AstraZeneca gets CDSCO panel nod to study anti-cancer drug Capivasertib

Written by Dr. Divya Colin Published On 2023-12-17T18:00:57+05:30 | Updated On 18 Dec 2023 7:19 AM IST

AstraZeneca gets CDSCO panel nod to study anti-cancer drug Capivasertib

New Delhi: The drug major AstraZeneca has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the phase 1b/III clinical study of the anti-cancer drug Capivasertib film-coated tablet 160mg or 200mg.

However, this approval is subject to a condition that the Phase-Ib part of the study will not be applicable in India.

This came after the drug major AstraZeneca presented Phase1b/III Clinical Study Protocol no. D361DC00001.

This Phase Ib/III study aims to evaluate the efficacy, safety, and degree of the added benefit of capivasertib combined with CDK4/6i and fulvestrant in participants with locally advanced (inoperable) or metastatic HR+/HER2- breast cancer.

Capivasertib is a serine/threonine kinase inhibitor used to treat hormone receptor-positive, HER2-negative, locally advanced, or metastatic breast cancer.

Capivasertib is an inhibitor of all 3 isoforms of serine/threonine kinase AKT (AKT1, AKT2, and AKT3) and inhibits phosphorylation of downstream AKT substrates. AKT activation in tumors is a result of activation of upstream signaling pathways, mutations in AKT1, loss of phosphatase and tensin homolog (PTEN) function, and mutations in the catalytic subunit alpha of phosphatidylinositol 3-kinase (PIK3CA).

At the recent SEC meeting for Oncology and Hematology held on 29th and 30th November 2023, the expert panel reviewed the Phase 1b/III clinical study protocol of the anti-cancer drug Capivasertib (AZD5363) film-coated tablet presented by AstraZeneca.

After detailed deliberation, the committee recommended for grant of permission to conduct the trial as presented by the firm subject to the condition that Phase-Ib part of the study will not be applicable in India.

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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.