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Novartis Receives Breakthrough Therapy Designations for Chronic Myeloid Leukemia Drug

· 02/08/2021 01:33

06:28 AM EST, 02/08/2021 (MT Newswires) -- Novartis (NVS) said premarket Monday that the Food and Drug Administration has granted Breakthrough Therapy designation to asciminib for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia previously treated with two or more tyrosine kinase inhibitors.

Asciminib was also granted the designation for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia harboring the T315I mutation, the company said.

Novartis also said it plans to submit its first regulatory filing in pre-treated patients in first half of this year under the FDA Real-Time Oncology Review program.

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