Servier India, a subsidiary of the French pharmaceutical group Servier, has received marketing authorisation from the Central Drugs Standard Control Organisation (CDSCO) for Vorasidenib (Voranigo). The oral therapy is approved for adults and paediatric patients aged 12 years and older with Grade 2 gliomas, including astrocytoma or oligodendroglioma, with an IDH1 or IDH2 mutation following surgery, which includes biopsy, subtotal resection, or gross total resection.
Vorasidenib is a targeted therapy that inhibits the mutant IDH enzyme responsible for tumour growth and spread. This mechanism delays tumour progression and supports patients in maintaining quality of life. The burden of rare IDH-mutated Grade 2 gliomas is estimated at about 4,500 patients per year in India, with most cases occurring in young adults. For more than 20 years, patients with these cancers have had limited precision-based therapeutic options.
Aurelien Breton, Managing Director, Servier India, said, “India is a key part of Servier’s global journey in advancing cancer care. Vorasidenib marks a significant breakthrough directly addressing a critical unmet need in rare neuro-oncology. Alongside this, Tibsovo, our targeted therapy for IDH1-mutated Acute Myeloid Leukemia and Cholangiocarcinoma, is available for patients — further expanding access to precision oncology treatments across India. With the introduction of such innovative therapies, we continue to work towards improving patient outcomes throughout India.”
Anagha Padhye, Director – Regulatory Affairs and Pharmacovigilance, Servier India, said, “Our team is proud to achieve this important regulatory milestone for Vorasidenib in India. This approval enables the availability of a therapeutic option for patients with Grade 2 IDH-mutant glioma and we remain committed to working closely with health authorities to ensure Voranigo’s timely access.”
Dr Pranav Sopory, Medical and Patient Affairs Director, Servier India, said, “Vorasidenib exemplifies the promise of precision medicine, offering patients a treatment that targets specific genetic mutations affecting typically young adults. The treatment has the potential to help preserve their quality of life—allowing patients spend more meaningful time with loved ones. We remain committed to collaborating with the medical community through scientific exchange and education in the field of neuro-oncology.”
Pratima Tripathi, Commercial Director – Oncology, Servier India, said, “The introduction of Vorasidenib accelerates Servier’s impact in India’s oncology market, expanding our portfolio of innovative therapies. Building on the success of our launches earlier this year, we will continue to support scientific awareness and responsible dissemination of information to healthcare professionals.”
Globally, Voranigo (Vorasidenib) has been recognised for its scientific excellence, having received The Galien Foundation’s 2025 Prix Galien USA Award for Best Product for Orphan/Rare Diseases. The Prix Galien Award is an independent distinction that acknowledges products introduced in the public market and recognises achievements in the pharmaceutical, biotechnology, medical technology, and digital health industries.