Chronic Myeloid Leukaemia (CML) patients in England who are resistant or intolerant to second generation tyrosine kinase inhibitor (TKI) therapies are on the brink of getting full-access to Incyte’s Iclusig on the NHS following a nod from NICE.

The Institute has now published a Final Appraisal Determination (FAD) recommending the drug’s use to treat adult patients with chronic phase, accelerated phase, or blast phase CML who are resistant to dasatinib or nilotinib, who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate, or who have the T315I mutation.

The guidelines bring patients in England in line with those in Wales and Scotland who have had full-access to Iclusig (ponatinib) - as per its licensed indications - since 2015.

“Together with the CML community, we have worked very hard over the last four years to encourage NICE to reconsider their original evaluation and are delighted that NICE has acknowledged the unmet need and the value that Iclusig brings,” said Mark Tanner, general manager of Incyte Bioscience UK, commenting on the decision.

CML is a rare blood cancer with around 700 new cases each year in the UK. According to Incyte, many patients with a new diagnosis of CML have a prolonged clinical benefit from targeted therapy with tyrosine kinase inhibitors (TKIs), but there is a high unmet need and poor prognosis for patients whose advanced disease is resistant and intolerant to other therapies.

Iclusig, which was cleared by the European Commission in 2013 as an orphan drug, has been available to patients in England through the Cancer Drugs Fund; NICE backing will enable the drug to enter the NHS' routine commissioning stream.

Incyte estimates that around 100 patients a year with CML and 33 patients with ALL would be eligible for treatment with the drug.

The company holds an exclusive license from ARIAD Pharmaceuticals, a wholly owned subsidiary of Takeda Pharmaceutical Co, to develop and commercialise the in the European Union and 28 other countries, including Switzerland, Norway, Turkey, Israel and Russia.