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.

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