England and Wales’ cost-effectiveness watchdog has backed the use of Incyte’s Iclusig (ponatinib) as a routine therapy for both chronic myeloid leukaemia (CML) and acute lymphoblastic leukaemia (ALL) NHS patients.  

The National Insitute for Health and Care Excellence (NICE) gave positive draft guidance for the drug based on it offering effective treatment and benefits over other therapies, such as Pfizer’s Bosulif (bosutinib).

Iclusig is now recommended for use in adult patients with chronic-phase CML who have a genetic mutation called T315I, and in those with accelerated or blast phase CML which is resistant to either BMS’ Sprycel (dasatinib) or Novartis’ Tasigna (nilotinib), Novartis’ Glivec (imatinib) is inappropriate, or when a T315I mutation is present.

In ALL, the drug can now be considered an option in Philadelphia chromosome-positive disease in the case of treatment resistance to Sprycel, the patient cannot have Sprycel or Glivec, or the T315I gene is present.

Incyte estimates that around 100 CML patients per year and 33 ALL patients per year will be eligible for treatment with Iclusig.

NICE has been reviewing 31 so-called ‘legacy’ drugs listed on the Cancer Drugs Fund from last year in an effort to make room for new breakthrough cancer therapies. By November, NICE had approved 9 out of 11 of the drugs it had reviewed, mainly thanks to drug price cuts or new clinical effectiveness data.

If given final approval by NICE, Iclusig will enter mainstream coverage across the NHS.