Novartis receives vital licence for Scemblix

Therapy represents the first STAMP inhibitor for patients with chronic myeloid leukaemia

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).

The treatment involves patients with Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) in chronic phase, previously treated with two or more tyrosine kinase inhibitors (TKIs), and without a known T315I mutation.

The authorisation of Scemblix is based on results from the phase 3 ASCEMBL trial among patients who had experienced resistance or intolerance to at least two TKIs.

During the trial Scemblix nearly doubled the major molecular response rate in contrast to bosutinib at 24 weeks. Meanwhile, the proportion of patients who discontinued treatment due to adverse reactions was more than three times lower in the Scemblix arm compared to bosutinib.

“While TKIs have revolutionised treatment for CML since their introduction, thousands of people living with CML in the UK need additional treatment options. Over time, people living with CML can develop intolerance or resistance to their current treatment, and until now the alternative has been a treatment with a similar mechanism of action,” reflected Professor Jane Apperley, chair of the department of haematology and the chief of service for clinical haematology at the Imperial College of London.

“With its innovative mechanism of action, asciminib is an important and welcome addition to the treatment options available for third-line therapy, that may support outcomes for eligible patients living with CML,” she added.

Scemblix has been available to specific eligible patients in the UK since January 2022 – under the MHRA Early Access to Medicines Scheme. It is currently under review by the National Institute for Health and Care Excellence (NICE) and Scottish Medicines Consortium (SMC), with guidance anticipated in the coming months.

There are around 830 new cases of CML every year in the UK and most patients require treatment throughout their lives. Around half of patients treated with a TKI require a change of treatment due to intolerance or developing resistance to treatment.

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