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  • CDSCO Panel Approves...

CDSCO Panel Approves Novartis Protocol Amendment Proposal To Study Ruxolitinib and Panobinostat

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-06-30T17:30:43+05:30  |  Updated On 30 Jun 2024 5:30 PM IST
Novartis to acquire kidney disease drug maker Regulus Therapeutics for up to 1.7 billion
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New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the protocol amendment proposal presented by the drug major Novartis for the clinical trial protocol titled "Open Label, Multi-Center, Phase IV Study of Ruxolitinib or Ruxolitinib and Panobinostat Combination, for Patients Who Have Completed Prior Global Novartis or Incyte Sponsored Studies".

This came after the firm presented protocol amendment version 05 dated 12.01.2024 protocol no.CINC424A2X01B. This is a long term safety study for patients that have been treated with either ruxolitinib or a combination of ruxolitinib with panobinostat, on a Novartis or Incyte sponsored study, who have been judged by the study Investigator to benefit from ongoing treatment.

Ruxolitinib is a medication used to manage and treat myelofibrosis, polycythemia vera, and steroid-refractory acute graft-versus-host disease. It is in the Janus Kinase inhibitor class of medications. Ruxolitinib falls under the drug class known as Janus kinase inhibitors (JAK Inhibitors). It is an inhibitor of the JAK1 and JAK2 protein kinases and works by competitively inhibiting the ATP-binding catalytic site on JAK1 and JAK2.

Panobinostat is a potent inhibitor of histone deacetylase, which is responsible for the regulation of gene transcription, cellular differentiation, cell-cycle progression, and apoptosis. The inhibition of histone deacetylase prevents the deacetylation of histone and nonhistone proteins. Panobinostat is a chemotherapy medication that stops cancer cells from growing. It treats multiple myeloma. This is a rare type of blood cancer that affects many parts of your body.

At the SEC meeting for Oncology held on 5th and 6th June 2024, the expert panel reviewed protocol amendment version 05 dated 12.01.2024 protocol no.CINC424A2X01B presented by the drug major Novartis.

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

Also Read:Zydus Life Science Gets CDSCO Panel Nod To Manufacture and Market Anti-cancer Drug Nelarabine

cdscoNovartisRuxolitinibPanobinostatprotocol amendment
Dr. Divya Colin
Dr. Divya Colin

    Doctor of Pharmacy

    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.

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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