Novartis Gets CDSCO Panel Nod to Study anti-cancer drug Ribociclib
New Delhi: The drug major Novartis has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase IV clinical study of the anti-cancer drug Ribociclib (LEE011).
This came after Novartis presented Phase IV clinical study protocol No. CLEE011A2412B version number 00 dated 19 Nov 2021. This is a post-trial access roll-over study to allow access to ribociclib (LEE011) for patients who are on ribociclib treatment in a Novartis-sponsored study.
Ribociclib is used in combination with letrozole in patients with hormone receptor (HR)-positive, HER-2 negative advanced or metastatic breast cancer. It is also used together with fulvestrant to treat HR-positive, HER-2-negative advanced or metastatic breast cancer in postmenopausal women or in men.
Ribociclib is a selective cyclin-dependent kinase inhibitor, a class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated, can enable cancer cells to grow and divide too quickly.
At the recent SEC meeting for Oncology held on the 3rd and 4th of April 2024, the expert panel reviewed the Phase IV clinical study protocol No.CLEE011A2412B version number 00 dated 19 Nov 2021.
After detailed deliberation, the committee recommended a grant of permission to conduct the trial.
