Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions
FDA Approves Mylotarg for Certain Form of AML
Wyeth news release; 2017 Sep 1
The FDA has approved Mylotarg (gemtuzumab ozogamicin) for the treatment of adults newly diagnosed with a certain form of acute myeloid leukemia (AML).
Indications: Mylotarg is indicated for the treatment of patients with CD33 positive AML in first relapse who are ≥60 years of age and who are not considered candidates for other cytotoxic chemotherapy.
Dosage and administration:
- Administer 2 doses with 14 days between doses.
- 9 mg/m2, infused over a 2-hour period.
- Patients should receive the following prophylactic medications 1 hour before administration: diphenhydramine 50 mg po and acetaminophen 650-1000 mg po; thereafter, 2 additional doses of acetaminophen 650-1000 mg po, 1 every 4 hours as needed.
Efficacy and safety: Approval is based on results showing improved event-free survival when used in combination with daunorubicin and cytarabine, and improved overall survival when used as stand-alone treatment.
Side effects/risks: The most common adverse reactions are fever, nausea, chills, vomiting, headache, dyspnea, hypotension, hypertension, hyperglycemia, and hypoxia.
FDA approves Mylotarg for treatment of acute myeloid leukemia [news release]. Silver Spring, MD: FDA. September 1, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm574507.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed September 4, 2017.
Mylotarg [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals Inc. 2017. https://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4191B1_04_02-Wyeth-Insert.pdf. Accessed September 4, 2017.