Oncology news archive

Approval based on compelling safety and efficacy from the Phase 3 MARIPOSA-2 study, marking the third new indication for RYBREVANT® this year, with four indications overall

TAR-200 plus cetrelimab effective in reducing tumor size in those with muscle-invasive disease, potentially improving surgical outcomes and lowering risk of recurrence

Investigational TAR-200 monotherapy demonstrates high complete response rate without the need for reinduction or additive therapy in patients who are Bacillus Calmette-Guérin (BCG)-unresponsive

Median duration of response reaches 7.4 months with combination treatment in patients with aggressive form of disease New results show potential of RYBREVANT® beyond lung cancer

Post-progression outcomes showed significant and sustained improvement for RYBREVANT® plus standard of care versus chemotherapy alone

Pre-medication regimen showed an infusion-related reaction rate of 22.5 percent with intravenous RYBREVANT®, a three-fold reduction from 67.4 percent historically seen with standard IRR management

New longer-term data from the MARIPOSA study confirm superior outcomes of chemotherapyfree RYBREVANT® plus LAZCLUZE™ regimen compared to osimertinib monotherapy as firstline therapy Results from an interim analysis featured in late-breaker oral presentation at WCLC

Patients with EGFR ex19del or EGFR L858R mutations, the most common EGFR mutations in NSCLC, have until now faced a poor prognosis and limited treatment options after disease progression on an EGFR TKI1,2,3,4 Amivantamab in combination with chemotherapy is the first treatment regimen to show significant improvement in progression-free survival compared to chemotherapy alone in this patient population5

Four RYBREVANT® (amivantamab-vmjw) studies feature compelling new findings in lung and colorectal cancers New TAR-200 data reveal the potential of organ-sparing therapy for the treatment of bladder cancer

First pan FGFR kinase inhibitor to be approved in the European Economic Area, for adults with unresectable or metastatic urothelial carcinoma and susceptible FGFR3 alterations Approval based on THOR results, showing 36 percent reduction in risk of death with erdafitinib versus chemotherapy1

RYBREVANT® plus LAZCLUZE™ is the first and only chemotherapy-free regimen showing superior progression-free survival versus osimertinib Following Priority Review, approval is based on Phase 3 MARIPOSA results showing RYBREVANT® plus LAZCLUZE™ reduced the risk of disease progression or death by 30 percent versus osimertinib, with a nine-month-longer median duration of response

Patients with EGFR ex19del or EGFR L858R mutations, the most common EGFR mutations in NSCLC, currently face a poor prognosis and limited treatment options after disease progression on osimertinib1,2,3,4 In the MARIPOSA-2 study, amivantamab in combination with chemotherapy significantly reduced the risk of disease progression or death by 52 percent compared to chemotherapy alone, and is the first treatment regimen to show improvement in progression-free survival in this patient population5

Findings from first-ever quadruplet therapy study with subcutaneous DARZALEX FASPRO® showed 60 percent reduction in risk of disease progression or death New regimen solidifies DARZALEX FASPRO® as a foundational frontline therapy in multiple myeloma with potential to significantly delay disease progression

CARVYKTI ® is the first and only BCMA-targeted CAR-T cell therapy approved by the U.S. FDA for the treatment of patients with multiple myeloma who have had at least one prior line of therapy

Application based on Phase 3 PALOMA-3 results showing five-fold reduction in infusion-related reactions with five-minute administration of subcutaneous amivantamab Longer overall survival, progression-free survival and duration of response also observed with subcutaneous amivantamab

24-month overall survival rate of 67 percent achieved with TALVEY® 0.8 mg/kg biweekly dosing in the Phase 1/2 MonumenTAL-1 study

RESONATE-2 data presented at the 2024 European Hematology Association (EHA) Congress provide longest-term outcomes and safety data ever reported for a monotherapy BTK inhibitor, with a median progression-free survival of 8.9 years1 Additional findings from pooled analysis of three Phase 3 studies showed treatment with ibrutinib has the potential to achieve comparable overall survival to the general European population2

At 5 years, 67 percent of patients were progression-free, with overall survival at 96 percent for all treated patients1