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

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2025-05-16 12:15 GMT | Update On 2025-05-16 12:15 GMT

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.

Also Read: Bombay HC Notice to CDSCO on Denial of Phase I Trial for Indigenous Cancer Drug

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Dr. Divya Colin

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

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

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