CDSCO Panel Approves Novartis Protocol Amendment Proposal to study Ribociclib

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major Novartis' protocol amendment proposal for the clinical trial protocol titled, "A post-trial access roll-over study to allow access to ribociclib (LEE011) for patients who are on ribociclib treatment in Novartis-sponsored study.”

This came after Novartis presented protocol amendment version 01 dated 01 December 2023 protocol no. CLEE011A2412B.

LEE011 (ribociclib) is a selective cyclin dependent kinase inhibitor, a new class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin dependent kinase 4 and 6 (CDK4/6).

Ribociclib is a selective inhibitor of CDK4/6 that binds to the ATP-binding sites of these proteins. This blocks the CDK4/6-cyclin D-Rb-E2F axis, which reverses uncontrolled cell proliferation and tumor growth.

At the recent SEC meeting for Oncology held on 9th October 2024, the expert panel reviewed the protocol amendment version 01 dated 01 December 2023 protocol no. CLEE011A2412B

After detailed deliberation, the committee recommended the approval of the protocol amendment as presented by the firm.

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