New Delhi: Reviewing the justification for waiver of the Phase III clinical trial of the anti-cancer drug Abiraterone Acetate presented by BDR Pharmaceutical Int, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has reiterated earlier recommendations to conduct Phase III clinical trial.
This came after BDR Pharmaceutical Int presented justification for waiver of the Phase III clinical trial before the committee.
The firm informed that the proposed drug formulation Abiraterone Acetate Oral Suspension 1000mg/5ml has not yet been approved anywhere.
The committee opined that the proposed formulation does not come under clinical trial waiver criteria i.e. unmet medical need, orphan drug status, or indicated serious life-threatening disease.
Abiraterone is a potent, irreversible, and selective inhibitor of 17 αhydroxylase/C17,20-lyase (CYP17), an enzyme expressed in testicular, adrenal, and prostatic tumor tissues, to regulate androgen biosynthesis.
At the recent SEC meeting for Oncology on 19th and 20th March 2024, the expert panel reviewed the justification for waiver of the Phase III clinical trial of the anti-cancer drug Abiraterone Acetate.
After detailed deliberation, the Committee reiterated their earlier recommendations to conduct a Phase III clinical trial.
Accordingly, the expert panel suggested that the firm should submit the Phase III clinical trial protocol to CDSCO for further review by the committee.
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