Submit serious adverse events, deaths occurred during CT: CDSCO Panel Tells Novartis on Ruxolitinib
New Delhi: With respect to the safety and efficacy data of global study and post-marketing data related to the Ruxolitinib tablets 5mg,10mg, 15mg, and 20mg, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined the drug major, Novartis to submit details of serious adverse events, and deaths that occurred during the trials of the anticancer drug ruxolitinib along with causality assessment.
This came after the firm presented the safety and efficacy data of a global study and post-marketing data related to the Ruxolitinib tablets 5mg, 10mg, 15mg, and 20mg for the indication,
“Ruxolitinib is indicated for the treatment of patients aged 12 years and older with acute graft versus host disease or chronic graft versus host disease who have an inadequate response to corticosteroids or other systemic therapies”
Ruxolitinib is a kinase inhibitor used to treat various types of myelofibrosis, and polycythemia vera in patients who have not responded to or cannot tolerate hydroxyurea, and to treat graft-versus-host disease in cases that are refractory to steroid treatment.
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. It is indicated for the treatment of patients with intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis.
At the recent SEC meeting for Oncology and Hematology held on the 27th of April 2023, the expert panel reviewed the safety and efficacy data of global study and post-marketing data related to the Ruxolitinib tablets 5mg, 10mg, 15mg, and 20mg for the indication “Ruxolitinib is indicated for the treatment of patients aged 12 years and older with acute graft versus host disease or chronic graft versus host disease who have an inadequate response to corticosteroids or other systemic therapies”.
After detailed deliberation, the committee recommended,
"The firm should submit details of serious adverse events, and deaths that occurred during the trials along with causality assessment for further review by the committee."
