MSD Pharmaceutical Gets CDSCO Panel Nod To study MK-1084

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2024-12-17 12:30 GMT | Update On 2024-12-17 12:30 GMT

New Delhi: MSD Pharmaceutical has got approval from the Subject Expert Committee SEC functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the phase 3 clinical study of the anti-cancer drug MK-1084.

This came after MSD Pharmaceutical presented phase 3 clinical study protocol no. MK-1084-004 version 00 dated 15 December 2023.

However, this nod is subject to the condition that the number of subjects shall be increased up to 50. Furthermore, the expert panel stated that more geographically distributed government sites shall be included in the study.

MK-1084, a selective KRAS G12C inhibitor, has demonstrated promising antitumor activity in preclinical studies. KRAS G12C inhibitors can slow tumor growth via attenuation of the KRAS signaling pathway. .

MK-1084 is an orally available drug that targets the KRAS G12C mutant, which is a type of mutation in the KRAS oncogene. KRAS is involved in cell signaling, division, and differentiation, and mutations in KRAS can lead to tumor cell proliferation.

At the recent SEC meeting for Oncology held on 5th December 2024, the expert panel reviewed the phase 3 clinical study protocol no. MK-1084-004 version 00 dated 15 December 2023.

After detailed deliberation, the committee recommended the grant of permission to conduct the trial as presented by the firm with the following condition:

1. The number of subjects shall be increased up to 50.

2. More geographically distributed government sites shall be included in the study.

Also Read: CDSCO panel approves AstraZeneca's Protocol Amendment proposal for Anticancer Drug AZD5305 study

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Dr. Divya Colin

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.

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MSD Pharmaceutical Gets CDSCO Panel Nod To study MK-1084

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