Domestic approval application filed for 'Voranigo' in KOR

A new malignant brain tumor therapy after over 20 years

MFDS has initiated the review…designated as an orphan drug last year

The efficacy of the drug was proven through the Phase 3 INDIGO study

Product photo of Voranigo

New drug 'Voranigo' for malignant brain tumors has entered domestic approval procedure.

 

According to the industry sources, Servier Korea has recently submitted approval application to the Ministry of Food and Drug Safety (MFDS) for Voranigo (vorasidenib).

 

In Sepetember last year, this drug was designated an orphan drug in South Korea.

 

Voranigo is indicated for the treatment of diffuse gliomas with an isocitrate dehydrogenase (IDH) mutation.

 

Voranigo targets patients with low-grade gliomas who are vulnerable to IDH1 or IDH2 mutations.

 

This drug is a bispecific inhibitor of IDH1/2, developed by multinational pharmaceutical company Servier.

 

It targets glioma (astrocytoma or oligodendroglioma), a type of brain tumor that is difficult to treat.

 

Voranigo received the final approval from the U.S.

 

Food and Drug Administration (FDA) in August 2024 and is in the process of getting approved in countries worldwide, including Europe.

 

The efficacy of Voranigo was demonstrated through the Phase 3 INDIGO study.

 

The study results were presented at last year's American Society of Clinical Oncology (ASCO) Annual Meeting.

 

The study results showed that in patients with glioma who have IDH mutation, the drug significantly reduced the tumor progression or death risk by 61% compared to the placebo.

 

Voranigo also reduced the risk of requiring further treatments by 74%.

 

The study participants had no history of undergoing treatments other than surgery.

 

Voranigo also showed favorable drug tolerance.

 

Its safety profile was similar to the Phase 1 clinical trial case results.

 

Meanwhile, glioma is the most common type of primary malignant brain tumor in adults, and almost all adult patients (grade 2 diffuse gliomas) are likely to have IDH1 or IDH2 mutation.

 

These patients are currently treated with off-label (medicines approved for other uses) instead of officially approved medicines.

 

In addition to Voranigo monotherapy, Servier is currently conducting clinical trials for concurrent use of the drug with MSD's immune checkpoint inhibitor, 'Keytruda (ingredient: pembrolizumab),' in patients with relapsed and advanced gliomas who have IDH1 mutation.

 

The company already has 'Tibsovo (IDH1 inhibitor)' and a 'IDH2 inhibitor' in its IDH inhibitor pipeline.