Drug Approval | July 02, 2024
Lynparza and Imfinzi combination recommended for approval in the EU by CHMP for recurrent endometrial cancer
Imfinzi also recommended for patients with mismatch repair deficient disease
Imfinzi also recommended for patients with mismatch repair deficient disease
Doses will be ready to ship to applicable EU member states immediately upon authorization by the European Commission
Approval based on CAPItello-291 results which showed this combination reduced the risk of disease progression or death by 50% vs. Faslodex alone in a biomarker-altered population
Recommendation based on FLAURA2 results which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly 9 months
Ulcerative Colitis (UC) is a chronic, idiopathic, immune-mediated inflammatory bowel disease (IBD) affecting the large intestine
Recommendation based on CAPItello-291 results which showed the Truqap combination reduced the risk of disease progression or death by 50%
If approved, the Opdivo-based regimen would be the first immunotherapy-chemotherapy combination approved for this patient population in the EU
If approved in the European Union, Fruquintinib will be the first novel targeted therapy for Metastatic Colorectal Cancer regardless of biomarker status in over a decade
ALPHA Phase III trial showed first-in-class, oral, Factor D inhibitor as add-on to Ultomiris or Soliris improved haemoglobin levels and reduced anaemia and fatigue
Decision marks the first approval in Europe for an anti-PD-1/L1 therapy in resectable NSCLC based on positive overall survival results
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