Innovative Medicine
-
Subcutaneous RYBREVANT®▼ (amivantamab) approved by European Commission for every-three-week and every-four-week dosing for patients with advanced EGFR-mutated non-small cell lung cancer
Subcutaneous (SC) amivantamab reduces administration from hours to minutes, with efficacy and safety consistent with intravenous (IV) amivantamab1,2,3,4,5 SC amivantamab is now authorised across all previously approved IV indications, offering fewer administration-related reactions and new dosing options1,2,3,4,5,6 -
TREMFYA® (guselkumab) long-term data show sustained clinical and endoscopic remission in ulcerative colitis through 3 years
More than 80% of those treated with TREMFYA® were in clinical remission and more than 50% were in endoscopic remission at Week 140 of the QUASAR long-term extension study, showing lasting disease control for patients 78% of patients achieved intestinal healing at both the tissue and visual level (histo-endoscopic mucosal improvement) -
RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) plus immunotherapy shows strong clinical benefit with 56 percent overall response rate in first-line recurrent or metastatic head and neck cancer
Ten percent complete response and rapid, durable antitumor activity reported with RYBREVANT FASPRO™; results surpass current standards of care -
RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) receives U.S. FDA Breakthrough Therapy Designation for patients with advanced head and neck cancer
New designation is based on data showing rapid and durable responses in a heavily pretreated patient population and expands the promise of RYBREVANT FASPRO™ beyond lung cancer -
FDA approves RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) as the only EGFR-targeted therapy that can be administered once a month
Monthly dosing reduces treatment visits while maintaining established safety and efficacy1,2 Builds on RYBREVANT FASPRO™ FDA approval to deliver the simplest and fastest combination regimen for EGFR+ non-small cell lung cancer1,3-6 -
Real-world head-to-head analysis shows 51% reduction in risk of death for patients with metastatic castration-sensitive prostate cancer treated with ERLEADA® (apalutamide) versus darolutamide without docetaxel through 24 months
First ever head-to-head analysis compares overall survival outcomes of ERLEADA® versus darolutamide Retrospective study reinforces real-world efficacy of ERLEADA® for patients with mCSPC -
Johnson & Johnson receives CHMP positive opinion for AKEEGA® (niraparib and abiraterone acetate dual action tablet) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) with BRCA1/2 mutations
AMPLITUDE is the first clinical trial to evaluate potential therapies for patients with mHSPC and known HRR gene alterations, with positive results supporting the niraparib-based combination regimen as a new standard of care for patients with BRCA mutations1 Results demonstrate a delay in disease progression and an early trend toward improved overall survival with the niraparib and abiraterone acetate regimen versus standard of care in the treatment of mHSPC1 -
DARZALEX FASPRO®-based quadruplet regimen approved in the U.S. for newly diagnosed patients with multiple myeloma who are transplant ineligible
Quadruplet regimen demonstrated significantly deeper and more durable responses, higher MRD negativity and improved progression-free survival versus a standard of care Approval marks the twelfth indication for DARZALEX FASPRO® and fifth in the newly diagnosed setting, underscoring its role as foundational therapy for both newly diagnosed and relapsed/refractory multiple myeloma patients -
New clinical data highlights CAPLYTA® (lumateperone) as a promising option for achieving remission in adults with major depressive disorder
CAPLYTA® nearly doubled the likelihood of remission at six weeks compared to placebo as an adjunctive therapy to an antidepressant based on pooled data from two Phase 3 studies 65% of patients reached remission with CAPLYTA®, with 43% achieving sustained relief from symptoms, in a six-month open-label extension safety study Newly approved as an adjunctive for major depressive disorder, CAPLYTA® supports the ultimate treatment goal of remission with robust short-term data and long-term open-label safety data