CDSCO Panel Approves AstraZeneca's Proposal for Protocol Amendment of anti-cancer drug Asciminib
Written By : Dr. Divya Colin
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-01-02 00:00 GMT | Update On 2024-03-22 17:07 GMT
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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
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