This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

17 Nov 2016

NICE ‘yes’ for chronic myeloid leukaemia pill

For patients this could mean more are able to achieve a normal life expectancy, without compromising on their quality of life.

Bristol-Myers Squibb (BMS) has announced that the National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Determination (FAD) recommending the use of Sprycel (dasatinib) for the treatment of eligible adults with the blood cancer, chronic myeloid leukaemia (CML). This guidance applies to both those who are newly diagnosed and those resistant or intolerant to previous treatment. The positive NICE decision will allow access to an effective treatment option shown to provide rapid and durable response against this cancer. For patients this could mean more are able to achieve a normal life expectancy, without compromising on their quality of life.

“Today’s decision from NICE is an important step forward in the treatment of CML,” said Doctor Jenny Byrne, Haematologist at Nottingham City Hospital. “The chronic nature of this disease means that treatment needs to be taken continuously and long-term; dasatinib is a treatment that could potentially enable many patients to achieve the goal of normal life-expectancy and to live as normal a life as possible.”

“The decision by NICE to recommend dasatinib is extremely good news for patients diagnosed with CML, a life-threatening blood cancer,” said Sandy Craine, Founder of The CML Support Group. “For people fighting this disease, timely access to potentially lifesaving targeted therapies such as dasatinib will very likely enable them to gain control over their disease and live out their normal lifespan. Access to targeted therapies such as dasatinib not only has the potential to extend their life expectancy but also represents a cost effective use of NHS resource. This is a progressive and forward thinking decision by NICE and will be welcomed by patients and clinicians alike throughout England.”

Dasatinib is licensed for first- and second-line CML and has long term clinical trial data in both these settings. In a Phase III study of newly diagnosed patients, a significantly higher proportion in the dasatinib vs. imatinib (a standard of care) group achieved the primary outcome of a confirmed complete cytogenetic response (cCCyR) by 12 months: 77% versus 66% patients respectively. Data on dasatinib in patients who had developed resistance or intolerance to previous treatment are based around Phase III and Phase II studies. In the Phase III studies, in patients with chronic, accelerated or blast phase CML, dasatinib produced haematological and cytogenetic responses.

“We are extremely pleased that NICE has recognised the significant benefits that dasatinib can offer people fighting chronic myeloid leukaemia,” said Benjamin Hickey, General Manager, BMS UK & Ireland. “Patients will now have access to an important treatment option that, in many patients, can improve their quality of life, while effectively managing the disease. We remain focused on our goal of changing the way people live with cancer and this is another vital milestone in that journey.”

Related News