CDSCO Panel Recommends Approval for Vorasidenib with Phase-III Waiver, Mandates Phase-IV Trial in India

Published On 2025-08-03 06:30 GMT   |   Update On 2025-08-03 06:31 GMT
Advertisement

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.

Advertisement

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.

Also Read: Eris Gets CDSCO Panel Nod To Dapagliflozin-Bisoprolol-Sacubitril Valsartan Combo Kit, Phase IV Trial Mandated

Tags:    

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Similar News