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