CDSCO Panel Approves IQVIA's Protocol Amendment Proposal For Anti-cancer Drug Xevinapant
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
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.