Expansion of warning statement may be considered after submission of first year PSUR data: CDSCO panel on AstraZeneca's anticancer drug

Tremelimumab is an anti-CTLA-4 antibody used to treat unresectable hepatocellular carcinoma in combination with durvalumab.

Tremelimumab is a fully human IgG2 monoclonal antibody directed against cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4). CTLA-4 is a cell surface receptor expressed on activated T cells to act as a negative regulator for T cells. By binding to CTLA-4, tremelimumab enhances T cell-mediated killing of tumours and reduces tumour growth. Because CTLA-4 is an immune checkpoint that plays a vital role in regulating T cell-mediated immune responses, tremelimumab is considered an immune checkpoint inhibitor, which is an emerging cancer immunotherapy drug class.

At the recent SEC meeting on the 5th and 6th of June 2024, the expert panel reviewed the proposal for expansion of the warning statement for the approved drug Tremelimumab Concentrate for Solution for infusion 20 mg/ml (25 mg/1.25 ml and 300 mg/15 ml presentations) in single-dose vials from “To be sold by retail on the prescription of a registered oncologist only” to “To be sold by retail on the prescription of a registered oncologist/ gastroenterologist only”.

After detailed deliberation, the committee recommended,

"The proposal for expansion of the warning statement may be considered after submission of the first-year PSUR data and subsequent review of the same by the committee."