CDSCO Panel Approves AstraZeneca's Proposal for Protocol Amendment of anti-cancer drug Asciminib
New Delhi: The drug major Novartis has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) for the protocol amendment of the anti-cancer drug Asciminib.
This came after the drug major Novartis presented Protocol Amendment version 02 dated 15 May 2023, Protocol no. CABL001J12301.
The above study is a phase III, multicenter, open-label, randomized study of oral asciminib versus Investigator selected Tyrosine Kinase Inhibitor (TKI) in patients with newly diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase
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. It has also shown benefit in Ph+ CML with the T315I mutation, which produces a mutant BCR-ABL1 which is typically treatment-resistant as compared to wild-type BCR-ABL1.
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