FDA approves fixed dose combination chemotherapy for subtypes of AML that have poor survival outcomes

The U.S. Food and Drug Administration (FDA) yesterday approved Vyxeos - a fixed dose combination chemotherapy for the treatment of adults with two types of acute myeloid leukemia (AML). The types of AML that would be treated with Vyxeos include newly diagnosed therapy-related AML (t-AML) and AML with myelodysplasia-related changes (AML-MRC). Vyxeos is a fixed-combination of the chemotherapy drugs daunorubicin and cytarabine.

According to Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, Vyxeos is the first approved treatment that may be used specifically for patients with high-risk AML. It combined two chemotherapy agents he explained, which when given separately could benefit patients less than if they were to be given in combination.

The daunorubicin-cytarabine combination is available in the form of vials in which the drugs are encapsulated in liposomes. Each vial contains 44 mg daunorubicin and 100 mg cytarabine.

For approval Vyxeos was tried in 309 patients, aged 60 to 75 years, who were newly diagnosed with t-AML or AML-MRC. They were divided into groups and while one group received Vyxeos, other group received separately administered treatments of daunorubicin and cytarabine. In the trial the standard separate regimen was 7-day cytarabine infusion plus daunorubicin on days 1, 2, and 3.

Survival of the patients on treatment was measured. Results revealed that patients on Vyxeos lived longer than those who received separate treatments of daunorubicin and cytarabine at 9.56 months vs. 5.95 months respectively.

Adverse effects of Vyxeos are similar to each of the drugs given separately. Vyxeos may lead to bleeding tendencies, lowered immunity leading to fever and infections, swelling of tissues, rash, inflamed mucous membranes, diarrhea, constipation, muscle pain, fatigue, nausea and vomiting, abdominal pain, shortness of breath, reduced appetite, cough, shortness of breath, abnormal heart rhythm, lung and blood infections, sleep problems etc.

Vyxeos cannot be given to patients who are allergic to any of its components. Pregnant and breastfeeding women are not to be prescribed Vyxeos warns the statement. Vyxeos cannot be interchanged with other daunorubicin- and/or cytarabine-containing products says the boxed label over the drug.

Vyxeos received an orphan drug status which means it was provided with incentives and tax reliefs to encourage its development. The approval for the drug is given to Jazz Pharmaceuticals.

AML - t-AML and AML-MRC

AML or acute myeloid leukemia is a rapidly progressing cancer of the bone marrow. There is increased number of white blood cells in the blood. According to the National Cancer Institute at the National Institutes of Health nearly 21,380 people will be diagnosed with AML in 2017 and a further 10,590 patients would succumb to it.

Therapy-related leukemia (t-AML) results as a complication of chemotherapy or radiation in nearly 8-10% of all the patients who have been treated for cancer within five years of their treatment of cancer. T-AML is common after treatment of several malignancies such as Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL), acute lymphoblastic leukemia (ALL), sarcoma, and ovarian and testes cancers. This cancer usually develops within 3-5 years after treatment and if the first ten years after treatment have passed uneventfully, the risk decreases. The risk is higher among those who have received a bone marrow transplant. Common risk factors that may give rise to t-AML include chemotherapy with an alkylating agent or radiation exposure or chemotherapy with a topoisomerase II inhibitor chemotherapeutic agent. Most of these cases show a poor response to conventional treatment and therapy and average survival after diagnosis is 6 months.

AML with myelodysplasia-related changes (AML-MRC) is another condition that is associated with myelodysplastic syndrome (MDS) or a myelodysplastic/myeloproliferative neoplasm and offers poor survival statistics. Typical features of this cancer include a blood picture showing features of MDS as well as AML. This results from certain genetic mutations and other blood disorders.

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