India clears new brain-cancer drug, expected at lower price than US and Europe
Servier India to launch Vorasidenib (Voranigo), a targeted therapy for patients with Grade 2 IDH-mutant glioma
- Dec 10, 2025,
- Updated Dec 10, 2025 4:02 PM IST
India will get its first major treatment for a rare form of brain cancer in more than 25 years, with the drug regulator clearing Servier India to launch Vorasidenib (Voranigo), a targeted therapy for patients with Grade 2 IDH-mutant glioma.
The Central Drugs Standard Control Organisation (CDSCO) granted approval after the medicine was cleared by the US Food and Drug Administration in August 2024 and by European regulators in September 2025 an unusually quick turnaround for an orphan-disease therapy entering the Indian market. Servier is expected to price the drug lower than its US and European counterparts to support affordability.
Servier India, the Indian subsidiary of the France-based healthcare group Servier, said the treatment is approved for patients aged 12 years and above who have slow-growing IDH-mutant gliomas, cancers that can significantly affect everyday life and often appear in people in their 20s, 30s and 40s. In India, an estimated 4,500 people are diagnosed with these tumours each year, yet treatment choices have barely changed for more than two decades.
Vorasidenib works differently from chemotherapy or radiotherapy. Instead of damaging both healthy and cancerous cells, it blocks a faulty enzyme caused by an IDH1 or IDH2 mutation — the driver behind tumour growth. By targeting this mutation directly, the medicine aims to slow disease progression and help patients maintain a better quality of life during long treatment journeys.
“Vorasidenib marks an important step forward for patients who have had very few choices for many years,” said Aurelien Breton, Managing Director of Servier India. He added that Servier is expanding its precision-oncology portfolio in India, where it also markets Tibsovo®, a targeted treatment for IDH1-mutated blood and bile-duct cancers.
Servier said it will work with clinicians and hospitals to support appropriate use of the therapy as it becomes available in the country. Globally, Vorasidenib has been recognised for its scientific contribution and recently received the 2025 Prix Galien USA Award for Best Product for Orphan/Rare Diseases.
Anagha Padhye, Director of Regulatory Affairs and Pharmacovigilance, said the approval reflects close collaboration with CDSCO. “This approval enables access to a much-needed therapy for patients with Grade 2 IDH-mutant glioma, and we remain committed to ensuring its timely availability,” she said. The company said the approval highlights the increasing availability of targeted therapies in India at a time when more clinicians are seeking treatments that offer better control of disease with fewer long-term side effects.
Dr Pranav Sopory, Medical and Patient Affairs Director at Servier India, said Vorasidenib demonstrates the growing role of personalised medicine. “The treatment targets specific genetic mutations affecting typically young adults and has the potential to help preserve their quality of life, allowing patients to spend more meaningful time with loved ones,” he said.
India will get its first major treatment for a rare form of brain cancer in more than 25 years, with the drug regulator clearing Servier India to launch Vorasidenib (Voranigo), a targeted therapy for patients with Grade 2 IDH-mutant glioma.
The Central Drugs Standard Control Organisation (CDSCO) granted approval after the medicine was cleared by the US Food and Drug Administration in August 2024 and by European regulators in September 2025 an unusually quick turnaround for an orphan-disease therapy entering the Indian market. Servier is expected to price the drug lower than its US and European counterparts to support affordability.
Servier India, the Indian subsidiary of the France-based healthcare group Servier, said the treatment is approved for patients aged 12 years and above who have slow-growing IDH-mutant gliomas, cancers that can significantly affect everyday life and often appear in people in their 20s, 30s and 40s. In India, an estimated 4,500 people are diagnosed with these tumours each year, yet treatment choices have barely changed for more than two decades.
Vorasidenib works differently from chemotherapy or radiotherapy. Instead of damaging both healthy and cancerous cells, it blocks a faulty enzyme caused by an IDH1 or IDH2 mutation — the driver behind tumour growth. By targeting this mutation directly, the medicine aims to slow disease progression and help patients maintain a better quality of life during long treatment journeys.
“Vorasidenib marks an important step forward for patients who have had very few choices for many years,” said Aurelien Breton, Managing Director of Servier India. He added that Servier is expanding its precision-oncology portfolio in India, where it also markets Tibsovo®, a targeted treatment for IDH1-mutated blood and bile-duct cancers.
Servier said it will work with clinicians and hospitals to support appropriate use of the therapy as it becomes available in the country. Globally, Vorasidenib has been recognised for its scientific contribution and recently received the 2025 Prix Galien USA Award for Best Product for Orphan/Rare Diseases.
Anagha Padhye, Director of Regulatory Affairs and Pharmacovigilance, said the approval reflects close collaboration with CDSCO. “This approval enables access to a much-needed therapy for patients with Grade 2 IDH-mutant glioma, and we remain committed to ensuring its timely availability,” she said. The company said the approval highlights the increasing availability of targeted therapies in India at a time when more clinicians are seeking treatments that offer better control of disease with fewer long-term side effects.
Dr Pranav Sopory, Medical and Patient Affairs Director at Servier India, said Vorasidenib demonstrates the growing role of personalised medicine. “The treatment targets specific genetic mutations affecting typically young adults and has the potential to help preserve their quality of life, allowing patients to spend more meaningful time with loved ones,” he said.