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New leukaemia therapy receives conditional approval from NICE

Thursday 31st May 2018
NICE has approved Mylotarg, a new treatment for acute myeloid leukaemia, for use among certain patient populations.
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A new treatment for acute myeloid leukaemia could be made available on the NHS following a conditional approval from the National Institute of Health and Care Excellence (NICE).

The UK regulator has issued draft guidance recommending the use of gemtuzumab ozogamicin, in combination with daunorubicin and cytarabine, for the treatment of patients aged 15 years and over with newly-diagnosed de novo CD33-positive acute myeloid leukaemia (AML).

The Pfizer-developed drug, which will be sold under the brand name Mylotarg, has not been approved for acute promyelocytic leukaemia, and can only be prescribed if the disease has favourable cytogenetics, or in cases where the individual's cytogenetic profile is unknown due to the cytogenetic analysis being unsuccessful.

AML is a rare and aggressive blood cancer that affects approximately 2,600 people in the UK each year. If left untreated, the average life expectancy is less than ten months, and very few new treatment options have become available for this disease in the last 40 years, meaning chemotherapy has remained the standard of care since the 1970s.

As such, there is a strong demand for new therapies such as Mylotarg. However, NICE has opted against recommending the drug for people whose disease has intermediate cytogenetic status, or for those whose cytogenetic test results have not yet been made available.

The regulator is requesting further information and analyses from manufacturer Pfizer before publishing its final guidance, meaning that the final recommendations could open access to the drug to a broader range of patients.

Craig Eagle, head of oncology at Pfizer UK, said: "We welcome today's preliminary decision to recommend the medicine for patients with favourable or unknown cytogenetics.

"However, this provisional recommendation currently excludes 65 per cent of the eligible patient population, and so we will continue working with NICE to help ensure that all patients who are eligible to benefit from this treatment are able to access it once a final recommendation is issued."

Written by James Puckle

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