On 22 February 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Mylotarg, intended for the treatment of acute myeloid leukaemia.
The approval allows doctors to prescribe the drug in combination with daunorubicin and cytarabine for patients aged 15 years and above with previously untreated, de novo, CD33-positive acute myeloid AML, except acute promyelocytic leukaemia (APL).
The decision gives patients the potential to access a new treatment option for their disease, as the drug is the first and only AML therapy approved in the EU that targets CD33, an antigen expressed on AML cells in up to 90 percent of patients.
“In clinical trials, the addition of gemtuzumab ozogamicin to standard chemotherapy resulted in more durable remission, thus providing an additional treatment option with the potential to prevent relapse for these patients,” noted Andreas Penk, regional president, Pfizer Oncology.
AML is a rapidly progressing, life-threatening blood and bone marrow cancer, which, if left untreated, can be fatal within weeks or months.
Every year, around 2,600 people in the UK are affected by the condition, with around 16,800 new cases diagnosed across Europe.
Mylotarg will be available as a 5-mg powder for concentrate for solution for infusion.
The active substance of Mylotarg, gemtuzumab ozogamicin, is a humanised immunoglobulin G subtype 4 (IgG4) antibody directed at CD33 which is conjugated to calicheamicin, a toxin which induces breaks in double-stranded DNA, subsequently inducing cell cycle arrest and apoptotic cell death. The benefit with Mylotarg is improvement in event-free survival.
The most common (> 30%) side effects of Mylotarg when used together with daunorubicin and cytarabine are haemorrhage and infection.
The full indication is: “Mylotarg is indicated for combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of patients age 15 years and above with previously untreated, de novo CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia (APL).”
It is proposed that Mylotarg should be prescribed by physicians experienced in the use of anticancer medicinal products.
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