Ibrutinib approved for CLL- can WM be far behind?

Ibrutinib approved for CLL- can WM be far behind?


NICE has announced that Ibrutinib (Imbruvica® ) is to be approved for use in relapsed Chronic Lymphocytic Leukaemia. This removes it from the Cancer Drugs fund into routine commissioning. Ibrutinib in relapsed WM and Mantle Cell Leukaemia both await NICE decisions. In relapsed WM (and those not suitable for conventional chemo-immunotherapy), Janssen have applied to put the drug into the new Cancer Drugs Fund.
You can download the Janssen press release which mentions WM.

Final - Imbruvia NICE FAD medical press release 25.11.16 .pdf

NICE announced on 25th November that it has finally approved Ibrutinib for use under the complete licence for CLL, by NHS England, moving it from the Cancer Drugs Fund into routine commissioning .
Imminent decisions are awaited on its use in Mantle Cell Leukaemia and WM. 

Ibrutinib was licensed for use in the EU in WM in June 2105, but it has taken 17 months so far to achieve funding by NHS England. It is widely available for the three related diseases in Europe and North America.  WMUK has spent hundreds of hours with specialist WM doctors, supported by 22 specialists in the WMUK Doctor Forum, and we presented at the three NICE meetings so far, the second of which of which proposed provisional refusal. The result of the November meeting is awaited. If CDF approval is given, Janssen, NICE and WMUK aim to  work together to collect further data for at least two years on its effectiveness through the Rory Morrison Clinical Registry, set up and financed in 2015, largely your patient donations. 

NICE agreed with WMUK that it represented a step change in treatment and that WM has a significant unmet treatment need, but has to date declined to fund it.  

Ibrutinib is taken orally, and for a majority of relapsed patients turns WM into a chronic disease, but must be taken daily for life or until the disease progresses.

Download the Janssen release here Janssen CLL Release