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NICE issues final draft recommending Novartis’ Scemblix to treat chronic myeloid leukaemia

The recommendation makes Scemblix the first treatment in its class to be authorised in Britain


The National Institute for Health and Care Excellence (NICE) has issued a final draft recommendation for Novartis Pharmaceuticals UK’s Scemblix (asciminib) for patients with Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) in chronic phase (CP).

NICE’s decision will allow access to an innovative treatment channel which will help to address an unmet need for eligible people in England and Wales with CML who typically develop intolerance or resistance to current treatment with tyrosine kinase inhibitors (TKIs).

The decision makes Scemblix the first treatment in its class to be authorised in Britain.

The approval for recommendation of Scemblix – a specifically targeting the abl myristoyl pocket (STAMP) inhibitor – is for Ph+ CML patients in CP who have received previous treatment using two or more tyrosine kinase inhibitors, without a known T315I mutation.

“NICE’s positive recommendation for asciminib means that physicians can now consider an innovative treatment for people living with chronic myeloid leukaemia, a long-term debilitating and life-threatening condition,” said Heather Moses, Oncology country medical director, Novartis UK.

There are an estimated 830 new cases of CML a year in England and Wales, with most patients needing lifelong treatment and management.

For patients with CML, it is not uncommon to experience a change in treatment, with almost half of patients changing the TKI they are on after becoming intolerant or developing resistance. Failure rates, however, increase with each line of therapy.

Dr Dragana Milojkovic, Professor of Practice (Chronic Myeloid Malignancies), Department of Immunology and Inflammation, Imperial College London, said: “Over the past two decades, TKIs have been the mainstay of treatment for CML, however, over time patients often have to switch their treatment due to intolerance or resistance. A significant number of patients on second-line TKI treatment fail to achieve a satisfactory response after two years and are at risk of disease progression.

“Where the next treatment option has previously been another conventional TKI, today’s decision means that clinicians can now consider a novel TKI with an alternative mechanism of action, that may support outcomes for eligible CML patients.”

Article by
Fleur Jeffries

1st July 2022

From: Regulatory, Healthcare



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