CDSCO panel approves AstraZeneca's Protocol Amendment proposal for Anticancer Drug AZD5305 study

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-12-15T17:30:50+05:30 | Updated On 15 Dec 2024 5:30 PM IST

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major AstraZeneca's proposal for the protocol amendment of the clinical trial titled "A randomised 2 cohort double blind placebo controlled phase III study of AZD5305 in combination with physicians choice new hormonal agents in patients with HRRm and non-HRRm metastatic castration sensitive prostate cancer (EvoPAR-Prostate01)"

This came after the firm presented protocol amendment version 4.0 dated 23 May 2024 protocol no.n D9723C00001. The intention of the study is to demonstrate superiority of Saruparib (AZD5305) + physician’s choice NHA relative to placebo + physician’s choice NHA by assessment of radiographic progression-free survival (rPFS) in participants with Metastatic Castration-Sensitive Prostate Cancer (mCSPC).

AZD5305 is a type of targeted cancer drug called a PARP inhibitor. PARP is a protein found in cells; it stands for poly-ADP ribose polymerase. Poly(ADP-ribose) polymerase (PARP) is an enzyme that helps repair DNA damage. PARP inhibitors are drugs that try to keep cancer cells from repairing damaged tumor DNA, leading to tumor cell death.

AZD5305 potently and selectively inhibits PARP1 resulting in excellent antiproliferative activity and unprecedented selectivity for DNA repair deficient versus proficient cells.

At the recent SEC meeting for Oncology held on 5th December 2024, the expert panel reviewed the proposal presented by the drug major AstraZeneca

After detailed deliberation, the committee recommended the approval of the protocol amendment as presented by the firm.

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cdscoAZD5305astrazenecaanticancer drugprostate cancer

Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751