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

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.

Also Read: CDSCO approves India's 1st robotic system SSI Mantra for telesurgery, teleproctoring