AWMSG Recommends SPRYCEL(R) For Use In NHS Wales
CML, although relatively rare, is a devastating condition which accounts for around 15% of all leukaemias.2Around 2,600 people in the UK are currently affected by CML,3which progresses through three stages: chronic, accelerated and blast. Although use in blast phase patients was not recommended by the AWMSG, most CML patients are diagnosed in the chronic phase,4 and so this recommendation will encompass the majority of eligible patients.
Commenting on the news, Dr Saad Al-Ismail, Lead Consultant Haematologist, Singleton Hospital, Swansea, said, "This is excellent news for the people in Wales living with CML, and for those new patients diagnosed every year. The AWMSG's decision means that dasatinib, an effective treatment for CML, is now readily available for those chronic and accelerated phase patients who become resistant or intolerant to imatinib."
The Scottish Medicines Consortium (SMC)5, and London Cancer New Drugs Group (LCNDG)6 issued their positive advice on SPRYCEL in April5 and May6 2007, respectively. The LCNDG supported the use of SPRYCEL in imatinib mesylate resistant or intolerant CML patients of all phases6, while the SMC only recommended SPRYCEL for those patients in the chronic phase.5 This new Welsh guidance goes further than the SMC, making the drug available to those imatinib intolerant or resistant patients in the chronic or accelerated phases of CML.1
Tony Gavin of the patient group Leukaemia CARE welcomed the AWMSG decision but noted the disparities in guidance and access to treatment within the UK. He said: "Leukaemia CARE believes in equal and fair access to treatment for all suitable patients throughout the UK. This AWMSG decision is great news for Welsh patients and follows the recent positive SMC decision. However, we now have a situation where unrestricted access to dasatinib is possible for suitable patients in Wales and Scotland, albeit perhaps in different disease phases, while similar patients in other parts of the UK may be still be denied this treatment. We must ensure that patients with CML don't have to campaign to receive treatments that are readily available elsewhere."
SPRYCEL was first approved by the European Commission in November 2006,7 as an oral tyrosine kinase inhibitor that blocks leukaemia cell growth, enabling adults with certain types of leukaemia to benefit from disease control over a sustained period of time.8SPRYCEL has a multi-targeted mode of action, as demonstrated in vitro, which may, amongst other molecular factors, explain its clinical effectiveness in the significant numbers of patients who fail on existing treatments including imatinib.8,9
Frank Pasqualone, Managing Director, Bristol-Myers Squibb Pharmaceuticals Limited welcomed the announcement. 'We are delighted with the decision. It now means even more chronic and accelerated phase CML patients, who are resistant or intolerant to imatinib, will have ready access to another treatment in their fight against this rare but life-threatening disease. Recommendations such as this make medicines more accessible to the patients who need them. SPRYCEL builds on our company's long legacy of providing innovative oncology medicines to patients. Furthermore, it is the latest example of executing our strategy to bring medicines to areas of significant unmet need and continues our mission to extend and enhance human life."
About SPRYCEL
SPRYCEL is indicated for the treatment of adults with chronic, accelerated or blast phase chronic myeloid leukaemia (CML) with resistance or intolerance to prior therapy including imatinib mesylate.10 It is also indicated for the treatment of adults with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy.10
The efficacy and safety profile of SPRYCEL was reviewed based on the analysis of five Phase II multi-centre studies in patients with resistance or intolerance to imatinib in all phases of CML or Ph+ ALL.10 SPRYCEL in vitro is 325 times more active at blocking the Bcr-Abl protein than imatinib11 and this may help maintain clinical activity against the high in vitro IC50s seen with kinase domain mutations that are known to be associated with a poor response. Unlike other therapies, SPRYCEL is also able to block the Bcr-Abl protein in both forms - active or inactive.10
About BMS
Bristol-Myers Squibb is a global pharmaceutical and related healthcare products company whose mission is to extend and enhance human life.
About Leukaemia CARE
Leukaemia CARE is a national charity that exists to provide vital care and support to all those whose lives are affected by leukaemia, lymphoma and the allied blood disorders. Leukaemia CARE's work extends to the welfare of families and carers, as well as that of patients themselves. The CARE-line, a free 24 hour dedicated telephone service for anyone needing support and advice is available on 0800 1696680.
All Wales Medicines Strategy Group Advice
CML:
Dasatinib (Sprycel®) is recommended for restricted use within NHS Wales for the treatment of adults with chronic phase chronic myeloid leukaemia (CML) and accelerated phase CML where there is resistance or intolerance to prior therapy including imatinib mesilate. The use of dasatinib for blast phase is not recommended.1
Resistance to imatinib is defined in accordance with the European LeukaemiaNet criteria and on completion of mutation analysis. Intolerance is defined as a patient experiencing prior grade 3/4 toxicity, in accordance with the National Cancer Institute Common Toxicity Criteria, to imatinib despite receiving the lowest clinically effective dose.1
Dasatinib (Sprycel®) should only be initiated by specialists experienced in the treatment of chronic myeloid leukaemia.1
Dasatinib (Sprycel®) is not presently recommended for shared care.1
Ph+ ALL and LB-CML:
Dasatinib (Sprycel®) is not recommended for use within NHS Wales for the treatment of adults with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL) and lymphoid blast chronic myeloid leukaemia (LB-CML) with resistance or intolerance to prior therapy.1
References
1. AWMSG guidance on dasatinib, December 2007. http://www.wales.nhs.uk/sites3/page.cfm?orgid=371&pid=24773
2. National Comprehensive Cancer Network (NCCN).Chronic Myelogenous Leukemia - clinical practice guidelines in oncology - v1 2007.
3. NICE Guidance on the use of imatinib for chronic myeloid leukaemia - Technology Appraisal 70. October 2003.
4. Faderl S, Talpaz M, Estrov Z, O'Brien S, Kurzrock R, Kantarjian H. N Engl J Med. 1999; 341: 164 - 176.
5. SMC guidance on dasatinib, 20mg,50mg, 70mg tablets (Sprycel), http://www.scottishmedicines.org.uk, May 2007.
6. The London Cancer New Drugs Group - Recommendations May 2007. http://www.nelm.nhs.uk/search/product.aspx?id=98
7. European Medicines Agency. European Public Assessment Report (EPAR), SPRYCEL Available here.
8. Talpaz M, Shah NP, Kantarijian H, et al. N Engl J Med. 2006;354:2531-2541.
9. Tokarski JS, Newitt JA, Chang CY, et al. Cancer Res. 2006;66(11):5790-7.
10. SPRYCEL Summary of Product Characteristics
11. O'Hare T, Walters DK, Stoffregen EP, et al. Cancer Res. 2005;65:4500-4505.
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View drug information on Sprycel.
AWMSG recomandã SPRYCEL (R) pentru a fi utilizate în NHS Wales - AWMSG Recommends SPRYCEL(R) For Use In NHS Wales - articole medicale engleza - startsanatate