Novartis gets CDSCO panel nod to study anticancer drug Asciminib

This came after the firm presented their justification for the conduct of clinical trial Phase IIIb where the primary objective of the study is safety and also submitted regulatory approval from Germany and France for protocol number: CABL001J12302 Version 00 (Original protocol dated 24-May-22) before the committee.

Asciminib is a tyrosine kinase inhibitor (TKI) used in the treatment of chronic-phase Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). More specifically, it is an inhibitor of the ABL1 kinase activity of the BCR-ABL1 fusion protein which serves as a driver of CML proliferation in most patients with the disease.

Asciminib is an inhibitor of ABL/BCR-ABL1 tyrosine kinase for the treatment of patients with Philadelphia chromosome-positive CML, including those with the T315I mutation.

Asciminib is indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) in the chronic phase who have been previously treated with ≥2 tyrosine kinase inhibitors. It is also indicated in the treatment of Ph+ CML in adult patients with the T315I mutation. Asciminib is an allosteric inhibitor of the BCR-ABL1 tyrosine kinase. It binds to the myristoyl pocket of the ABL1 portion of the fusion protein and locks it into an inactive conformation, preventing its oncogenic activity.

At the recent SEC meeting for the Oncology and Hematology held 11th May 2023, the expert panel reviewed the justification for the conduct of clinical trial Phase IIIb provided by the drug major Novartis.

The expert panel noted that the primary objective of the study is safety. Furthermore, the committee noted that the firm submitted regulatory approval from Germany & France for protocol number: CABL001J12302 Version 00 (Original protocol dated 24-May-22) before the committee.

After detailed deliberation, the committee recommended the grant of permission to conduct the phase IIIb clinical trial of ABL001 (Asciminib) as presented by the firm.

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