® in 1-3 prior lines of therapy reduced the risk of disease progression or death by 59 percent compared to standard therapies

Featured data include new results from the Phase 3 MARIPOSA study, which has received U.S. FDA Priority Review, and the Phase 1b PALOMA study of subcutaneous amivantamab

FDA ODAC unanimously votes 11 to 0 supporting favorable risk-benefit assessment of CARVYKTI® based on results from the Phase 3 CARTITUDE-4 study

Acquisition strengthens Johnson & Johnson’s commitment to innovation in prostate cancer and deepens pipeline of next-generation antibody drug conjugates and targeted oncologic therapeutics

Submission supported by data from Phase 3 PERSEUS study, which showed the daratumumab subcutaneous formulation-based regimen significantly reduced the risk of progression or death, compared to standard of care regimen.1

Approval is based on results from the Phase 3 PAPILLON study, which demonstrated RYBREVANT® plus chemotherapy reduced the risk of disease progression or death by 61 percent versus chemotherapy alone in patients with previously untreated NSCLC with EGFR exon 20 insertion mutations National Comprehensive Cancer Network ® (NCCN ®) updated its NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ®) to recommend amivantamab-vmjw (RYBREVANT®) plus chemotherapy as a preferred first-line regimen for patients with NSCLC with EGFR exon 20 insertion mutations

IMBRUVICA® is now the only Bruton’s tyrosine kinase inhibitor (BTKi) approved with an oral suspension formulation, providing additional flexibility for patients who may have difficulty swallowing tablets or capsules

Results from the Phase 3 CARTITUDE-4 study, which supported the CHMP recommendation, showed that cilta-cel has the potential to offer significant benefit to patients in earlier lines of treatment1 Most patients with multiple myeloma relapse after current standard treatments and remain in need of additional therapeutic options at earlier stages of the disease1

Biweekly dosing with TECVAYLI®, the first approved BCMA-targeting bispecific antibody, provides patients with dosing flexibility

The submission is supported by data from the Phase 3 MARIPOSA study, showing statistically significant and clinically meaningful improvement in progression-free survival in patients with EGFR-mutated advanced NSCLC treated with amivantamab plus lazertinib versus osimertinib1 Amivantamab is a fully-human EGFR-MET bispecific antibody with immune cell-directing activity that targets tumours with activating and resistance EGFR mutations and MET mutations and amplifications2,3,4,5

Data supporting the application showed the addition of DARZALEX FASPRO® to lenalidomide, bortezomib and dexamethasone (VRd) induction and consolidation and lenalidomide maintenance therapy reduced the risk of progression or death by 58 percent compared to standard of care If approved, the DARZALEX FASPRO®-based regimen has the potential to provide an effective quadruplet therapy for many patients with newly diagnosed multiple myeloma who are eligible for transplant

Clinical and real-world evidence data support treatment with ERLEADA® (apalutamide) and niraparib plus abiraterone acetate given with prednisone in patients with prostate cancer Additional updates will be presented on innovative targeted releasing systems TAR-200 and TAR-210 in bladder cancer

BALVERSA® is the First and Only Targeted Therapy for Patients with Locally Advanced or Metastatic Urothelial Carcinoma and Susceptible Fibroblast Growth Factor Receptor Alterations Phase 3 THOR Study Showed a 36 Percent Reduction in the Risk of Death with BALVERSA® Versus Chemotherapy in Patients Data were featured at the European Society for Medical Oncology (ESMO) 2023 Congress and in The New England Journal of Medicine

Portfolio of Clinical and Preclinical Programs, Including Lead Product Candidate ARX517, a Prostate-Specific Membrane Antigen (PSMA)-Targeting Antibody Drug Conjugate (ADC), Strengthens Johnson & Johnson’s Commitment to Oncology Innovation Novel Technology Platform Sets Stage for the Development of Next Generation ADCs and Targeted Oncologic Therapeutics

The submission is supported by data from the Phase 3 MARIPOSA study, which featured in a Late-Breaking Presidential Symposium session at the 2023 ESMO Congress1 Lazertinib is a highly selective, central nervous system-penetrant, third-generation EGFR tyrosine kinase inhibitor2,3

Submissions supported by data from landmark Phase 3 MARIPOSA study, which showed statistically significant and clinically meaningful improvement in progression-free survival in patients with EGFR-mutated advanced NSCLC treated with RYBREVANT® plus lazertinib versus osimertinib