Novartis UK has announced that the MHRA has given a positive scientific opinion for the investigational treatment, asciminib
Consequently, adult patients with chronic myeloid leukaemia (CML), without the T215I mutation, who have previously been treated with two or more tyrosine kinase inhibitors (TKIs), can now gain access to asciminib.
This decision makes asciminib the first STAMP inhibitor available to UK patients. Across the UK, there are approximately 830 new cases of CML per year and for a majority of patients this treatment is lifelong, while frequent switches of TKI treatment are common. Roughly half of these patients require a change of treatment due to intolerance or developing resistance to treatment and with each line of treatment, the rate of failure increases.
Dr Dragana Milojkovic, Professor of Practice (Chronic Myeloid Malignancies), Department of Immunology and Inflammation, Imperial College London, commented: “Despite several TKIs being available in the UK, thousands of people living with CML still need additional treatment options due to compromising side-effects or lack of efficacy of their current treatment.
“People living with CML can develop treatment resistance and intolerance over time, requiring a switch to an alternative treatment, usually another TKI. The introduction of asciminib, which has an innovative mechanism of action, is a very welcome and necessary addition to the treatment options available for third line therapy.”
“This decision allows eligible patients in the UK early access to our investigational treatment, and enables additional real-world evidence to be collected on its efficacy/safety profile while
the MHRA completes its full Marketing Autorisation Application review,” said Roland Kreissig, recently-appointed Oncology General Manager, Novartis UK and Ireland.
“Novartis has once again demonstrated its long-standing commitment to bold science with the aim of addressing the unmet needs of people living with chronic myeloid leukaemia,” he added.