Novartis obtains FDA green light for Scemblix
The Food and Drug Administration has given its blessing to Novartis for Scemblix (asciminib) for the treatment of chronic myeloid leukemia in two distinct indications.
The FDA granted Scemblix accelerated approval for adult patients with Philadelphia chromosome-positive CML in chronic phase, previously treated with two or more tyrosine kinase inhibitors, based on major molecular response rate at 24 weeks; and full approval for adult patients with Ph+ CML-CP with the T315I mutation.
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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.
"After more than two decades of reimagining CML care, we continue to boldly push the boundaries of innovation to transform the standard-of-care and help even more patients living with this disease," said Susanne Schaffert, president of Novartis Oncology. "We would like to thank all those who have been involved in helping to advance this new and important breakthrough."
"The introduction of TKIs twenty years ago revolutionized treatment for CML; however, there remain many patients who do not respond adequately to at least two available treatments and often experience challenging side effects that add a burden to their daily lives," said Lee Greenberger, chief scientific officer at The Leukemia & Lymphoma Society. "The approval of Scemblix may offer hope to patients by addressing gaps in CML care."
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"CML can be difficult to treat when currently available treatments fail patients, when treatment side effects cannot be tolerated, or sometimes both," said Dr. Michael Mauro, hematologist and Myeloproliferative Neoplasms program leader at Memorial Sloan Kettering Cancer Center. "The addition of Scemblix into the CML treatment landscape gives us a novel approach to combat this blood cancer, helping address clinical challenges in patients struggling after switching to a second treatment, as well as in patients who develop the T315I mutation and face significantly worse outcomes."