CDSCO Panel Approves AstraZeneca’s Protocol Amendment Proposal to Study anti-cancer Drug Capivasertib

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has approved AstraZeneca’s protocol amendment proposal to study the anti-cancer drug Capivasertib.

This came after AstraZeneca presented protocol amendment 5, version 6.0 dated 05 March 2024 protocol no. D361DC00001.

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 the 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 held on July 9, 2024, the expert panel reviewed protocol amendment 5, version 6.0 dated 05 March 2024 protocol no. D361DC00001.

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

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