CDSCO Panel Approves Eli Lilly's protocol amendment proposal for Adjuvant Imlunestrant vs Standard Adjuvant study

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-04-21T17:15:40+05:30 | Updated On 21 April 2024 5:15 PM IST

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major Eli Lilly's protocol amendment proposal for Adjuvant Imlunestrant vs Standard Adjuvant study.

This came after Eli Lilly presented protocol amendment (d) dated 05 Feb 2024 and India ICF V7.0 dated 21 Feb 2024 protocol No. J2J-MC-JZLH.

Imlunestrant specifically targets and binds to the estrogen receptor (ER) and induces a conformational change that results in ER degradation. This prevents ER-mediated signaling and inhibits both the growth and survival of ER-expressing cancer cells.

Imlunestrant features pure antagonistic properties that cause continuous inhibition of ER-dependent gene transcription and cell growth.

At the recent SEC meeting for Oncology held on the 3rd and 4th of April 2024, the expert panel reviewed the proposal for the protocol amendment of the Adjuvant Imlunestrant vs Standard Adjuvant study presented by the drug major Eli Lilly.

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

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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