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Scemblix`s Scemblix (asciminib) Receives Approval in Europe
Novartis`s Scemblix (asciminib) Receives Approval in Europe
DORVAL, QC, Aug. 31, 2022 /CNW Telbec/ - Novartis Pharmaceuticals Canada Inc. is pleased to announce that Health Canada has approved Scemblix™ (asciminib tablets) for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) previously treated with two or more tyrosine kinase inhibitors (TKIs)1.
Novartis UK has announced that Scemblix – also known as asciminib – has been granted marketing authorisation in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA).
Consequently, adult patients with chronic myeloid leukaemia (CML), without the T215I mutation, who have previously been treated with two or more tyrosine kinase inhibitors (TKIs), can now gain access to asciminib.
Scemblix, as asciminib will be marketed, will be the first STAMP inhibitor approved for chronic myeloid leukemia, according to Novartis.
Basel, October 29, 2021 — Novartis announced today that the US Food and Drug Administration (FDA) approved Scemblix® (asciminib) for the treatment of chronic myeloid leukemia (CML) in two distinct indications. The FDA granted Scemblix accelerated approval for adult patients with Philadelphia chromosome-positive CML in chronic phase (Ph+ CML-CP) previously treated with two or more tyrosine kinase inhibitors (TKIs), based on major molecular response (MMR) rate at 24 weeks; and full approval for adult patients with Ph+ CML-CP with the T315I mutation1. In accordance with the Accelerated Approval Program, continued approval for the first indication may be contingent upon verification and description of clinical benefit from confirmatory evidence1. Scemblix is the first FDA-approved CML treatment that works by binding to the ABL myristoyl pocket, and represents an important development for patients who experience resistance and/or intolerance to currently available TKI therapies1-3. Also known as a STAMP inhibitor in scientific literature, Scemblix is being studied across multiple treatment lines for CML-CP, including the ASC4FIRST Phase III study evaluating Scemblix as a first-line treatment2-18