FDA Approval for Plerixafor
Brand name: Mozobil™
- Approved for non-Hodgkin lymphoma and multiple myeloma
Full prescribing information is available, including clinical trial information, safety, dosing, drug-drug interactions and contraindications.
On December 15, 2008, the U. S. Food and Drug Administration (FDA) approved plerixafor, solution for subcutaneous injection, (Mozobil™, Genzyme Corp.) for use in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin lymphoma (NHL) and multiple myeloma (MM).
The efficacy and safety of plerixafor in combination with G-CSF in NHL and MM were evaluated in two placebo-controlled studies (Studies 1 and 2). Patients were randomized to receive either plerixafor 0.24 mg/kg or placebo each evening prior to apheresis. All patients received G-CSF 10 micrograms/kg daily for four days prior to the first dose of plerixafor or placebo and prior to apheresis. Results from 298 patients with NHL from Study 1 and 302 patients with MM from Study 2 were analyzed.
In Study 1, 59 percent of patients with NHL who were mobilized with plerixafor and G-CSF collected ≥ 5 X 106 CD34+ cells/kg from the peripheral blood in four or fewer apheresis sessions compared with 20 percent of patients who were mobilized with placebo and G-CSF (p < 0.001). The median number of days to reach ≥ 5 x 106 CD34+ cells/kg was three days for the plerixafor group and not evaluable for the placebo group.
In Study 2, 72 percent of patients with MM who were mobilized with plerixafor and G-CSF collected ≥ 6 X 106 CD34+ cells/kg from the peripheral blood in two or fewer apheresis sessions compared with 34 percent of patients who were mobilized with placebo and G-CSF (p <0.001). The median number of days to reach ≥ 6 x 106 CD34+ cells/kg was one day for the plerixafor group and four days for the placebo group.
Safety data for plerixafor in combination with G-CSF were obtained from 983 patients enrolled in 16 clinical studies (593 patients enrolled in randomized Studies 1 and 2 plus 410 patients enrolled in 14 additional non-randomized studies). Patients were primarily treated with plerixafor at daily doses of 0.24 mg/kg SC. Median exposure to plerixafor was two days (range one to seven days).
The most common adverse reactions (≥ 10 percent) reported in patients who received plerixafor in conjunction with G-CSF that were more frequent than in patients who received placebo were diarrhea, nausea, fatigue, injection site reactions, headache, arthralgia, dizziness and vomiting. Prescribing physicians and patients should be aware of the potential for tumor cell mobilization in leukemia patients, increased circulating leukocytes and decreased platelet counts, splenic enlargement, and fetal harm when administered to pregnant women.
This summary was provided by Richard Pazdur, M.D., director of the FDA's Division of Oncology Drug Products.
The FDA is the division of the U.S. Department of Health and Human Services charged with ensuring the safety and effectiveness of new drugs and other products. (See "Learn How Drugs and Devices Get Approved.") The FDA's mission is to promote and protect the public health by helping safe and effective products to reach the market in a timely way, and monitoring products for continued safety after they are in use.