Novartis Healthcare Gets CDSCO Panel Nod to Study Asciminib Filmcoated Tablets

New Delhi: Suggesting to add more government sites, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has granted approval to drug major Novartis Healthcare for conducting the Phase IV clinical study of the anti-cancer drug Asciminib film-coated tablets.

This came after Novartis Healthcare presented the proposal for the Phase IV clinical trial protocol of Asciminib film-coated tablets (20 mg and 40 mg).

Asciminib is in a class of medications called kinase inhibitors. Asciminib is used to treat a certain type of chronic myeloid leukemia (CML; a type of cancer of the white blood cells) as a first treatment and in people who can no longer benefit from other leukemia medications.

In most patients with chronic myeloid leukemia (CML), the progression of the disease is driven primarily by a translocation of the Philadelphia chromosome that creates an oncogenic fusion gene, BCR-ABL1, between the BCR and ABL1 genes. This fusion gene produces a resultant fusion protein, BCR-ABL1, which exhibits elevated tyrosine kinase and transforming activities that contribute to CML proliferation.

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 oncology held on July 9, 2024, the expert panel reviewed the proposal for the Phase IV clinical trial protocol of Asciminib film-coated tablets 20 mg and 40 mg.

After detailed deliberation, the committee recommended the conduct of a Phase IV clinical study as per the presented protocol.

In addition to the above, the committee opined that it may be desirable to add more government sites.

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