In its 25th meeting held on 06.08.2025 at CDSCO Headquarters, New Delhi, the Subject Expert Committee (SEC) on Oncology recommended approval for Dr. Reddy’s Laboratories to import and market Olutasidenib Capsules.
US Food and Drug Administration (FDA) approved olutasidenib capsules for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test.
Dr. Reddy’s Laboratories presented the proposal for grant of permission for Import and Marketing of the drug Olutasidenib Capsules 150 mg indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation along with justification for local Phase III Clinical Trial waiver before the committee.
The presented the global clinical data for safety and efficacy of the drug. The committee noted that the drug is approved in the US and Europe. There is unmet medical need in the country.
After detailed deliberation, the committee recommended for the grant of permission for the import and marketing of the drug Olutasidenib Capsules 150 mg with waiver of Phase III clinical trial with condition that the firm should conduct Phase IV clinical trial for which the protocol should be submitted within 3 months of approval of the drug for review by the committee.
The Committee noted that differentiation syndrome should be specifically mentioned as side-effect of special interest in Prescribing Information and accordingly, firm should submit revised prescribing information to CDSCO highlighting the said warning.
