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

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-07-28T18:15:55+05:30 | Updated On 28 July 2024 6:15 PM IST

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.

Also Read: CDSCO Panel Approves Johnson and Johnson's Protocol Amendment Proposal to Study JNJ-77242113

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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.

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751