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  • Tevimbra seeks to add 6 indications in Korea
  • by Eo, Yun-Ho | translator Alice Kang | Jun 12, 2025 06:05am
Final review underway by MFDS... Approval expected within the month
Indication extended to include esophageal cancer, stomach cancer, lung cancer, etc.
The use of the immuno-oncology drug Tevimbra is set to be extended further in Korea.

The Ministry of Food and Drug Safety is in the final stages of reviewing and approving the additional indications for BeOne Medicines Korea¡¯s Tevimbra (tiselizumab). The drug is expected to be approved for the extended indications within the month.

Specifically, the extended indications include its use as: ¡ãFirst-line combination therapy for patients with unresectable, locally advanced, or metastatic esophageal cancer; ¡ãFirst-line combination therapy for patients with unresectable or metastatic, HER2-negative gastric cancer or gastroesophageal junction adenocarcinoma; and ¡ãFirst-line combination and second-line monotherapy
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