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Oncology
RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) approved in the U.S. as a first-line chemotherapy-free treatment for patients with EGFR-mutated advanced lung cancer
August 20, 2024
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Oncology
DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based quadruplet regimen approved in the U.S. for patients with newly diagnosed multiple myeloma who are transplant-eligible
July 31, 2024
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Oncology
CHMP recommends RYBREVANT®▼ (amivantamab) in combination with chemotherapy for the treatment of adult patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC) after failure of prior therapy
July 26, 2024
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Oncology
CHMP adopts positive opinion for BALVERSA
®
(erdafitinib) for the treatment of adult patients
Pending approval, erdafitinib would become the first therapy targeting FGFR3 alterations in patients with metastatic urothelial carcinoma, one of Europe’s most common cancers
1
The CHMP’s recommendation is based on results from Cohort 1 of the Phase 3 THOR study, which showed a 36 percent reduction in the risk of death with erdafitinib versus chemotherapy
2
June 28, 2024
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Oncology
Subcutaneous amivantamab Biologics License Application submitted to U.S. FDA for patients with EGFR-mutated non-small cell lung cancer
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
June 17, 2024
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Oncology
TALVEY
®
(talquetamab-tgvs) demonstrates highly durable, longer-term responses in patients with relapsed or refractory multiple myeloma
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
June 14, 2024
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Oncology
Findings from landmark RESONATE-2 study confirm sustained survival benefit of IMBRUVICA
®
(ibrutinib) for first-line chronic lymphocytic leukaemia treatment with up to 10 years follow-up
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 years
1
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 population
2
June 14, 2024
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Oncology
Updated Phase 2 CAPTIVATE study results demonstrate sustained clinical benefit of fixed-duration IMBRUVICA
®
(ibrutinib) plus venetoclax as first-line treatment for patients with chronic lymphocytic leukaemia, including those with high-risk disease
At 5 years, 67 percent of patients were progression-free, with overall survival at 96 percent for all treated patients
1
June 14, 2024
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Oncology
First results from late-breaking Phase 3 PALOMA-3 study show five-fold reduction in infusion-related reactions with five-minute subcutaneous amivantamab administration
New formulation showed non-inferiority to intravenous administration in fourth positive Phase 3 study in RYBREVANT
®
clinical program
Longer overall survival, progression-free survival and duration of response shown with subcutaneous amivantamab; featured in Best of ASCO 2024
RYBREVANT
®
marketing application submitted to European Medicines Agency based on PALOMA-3 study
June 3, 2024
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Oncology
DARZALEX
®
(daratumumab)-based regimens significantly improve clinical outcomes in both transplant-eligible and -ineligible patients who are newly diagnosed with multiple myeloma
88 percent of transplant-eligible patients achieved a complete response or better, and 47 percent of patients sustained MRD-negativity for longer than one year with DARZALEX FASPRO
®
(daratumumab and hyaluronidase-fihj)-based induction, consolidation and maintenance regimens in the Phase 3 PERSEUS study
7.5 years median overall survival achieved with DARZALEX
®
-based regimen in Phase 3 MAIA final analysis is the longest reported in patients ineligible for transplant
June 3, 2024
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