CDSCO Panel Approves Novartis Protocol Amendment Proposal for Ruxolitinib study

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the protocol amendment proposal presented by Novartis to study anticancer drug INC424 (Ruxolitinib).

This came after the firm presented Protocol Amendment Version 06 dated 29 Aug 2024, protocol no. CINC424A2X01B. This is an open-label, multi-center Phase IV roll-over protocol for patients who have completed a prior global Novartis or Incyte-sponsored ruxolitinib (INC424) study or ruxolitinib and panobinostat (LBH589) combination study and are judged by the investigator to benefit from continued treatment.

Ruxolitinib, formerly known as INCB018424 or INC424, is an anticancer drug and a Janus kinase (JAK) inhibitor. It is a potent and selective inhibitor of JAK1 and JAK2, which are tyrosine kinases involved in cytokine signalling and hematopoiesis.

Myeloproliferative neoplasms, such as myelofibrosis and polycythemia vera, are often characterized by aberrant activation of the JAK-STAT pathway, leading to abnormal blood cell counts and thrombotic complications. By inhibiting JAK1 and JAK2, ruxolitinib works to block the dysregulated cell signalling pathways and prevent abnormal blood cell proliferation. Due to a large number of patients with myeloproliferative neoplasms who have JAK2 mutations, ruxolitinib was the first ATP-competitive inhibitor of JAK1 and JAK2 ever developed.

At the recent SEC meeting for Oncology held on 19th December 2024, the expert panel reviewed the Protocol Amendment Version 06 dated 29 Aug 2024 protocol no. CINC424A2X01B.

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

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