Novartis Healthcare Gets CDSCO Panel Nod To study Anti-cancer Drug Asciminib

New Delhi: Novartis Healthcare has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the trial of the anti-cancer drug Asciminib.

This came after the firm presented phase IIIb clinical study protocol no. CABL001A2001B Version number: 03 dated 17 May 2024. This is an open label, multi-center asciminib roll-over study to assess long-term safety in patients who have completed a Novartis sponsored asciminib study and are judged by the investigator to benefit from continued treatment.

Asciminib, also known as ABL001, is a medication used to treat Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase. It works by inhibiting the BCR-ABL1 kinase, a protein that is often mutated in CML and drives the disease. Asciminib is distinct from other CML treatments because it targets a specific part of the BCR-ABL1 kinase called the myristoyl pocket, rather than the ATP-binding site.

At the recent SEC meeting for Oncology held on 11th March 2025, the expert panel reviewed the phase IIIb clinical study protocol no. CABL001A2001B Version number: 03 dated 17 May 2024.

After detailed deliberation, the committee recommended the grant of permission to conduct the trial as presented by the firm.

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