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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