India's Central Drugs Standard Control Organisation (CDSCO) panel has recommended approval for vorasidenib, a dual IDH inhibitor for treating specific brain tumors, marking a significant development for patients with IDH-mutant gliomas in the country. The Subject Expert Committee (SEC) reviewed the proposal during its meeting on July 17, 2025, where the company sought approval along with exemption from conducting local Phase-III clinical trials.
Regulatory Decision and Rationale
The committee recommended granting permission to import and market vorasidenib tablets in 10 mg and 40 mg strengths with a waiver of local Phase-III clinical trials. This decision was based on several key factors, including the drug's orphan drug status in other countries and the alignment of prescribing information for the Indian product with regulatory approvals abroad.
"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," the SEC noted in its official recommendation.
Drug Profile and Indication
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. The treatment is specifically for patients following surgery, including biopsy, subtotal resection, or gross total resection.
Post-Marketing Requirements
Despite the Phase-III waiver, the committee has mandated specific post-marketing commitments. The firm has assured the committee that it will conduct a Phase-IV clinical trial in Indian patients and provide post-trial access to enrolled subjects. The protocol for this Phase-IV study must be submitted to CDSCO within 3 months of drug approval for committee review.
Addressing Unmet Medical Need
After detailed deliberation, the committee acknowledged the unmet medical need for the proposed indications in India. This recognition played a crucial role in the decision to grant the Phase-III waiver, allowing faster access to this targeted therapy for patients with IDH-mutant gliomas in the Indian market.
