Zydus Told To Conduct Phase III Trial in India for Lurbinectedin Injection, BE Study Waived

Lurbinectedin is a selective inhibitor of oncogenic transcription, approved in several countries including the United States, primarily for the treatment of relapsed small cell lung cancer (SCLC). It functions by inhibiting RNA polymerase II, leading to DNA strand breaks and subsequent cancer cell death. Given the global approvals and its role in treating aggressive cancers, Zydus had proposed introducing the drug in India without additional local studies.

However, after reviewing the submitted data and deliberating on the request, the SEC agreed to waive the requirement for a bioequivalence study, but did not approve a waiver for clinical trials. Emphasizing the importance of Indian population-specific data, the committee recommended that the company conduct a Phase III clinical trial locally.

According to the minutes of the meeting,

“After detailed deliberation, the committee recommended for waiver of Bioequivalence study and opined that firm should conduct Phase III clinical trial in Indian population. Accordingly, the firm should submit Phase III Clinical Trial protocol to CDSCO for further review by the committee.”

The company has been asked to submit the detailed Phase III clinical trial protocol to CDSCO for further review and approval before commencing the trial.