CDSCO Panel Recommends Approval for Vorasidenib with Phase-III Waiver, Mandates Phase-IV Trial in India
New Delhi: In response to a proposal by Servier India Pvt. Ltd. seeking approval to import and market the anti-cancer drug Vorasidenib Tablets 10 mg and 40 mg, the Subject Expert Committee (SEC) on Oncology under the Central Drugs Standard Control Organization (CDSCO) has recommended the grant of marketing permission with a waiver of local Phase-III clinical trials, subject to post-marketing commitments.
The proposal was reviewed during the SEC meeting held on 17th July 2025, where the company sought approval for the drug along with exemption from conducting local Phase-III clinical trials. The committee noted that Vorasidenib has already been granted orphan drug status in other countries, and that the prescribing information for the Indian product was in line with regulatory approvals abroad.
Vorasidenib is a dual isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor, indicated for the treatment of adult and pediatric patients (aged 12 years and older) with Grade 2 astrocytoma or oligodendroglioma harboring IDH1 or IDH2 mutations, following surgery including biopsy, subtotal resection, or gross total resection.
The firm assured the committee that it will conduct a Phase-IV clinical trial in Indian patients and provide post-trial access to enrolled subjects.
After detailed deliberation, the committee acknowledged the unmet medical need for the proposed indications in India. Accordingly, it recommended the grant of permission to import and market Vorasidenib Tablets 10 mg and 40 mg, with a waiver of local Phase-III clinical trials.
“The committee recommended for the grant of permission to manufacture and market of the drug Vorasidenib Tablets 10 mg & 40 mg with local Phase III clinical trial waiver. Further, the committee recommended that the firm should conduct Phase IV clinical trial for which the protocol should be submitted to CDSCO within 3 months of approval of the drug for review by the committee,” the SEC noted in its official recommendation.
