FDA approve Novartis’ Scemblix to treat leukaemia

pharmafile | November 2, 2021 | News story | Manufacturing and Production  

Novartis have announced that the FDA approved Scemblix® (asciminib) for the treatment of chronic myeloid leukaemia (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 or TKIs, based on major molecular response (MMR) rate at 24 weeks. The FDA also granted full approval for adult patients with Ph+CML-CP with the T315I mutation.

Dr Michael J Mauro, Hematologist and Myeloproliferative Neoplasms Program Leader at Memorial Sloan Kettering Cancer Centre (MDK) has said: “CML can be difficult to treat when currently available treatments fail patients, when treatment side effects cannot be tolerated, or sometimes both.” In an analysis of patients with CML treated with two prior TKIs, approximately 55% reported intolerance to previous treatment.

Dr Mauro added: “The addition of Scemblix into the CML treatment landscapes 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.”

“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, PhD, President, Novartis Oncology. “We would like to thank all those who have been involved in helping to advance this new important breakthrough.”

Scemblix is currently available for physicians to prescribe to appropriate patients in the US.

Novartis maintains a long-standing scientific commitment to patients living with CML.

Ana Ovey

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