Dr Reddy's Secures CDSCO Panel Approval to Import, Market Olutasidenib for AML
New Delhi: In a significant development, the pharmaceutical major, Dr. Reddy's Laboratories, has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) to import and market 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 with a waiver of the Phase III Clinical Trial.
However, this nod is subject to the condition that Dr. Reddy’s Laboratories should conduct a Phase IV clinical trial for which the protocol should be submitted within 3 months of approval of the drug for review by the committee.
Furthermore, the expert panel noted that differentiation syndrome should be specifically mentioned as a side effect of special interest in prescribing information. In accordance with this, the committee suggested that the firm should submit revised prescribing information to CDSCO highlighting the said warning.
This came as the firm presented the proposal for a grant of permission for the 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 a local Phase III clinical trial waiver before the committee.
In addition, the firm presented the global clinical data for safety and efficacy of the drug.
Olutasidenib is a selective and potent isocitrate dehydrogenase-1 (IDH1) inhibitor approved by the FDA in December 2022. It is indicated for the treatment of relapsed or refractory acute myeloid leukemia (AML) in patients with a susceptible IDH1 mutation as determined by an FDA-approved test.
IDH1 mutations are common in different types of cancer, such as gliomas, AML, intrahepatic cholangiocarcinoma, chondrosarcoma, and myelodysplastic syndromes (MDS), and they lead to an increase in 2-hydroxyglutarate (2-HG), a metabolite that participates in tumorigenesis. Olutasidenib inhibits the mutated IDH1 specifically and provides a therapeutic benefit in IDH1-mutated cancers.
At the recent SEC meeting for oncology held on 6th August, 2025, the expert panel reviewed the proposal presented by Dr. Reddy’s Laboratories for the 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 a local Phase III clinical trial waiver.
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 the grant of permission for the import and marketing of the drug Olutasidenib Capsules 150 mg with a waiver of the Phase III clinical trial with the condition that the firm should conduct a Phase IV clinical trial for which the protocol should be submitted within 3 months of approval of the drug for review by the committee.
In addition, the committee noted that differentiation syndrome should be specifically mentioned as a side effect of special interest in Prescribing Information and accordingly, the firm should submit revised prescribing information to CDSCO highlighting the said warning.
