Servier India receives positive recommendation from SEC to import and market Vorasidenib tablets 10 mg & 40 mg for the treatment of adults and adolescents with grade 2 IDH-mutant diffuse glioma, a type of brain cancer

• Granted waiver for local Phase-III clinical trials, clearing way for import and market authorization in India.
• Servier India was recommended to conduct Phase IV clinical trial for which the protocol to be submitted to CDSCO within 3 months of approval of the drug for review by the committee.

Mumbai, India, August 06, 2025 – Servier India, a research-driven pharmaceutical organization focused on oncology and specialty therapeutic areas in India, has received a positive recommendation from the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) to import and market Vorasidenib Tablets 10 mg and 40 mg in India. Vorasidenib is a therapy for treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma (brain tumors) with a susceptible isocitrate dehydrogenase-1 (IDH1) or isocitrate dehydrogenase-2 (IDH2) mutation following surgery including biopsy, sub-total resection, or gross total resection. Gliomas are types of brain cancer that can hinder normal brain function and cause a variety of symptoms.

The committee granted a waiver for local Phase-III clinical trials, acknowledging the drug’s orphan drug status in other countries and the unmet medical needs in India. The committee further recommended that Servier should conduct Phase IV clinical trial on Indian patients for which the protocol should be submitted to CDSCO within 3 months of approval of the drug for review by the committee.

Anagha Padhye, Director- Regulatory Affairs and Pharmacovigilance – Servier India, said, “We appreciate the Subject Expert Committee’s positive recommendation, which reflects the recognition of the identified unmet medical needs of patients with challenging brain tumors in India. Our team is committed to ensuring a smooth regulatory process including post-approval study to emphasize the safety and effectiveness of this therapy for Indian patients.”

“We are pleased by the Subject Expert Committee’s positive recommendation for Vorasidenib 10 mg and 40 mg tablets, , based on global clinical data and regulatory considerations relevant to Indian patients. We remain committed to upholding the highest standards of patient safety and clinical excellence by conducting Phase IV trials and facilitating appropriate medical access in line with regulatory guidance and medical need.” Said, Dr. Pranav Sopory, Medical and Patient Affairs Director, Servier India.

Servier India remains committed to contributing to the evolving landscape of evidence-based oncology care by introducing such advanced therapies that improve clinical outcomes and enhance the quality of life of cancer patients.

About Glioma

Gliomas are tumors that arise from glial or precursor cells within the central nervous system (CNS). The 2021 World Health Organization (WHO) classification recognizes four general groups of gliomas, one of which is adult-type diffuse gliomas. These diffuse gliomas are the most common primary malignant brain tumors in adults. The pathogenesis and prognosis of these tumors are tightly linked to mutations (or lack thereof) in the metabolic enzyme isocitrate dehydrogenase (IDH), and molecular testing is required for proper diagnosis. As of 2021, adult-type diffuse gliomas are sub-divided into only three categories:

• Astrocytoma, IDH-mutant (CNS WHO grades 2-4)

• Oligodendroglioma, IDH-mutant and1p19q-codeleted

For more information on Glioma: https://servier.com/en/newsroom/folders/glioma-aggressive-brain-tumor/

More information on Vorasidenib:

Vorasidenib was approved in 2024 in the United States by the Food and Drug Administration (FDA), and has been granted marketing authorization in Canada, Australia, Israel, the United Arab Emirates, Saudi Arabia, Macau and Switzerland.

Disclaimer: This press release is intended solely to communicate regulatory developments and publicly available medical information. Any reference to “Vorasidenib” is for informational purposes only and does not constitute advertisement, promotion of the product.

About Servier India         

Servier India has been committed for over three decades to delivering innovative pharmaceutical solutions that improve the lives of patients and their families across India. Established in 1985 as an affiliate of the leading independent French pharmaceutical Servier Group, the company focuses on therapeutic areas such as Cardiometabolism, , Venous Diseases, and Oncology. Servier India has a strong pan-India presence and a dedicated workforce of around 580 that strives to address critical healthcare challenges with passion and purpose.

As part of Servier group operating in over 150 countries, Servier India inherits a rich legacy of scientific excellence and patient-centric innovation. Globally, Servier invests heavily in research and development, focusing on our key therapeutic areas.