CDSCO Panel Approves IQVIA's Protocol Amendment Proposal For Anti-cancer Drug Xevinapant

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-03-27T05:30:40+05:30 | Updated On 27 March 2024 5:30 AM IST

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major IQVIA's proposal for the protocol amendment of the anti-cancer drug Xevinapant study.

This came after the firm presented protocol amendment version 6.0 dated 18 October 2023 protocol No. MS202359_0002.

Xevinapant is a first-in-class, orally available antagonist or inhibitor of apoptosis proteins (IAP) with the potential to enhance the anticancer activity of cisplatin and radiotherapy.

Xevinapant was initially investigated in patients with stage III or IVA/B unresectable, locally advanced squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx, and more than a 10-pack-year smoking history.

Xevinapant mode of action through blocking cIAP1/2 and XIAP: (A) In the intrinsic apoptotic pathway, cytochrome c is released from the mitochondria into the cytosol in response to apoptotic stimuli that cause intracellular stress or DNA damage.

At the recent SEC meeting for Oncology on 5th March 2024, the expert panel reviewed the proposal protocol amendment version 6.0 dated 18 October 2023 protocol No. MS202359_0002.

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

Also Read: CDSCO Panel Approves AstraZeneca's Protocol Amendment Proposal For Anti-cancer Drug Osimertinib

cdscoIQVIAXevinapantprotocol amendment

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