抗PD-L1抗体デュルバルマブ、EUの医薬品委員会(CHMP)が局所進行性の切除不能非小細胞肺がんに対する承認について肯定的見解を示す【英・AstraZeneca】

Imfinzi receives positive EU CHMP opinion for locally-advanced, unresectable non-small cell lung cancer

 AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion, recommending a marketing authorisation of Imfinzi (durvalumab) for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥1% of tumour cells and whose disease has not progressed following platinum-based chemotherapy and radiation therapy (CRT). The recommendation is based on the progression-free survival (PFS) and overall survival (OS) primary endpoints of the Phase III PACIFIC trial, and post-hoc subgroup analyses by PD-L1 expression requested by the CHMP.


 


 


 

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