Tevimbra seeks to add 6 indications in Korea

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: ▲First-line combination therapy for patients with unresectable, locally advanced, or metastatic esophageal cancer; ▲First-line combination therapy for patients with unresectable or metastatic, HER2-negative gastric cancer or gastroesophageal junction adenocarcinoma; and ▲First-line combination and second-line monotherapy therapy for non-small cell lung cancer (NSCLC).

 

Tevimbra has already been approved by the U.S.

 

Food and Drug Administration (FDA) for a first- and second-line treatment for patients with unresectable or metastatic esophageal squamous cell carcinoma, as well as for the first-line treatment for patients with advanced gastric cancer (GC).

 

The drug has been expanding its indications in the global market.

 

The European Medicines Agency (EMA) has approved Tevimbra as a first- and second-line treatment of esophageal squamous cell carcinoma, a first-line treatment of advanced gastric cancer, and as a first- and second-line treatment of non-small cell lung cancer (NSCLC).

 

In line with the global trend, Tevimbra’s role is expected to expand to treating various types of cancer in Korea in the future as well.

 

Tevimbra is an immuno-oncology drug with a PD-1 inhibition mechanism of action that recently demonstrated clinical efficacy in second-line treatment of esophageal squamous cell carcinoma, was approved in Korea in November last year and became the first immuno-oncology drug to be reimbursed for esophageal cancer in March this year.

 

This drug is designed based on the technological expertise of BeOne Medicines and employs a dual mechanism of action that effectively blocks PD-L1 while minimizing binding to Fc-gamma receptors (FcγR), thereby inducing potent antitumor responses through a mechanism distinct from that of existing immuno-oncology agents.

 

Notably, it demonstrated superior PD-L1 blocking efficacy (>99%) compared to other immunotherapy agents of the same class, and according to the company, it has a higher binding affinity and a half-life 30-80 times longer than existing drugs, suggesting a more sustained therapeutic effect.

 

Based on this unique mechanism of action, Tevimbra demonstrated treatment efficacy by significantly improving overall survival rates compared to chemotherapy in patients with esophageal squamous cell carcinoma, where over 70% of patients have low or no PD-L1 expression, regardless of PD-L1 expression status.

 

Meanwhile, BeOne Medicines Ltd.

 

recently changed its name from Beigene and relocated its corporate headquarters to Switzerland, marking its new beginning.