NICE approval of MYLOTARG ™▼ for acute myeloid leukaemia

Strong opioid painkiller users have twice the risk of hip fracture compared to non-opioid users.
Moderately strong opioids associated with a two-fold risk of hip fracture, and strong opioids with almost a three-fold risk.

Pfizer comment on the NICE approval of MYLOTARG ™▼ (gemtuzumab ozogamicin) for treatment of previously untreated, de novo, CD33-positive acute myeloid leukaemia (AML) in combination with chemotherapy. 

MYLOTARG will now be available through the National Health Service (NHS) for eligible patients in England and Wales.

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 10 months. The goal of AML treatment is to help patients achieve a prolonged complete remission, however, few new treatment options have become available for AML patients in the last few decades, with chemotherapy remaining the standard-of-care since the 1970s.

“Gemtuzumab ozogamicin is a targeted therapy that is given with standard chemotherapy and prolongs the time spent in remission compared to standard treatments”

The Final Appraisal Determination (FAD), NICE approval of MYLOTARG, recommends use in combination with daunorubicin and cytarabine as an option for untreated CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia, in people 15 years and over, only if they start induction therapy when either the cytogenetic test confirms that the disease has favourable, intermediate or unknown cytogenetics or when their cytogenetic test results are not yet available, and they start consolidation therapy when their cytogenetic test confirms that the disease has favourable, intermediate or unknown cytogenetics (because the test was unsuccessful).

Craig Eagle, Head of Oncology, Pfizer UK said: “We welcome the NICE approval of MYLOTARG for eligible patients living with AML. Pfizer has worked tirelessly with the AML community to ensure patients in the UK have access to appropriate treatment options and this important, potentially life-changing medicine offers renewed hope for some people living with AML in England and Wales.”

Haematologist Professor Nigel Russell from the Centre for Clinical Haematology, Nottingham University Hospital Trust said “Over the past few decades, there has been little innovation in how we treat AML. Despite slow improvements in outcomes, the prognosis for patients with this type of blood cancer remains poor. Gemtuzumab ozogamicin is a targeted therapy that is given with standard chemotherapy and prolongs the time spent in remission compared to standard treatments. It provides a welcome addition to the treatment options for eligible patients with AML and is an important step towards ensuring that some very sick blood cancer patients can access appropriate treatments to achieve a prolonged, complete remission.”

Novartis’ Kymriah was approved for acute lymphoblastic leukaemia earlier this year while NICE rejected Janssen’s Imbruvica and NICE have reconsidered their view on Pfizer’s BESPONSA