CDSCO Panel Flags Ethnic Variability, Seeks More Data from Takeda for Fruquintinib Hard Capsule Approval

New Delhi: Following a detailed evaluation of global Phase III clinical data and safety findings of Fruquintinib 1 mg and 5 mg Hard capsule, the Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control Organization (CDSCO) has opined that Takeda Biopharmaceuticals India should provide a comprehensive presentation substantiating the claim with respect to no ethnic variability in the Indian population and addressing the safety profile of the drug.

This came after the firm presented the proposal for a grant of permission for the import and marketing of the drug Fruquintinib Capsules 1 mg and 5 mg along with justification for a local Phase III Clinical Trial waiver before the committee.

Fruquintinib is a novel small-molecule anti-VEGFR that targets VEGFR-1,-2, and -3 to inhibit angiogenesis. Tumor angiogenesis is one of the most critical biological processes for increasing oxygen and nutrient supply to cancer cells, and the VEGF/VEGFR pathway is one of the most critical pathways for this phenomenon.

Fruquintinib is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy.

At the recent SEC (Oncology) meeting held on 14th October 2025, the expert panel scrutinized the company’s justification regarding the applicability of foreign clinical data to the Indian population.

The committee reviewed two Phase III clinical trial data submitted by the firm conducted in other countries.

After detailed deliberation, the committee opined that the firm should provide a comprehensive presentation substantiating the claim with respect to no ethnic variability in the Indian population and addressing the safety profile of the drug.

Further, the committee recommended that the firm should conduct a well-structured Phase IV clinical trial in Indian patients to evaluate the safety concerns with the molecule.

In this regard, the expert panel opined that firm should submit Phase IV CT protocol to CDSCO for further review by the committee