- Scemblix provides much-needed and long-awaited new option for patients with chronic myeloid leukemia (CML) who suffer with intolerance or inadequate response after at least two previous tyrosine kinase inhibitor (TKI) treatments1
- In the pivotal Phase III ASCEMBL trial, Scemblix demonstrated significant and clinically meaningful superiority in major molecular response (MMR) rate vs. Bosulif®* (bosutinib) (25% vs. 13%) at 24 weeks, and more -than -three times lower discontinuation rates due to side effects (7% vs. 25%)2,3
- Additional Phase I data in patients with CML with the T315I mutation supported the FDA approval for a second indication in this patient population4
- With a new mechanism of action known in scientific literature as a STAMP inhibitor and clinical trials across treatment lines – including in the first-line setting –, Scemblix reinforces Novartis’ two-decade commitment to bring transformative therapies to people living with CML
Novartis blazoned moment that the US Food and Drug Administration (FDA) approved Scemblix ® (asciminib) for the treatment of habitual myeloid leukemia (CML) in two distinct suggestions. The FDA granted Scemblix accelerated blessing for adult cases with Philadelphia chromosome-positive CML in habitual phase (Ph CML-CP) preliminarily treated with two or further tyrosine kinase impediments (TKIs), grounded on major molecular response (MMR) rate at 24 weeks; and full blessing for adult cases with Ph CML-CP with the T315I mutation1. In agreement with the Accelerated Blessing Program, continued blessing for the first suggestion may be contingent upon verification and description of clinical benefit from confirmational evidence1. Scemblix is the first FDA-approved CML treatment that works by binding to the ABL myristoyl fund, and represents an important development for cases who witness resistance and/ or dogmatism to presently available TKI therapies1-3. Also known as a STAMP asset in scientific literature, Scemblix is being studied across multiple treatment lines for CML-CP, including the ASC4FIRST Phase III study assessing Scemblix as a first- line treatment2-18.
“ The preface of TKIs twenty times ago revolutionized treatment for CML; still, there remain numerous cases who don’t respond adequately to at least two available treatments and frequently witness grueling side goods that add a burden to their diurnal lives,” said Lee Greenberger, Chief Scientific Officer at The Leukemia & Lymphoma Society. “ The blessing of Scemblix may offer stopgap to cases by addressing gaps in CML care.”
The FDA blessing of Scemblix is grounded on results from the Phase III ASCEMBL trial and a Phase I (NCT02081378) study that included cases with Ph CML-CP with the T315I mutation.
In cases with Ph CML-CP who had endured resistance or dogmatism to at least two TKIs, the ASCEMBL trial showed that1-3
.Scemblix nearly doubled the MMR ratevs. Bosulif ® (bosutinib) * at 24 weeks (25vs. 13 (P = 0.029))
The proportion of cases who discontinued treatment due to adverse responses was further than three times lower in the Scemblix arm (n = 156)vs. cases in the Bosulif arm (n = 76) (7vs. 25)
The most common ( prevalence ≥ 20) adverse responses and laboratory abnormalities in the Scemblix arm were, independently upper respiratory tract infections and musculoskeletal pain; drop in platelet and neutrophil counts, drop in hemoglobin; increase in triglycerides, creatine kinase and alanine aminotransferase (ALT)
. “ After further than two decades of reimagining CML care, we continue to bravely push the boundaries of invention to transfigure the standard-of- care and help indeed more cases living with this complaint,” said Susanne Schaffert, PhD, President, Novartis Oncology. “ We’d like to thank all those who have been involved in helping to advance this new and important advance.”
Scemblix is presently available for croakers to define to applicable cases in the US.
Fresh efficacity and safety details for Scemblix, including data on cases with the T315I mutation, and full Prescribing Information can be plant at https//www.novartis.us/sites/www.novartis.us/files/scemblix.pdf.
About Scemblix ® (asciminib)
Scemblix (asciminib) is indicated for the treatment of adult cases with Ph CML-CPpre-treated with two or further TKIs, as well as adult cases with Ph CML-CP with the T315I mutation1. The first suggestion is approved under the US FDA Accelerated Blessing Program grounded on MMR rate at 24 weeks; continued blessing for the first suggestion may be contingent upon verification and description of clinical benefit from confirmational substantiation.
Scemblix is the first FDA-approved CML treatment that binds to the ABL myristoyl pocket1. This new medium of action, also known in scientific literature as a STAMP asset, may help address resistance in cases with CML preliminarily treated with two or further TKIs and overcome mutations at the imperfect BCR-ABL1 gene, which is associated with theover-production of leukemic cells2-11. Scemblix has also been shown to limit out- target exertion inpre-clinical studies31.
Novartis has initiated nonsupervisory forms for Scemblix in multiple countries and regions across the globe.
Scemblix represents an important development for cases who witness resistance and/ or dogmatism to presently available TKI curatives, and it’s being studied across multiple treatment lines for CML-CP 2-18. Specifically, the ASC4FIRST Phase III study (NCT04971226) evaluates Scemblix as a first- line treatment and is in the reclamation phase13.
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