CDSCO Panel Approves AstraZeneca’s Protocol Amendment Proposal to Study Capivasertib Plus Abiraterone
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 amendment of protocol for the clinical study ” A Phase III Double-Blind, Randomised, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib+Abiraterone Versus Placebo+Abiraterone as Treatment for Patients with DeNovo Metastatic Hormone-Sensitive Prostate Cancer Characterised by PTEN deficiency.”
This came after the drug major AstraZeneca presented protocol amendment version 3.0 dated 01/Sep/2023 protocol no. D361BC00001.
Capivasertib is an investigational oral treatment currently in Phase III trials for the treatment of multiple subtypes of breast cancer, and prostate cancer and a Phase II trial for haematologic malignancies. Capivasertib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells.
Abiraterone belongs to a class of drugs known as anti-androgens (anti-testosterone). Abiraterone is used in combination with prednisone to treat a certain type of prostate cancer that has spread to other parts of the body. Abiraterone is in a class of medications called androgen biosynthesis inhibitors. It works by decreasing the amount of certain hormones in the body.
At the recent SEC meeting for Oncology held on the 23rd and 24th of January 2023, the expert panel reviewed the proposal presented by the drug major AstraZeneca for the protocol amendment of the FDC Capivasertib plus Abiraterone.
After detailed deliberation, the committee recommended approval of the protocol amendment as presented by the firm.
