J&J Gets CDSCO Panel Nod to study anticancer drug Cetrelimab
New Delhi: Pharmaceutical major Johnson and Johnson has got the green signal from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct the Phase III clinical trial (CT) of the anti-cancer drug Cetrelimab.
This came after the firm presented the proposal for Phase III clinical trial vide protocol no. 17000139BLC3002, amendment 1, dated 06-Dec-2022 before the committee.
Cetrelimab is under development for the treatment of metastatic or surgically unresectable urothelial cancer, chronic hepatitis B, muscle-invasive bladder cancer (MIBC), metastatic castration-resistant prostate cancer (second line and third line) advanced cancers such as colorectal cancer, non-small-cel
Cetrelimab works by trying to stimulate the immune system to attack prostate cancer by blocking a protein called PD-1. Giving apalutamide and cetrelimab together may cause the tumour to stop growing or grow at a slower rate in patients with prostate cancer.
Cetrelimab binds to PD-1 and inhibits the interaction with its ligands, programmed cell death 1 ligand 1 (PD-L1, PD-1L1) and PD-1 ligand 2 (PD-L2, PD-1L2).
At the recent SEC meeting for Oncology and Hematology held on the 30th of May 2023, the expert panel reviewed the proposal presented by Johnson and Johnson for Phase III clinical trial vide protocol no. 17000139BLC3002, amendment 1, dated 06-Dec-2022.
After detailed deliberation, the committee recommended the grant of permission for the conduct of the proposed Phase III clinical trial as presented by the firm.
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