Indian Regulator Recommends Dr. Reddy’s for Olutasidenib Capsules, Waives Phase III Trial

In a significant step towards expanding the availability of cancer treatments in India, the Subject Expert Committee (SEC) on Oncology has recommended that Dr. Reddy’s Laboratories be granted permission to import and market Olutasidenib Capsules 150 mg. This recommendation was made during the SEC’s 25th meeting on August 6, 2025, at the CDSCO headquarters in New Delhi.

Addressing an Unmet Medical Need

Dr. Reddy’s Laboratories presented their proposal for the drug, which is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a susceptible isocitrate dehydrogenase-1 (IDH1) mutation. The company provided comprehensive global clinical data on the drug’s safety and efficacy. The SEC noted that Olutasidenib is already approved in the United States and Europe, highlighting a clear international precedent for its use. The committee’s decision was also influenced by the recognized unmet medical need for this specific treatment in India.

Conditions for Approval

While the SEC recommended a waiver for the local Phase III clinical trial, it attached two important conditions to its approval:

Phase IV Clinical Trial: Dr. Reddy’s must conduct a Phase IV clinical trial in India. The firm is required to submit the protocol for this trial for the committee’s review within three months of the drug’s approval.
Special Side-Effect Warning: The SEC mandated that the prescribing information for Olutasidenib Capsules must specifically mention differentiation syndrome as a side-effect of special interest. Dr. Reddy’s is tasked with submitting a revised prescribing information to the CDSCO that prominently highlights this warning.

This recommendation marks a crucial step in bringing a new therapeutic option to Indian patients suffering from a specific, difficult-to-treat form of leukemia.