Innovative Medicine

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

Presentations include additional analyses of nipocalimab data from pregnancies at risk for early-onset severe HDFN; Nipocalimab is the only anti-FcRn being studied in this rare and potentially life-threatening two-person disease for which there are no approved non-surgical therapies

Breakthrough Therapy Designation for nipocalimab based on results from the Phase 2 UNITY clinical trial for HDFN Phase 3 clinical trial enrollment underway, representing the only therapy reported to be under clinical development for this serious, life-threatening and rare condition

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 from FRONTIER 1, a Phase 2b clinical trial, show JNJ-2113, the first and only targeted oral peptide that selectively blocks the IL-23 receptor, achieved the primary and all secondary endpoints including PASIa 100 and IGAb 0 responses of 40.5 percent and 45.2 percent, respectively