Novartis Healthcare Gets CDSCO Panel Nod To study Anti-cancer Drug Asciminib
New Delhi: Pharmaceutical major Novartis Healthcare has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct the trial of the anti-cancer drug ABL001 (Asciminib).
This came after Novartis Healthcare presented phase IIIb clinical study protocol no. CABL001A2001B Version number: 03 dated 17 May 2024.
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.
Asciminib, a novel allosteric inhibitor, inhibits the BCR-ABL1 tyrosine kinase activity by specifically binding to the ABL1 myristoyl pocket, inducing an inactive conformation and preventing the kinase from signaling, unlike traditional ATP-competitive inhibitors.
Asciminib is a medication used to treat Philadelphia chromosome-positive chronic myeloid leukemia (CML), specifically in patients who have failed two or more tyrosine kinase inhibitor (TKI) treatments or have the T315I mutation. It's an allosteric inhibitor that targets the myristoyl pocket of the ABL1 kinase, a mechanism distinct from other TKIs.
At the recent SEC meeting for Oncology held 11th March 2025, the expert panel reviewed the proposed phase IIIb clinical study protocol no. CABL001A2001B Version number: 03 dated 17 May 2024.
After detailed deliberation, the committee recommended granting permission to conduct the trial as presented by the firm.
