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New treatment for rare forms of leukaemia available across Scotland

ARIAD today welcomed the Scottish Medicine Consortium’s (SMC) acceptance to use Iclusig® (ponatinib) as a clinical and cost effective treatment for all phases of chronic myeloid leukaemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL), in accordance with Iclusig’s licenced indication.

CML is a cancer of the white blood cells that is diagnosed in approximately 7,000 patients annually in Europe. (1) Each year there are up to 106 new cases of CML in Scotland. (2)

ARIAD today welcomed the Scottish Medicine Consortium’s (SMC) acceptance to use Iclusig® (ponatinib) as a clinical and cost effective treatment for all phases of chronic myeloid leukaemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL), in accordance with Iclusig’s licenced indication.

CML is a cancer of the white blood cells that is diagnosed in approximately 7,000 patients annually in Europe. (1) Each year there are up to 106 new cases of CML in Scotland. (2)

Professor Mhairi Copland from the University of Glasgow said “Today’s decision by the SMC to approve ponatinib for leukaemia patients in Scotland is good news.  A small number of patients fail on established treatments already available in Scotland and having access to new drug therapies can make a big difference in managing these patients with leukaemia.  The new SMC process is allowing good decisions to be made that will benefit patients and their families, making new and effective treatments available to those patients that require them.

Adding to this comment, ARIAD UK General Manager Mark Tanner said “We are delighted that patients in Scotland now have full access to Iclusig following its approval in Wales earlier this year. This decision is a very positive signal of the value this treatment can bring to NHS patients with rare forms of leukaemia, for whom very few options exist. We hope that Iclusig will be reimbursed in England for the full licenced indications in the near future so that there will be equity of access to Iclusig across the UK.

Iclusig has been accepted for use in Scotland according to the licensed indications, that is, for the treatment of 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.
  • Philadelphia chromosome Ph+ ALL who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation. (3)

The SMC decision follows the approval of Iclusig by the All Wales Medicines Strategy Group (AWMSG) under the same indications on 13 January 2015.

The Chronic Myeloid Leukaemia Support Group (CMLS Group) welcomes the decision of the SMC to recommend Iclusig for use in all its licenced indications,” commented David Ryner, Chair of the CMLS Group. “This is in stark contrast to the situation in England, where a very limited number of CML patients only have access to Iclusig if their clinician has made a successful application to the Cancer Drugs Fund (CDF), due to expire in March 2016. We would urge the government’s review bodies to take note of the evaluation environment in England that systematically disadvantages small cancer patient sub populations.

Tony Gavin, Director of Campaigning & Advocacy at Leukaemia CARE, added “The SMC’s decision is excellent news for CML patients who have failed to respond to the currently best available treatment options for their disease. The approval now brings Scotland in line with Wales. Unfortunately for similar patients in England this is not yet the case, causing an inequitable situation which needs to be remedied as soon as possible to avoid post code prescribing.”

About Iclusig® (ponatinib)
Iclusig is a kinase inhibitor. The primary target for Iclusig is BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic myeloid leukaemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukaemia (Ph+ ALL). Iclusig was designed using ARIAD’s computational and structure-based drug design platform specifically to inhibit the activity of BCR-ABL. Iclusig targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs.
About CML and Ph+ ALL
CML is a cancer of the white blood cells that is diagnosed in approximately 7000 patients each year in Europe. (5) CML is characterised by an excessive and unregulated production of white blood cells by the bone marrow due to a genetic abnormality that produces the BCR-ABL protein. After a chronic phase of production of too many white blood cells, CML typically evolves to the more aggressive phases referred to as accelerated phase and blast crisis. Ph+ ALL is a subtype of acute lymphoblastic leukaemia that carries the Ph+ chromosome that produces BCR-ABL. It has a more aggressive course than CML and is often treated with a combination of chemotherapy and tyrosine kinase inhibitors. The BCR-ABL protein is expressed in both of these diseases.

About ARIAD
ARIAD Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts and Lausanne, Switzerland, is an integrated global oncology company focused on transforming the lives of cancer patients with breakthrough medicines. ARIAD is working on new medicines to advance the treatment of various forms of chronic and acute leukaemia, lung cancer and other difficult-to-treat cancers. ARIAD utilises computational and structural approaches to design small-molecule drugs that overcome resistance to existing cancer medicines. For additional information, visit http://www.ariad.com or follow ARIAD on Twitter (@ARIADPharm).
Iclusig® is a registered trademark of ARIAD Pharmaceuticals, Inc.

References:

  1. Rohrbacher M, Hasford J. Epidemiology of chronic myeloid leukaemia (CML). Best Pract Res Clin Haematol 2009 Sep;22(3):295–302. Based on current estimate of population of Europe (738,199,000 in 2010).
  2. “2011 Census: First Results on Population Estimates for Scotland – Release 1A”. National Records of Scotland. 17 December 2012. Retrieved 20 December 2012.
  3. Scottish Medicine Consortium (SMC) Advice, available here:  http://www.scottishmedicines.org.uk/SMC_Advice/Advice/1032_15_ponatinib_Iclusig/ponatinib_Iclusig.


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