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Ono Pharmaceutical’s Opdivo (nivolumab) + Yervoy (ipilimumab) Receives the MFDS Approval as 1L Treatment of Esophageal Squamous Cell Carcinoma in South Korea

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Ono Pharmaceutical’s Opdivo (nivolumab) + Yervoy (ipilimumab) Receives the MFDS Approval as 1L Treatment of Esophageal Squamous Cell Carcinoma in South Korea

Shots:

  • The MFDS has approved Opdivo (IV) for unresectable advanced or metastatic ESCC with tumor cell PD-L1 expression ≥ 1% in combination with Yervoy & CT
  • The approvals were based on the results from the P-III study (CheckMate -648/ONO-4538-50/CA209648) evaluating Opdivo (3mg/kg, q2w) + Yervoy (1mg/kg, q6w for ~ 24mos.) and Opdivo (240mg, q2w) + CT vs CT alone (fluorouracil and cisplatin combination therapy)
  • The combination therapy showed a significant clinical improvement in OS at the pre-specified interim analysis in patients with tumor cell PD-L1 expression ≥1% & an all-randomized patient population. The safety profiles were consistent with prior reported studies

 Ref: Ono Pharmaceutical | Image: Ono Pharmaceutical

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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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