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.
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 is in a class of medications called kinase inhibitors.
At the recent SEC meeting for Oncology and Hematology held on 29th and 30th November 2023, the expert panel reviewed the protocol amendment version 02 dated 15 May 2023, Protocol no. CABL001J12301.
After detailed deliberation, the committee recommended for approval of the protocol amendment as presented by the firm.
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