Submit AE and SAE Data : CDSCO Panel Tells MSN Pharmaceuticals on Anti-cancer Drug MK-1084
New Delhi: Reviewing phase 3 clinical study protocol of the anti-cancer drug MK-1084, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined MSD Pharmaceuticals to submit details of AE (adverse event) and SAE (serious adverse event) data for further review.
This came after MSD Pharmaceuticals presented phase 3 clinical study protocol no. MK-1084-004 version 00 dated 15 December 2023.
MK-1084 is an investigational, potent, and specific KRAS G12C covalent inhibitor. Mutations in KRAS are among the most prevalent mutations found in cancer, occurring with high frequency in non-small cell lung cancer, and pancreatic, urogenital, and colorectal cancers. The KRAS G12C mutation is the most frequently observed KRAS mutation in patients, occurring in approximately 14% of non-small cell lung cancers (adenocarcinoma).
MK-1084 is an orally available inhibitor of the oncogenic KRAS substitution mutation G12C, with potential antineoplastic activity. Upon oral administration, KRAS G12C inhibitor MK-1084 selectively targets the KRAS G12C mutant and inhibits KRAS G12C-mediated signaling.
MK-1084 exhibits anticancer activity and can be used either alone or in combination with pembrolizumab for cancer research.
At the recent SEC meeting held on July 9, 2024, the expert panel reviewed phase 3 clinical study protocol no. MK-1084-004 version 00 dated 15 December 2023 presented by MSD Pharmaceuticals.
After detailed deliberation, the committee opined that the firm should submit details of AE (adverse event) and SAE (serious adverse event) data for further review by the committee.
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