Pharmacological Class:
Immunomodulator.
Active Ingredient(s):
Pomalidomide 1mg, 2mg, 3mg, 4mg; capsules.
Company
Celgene Corp
Indication(s):
Multiple myeloma, in patients who have received at least two prior therapies (including lenalidomide and bortezomib), and have shown disease progression on or within 60 days of completion of the last therapy. Clinical benefit, such as improvement in survival or symptoms, has not been verified.
Pharmacology:
Pomalidomide is a thalidomide analogue that inhibits proliferation and induces apoptosis of hematopoietic tumor cells. Pomalidomide also enhances T cell- and NK cell-mediated immunity and inhibits production of pro-inflammatory cytokines (eg, TNF-α, IL-6) by monocytes.
Clinical Trials:
The safety and efficacy of Pomalyst were eva luated in a Phase 2, multicenter, randomized, open-label study in patients with relapsed multiple myeloma who were refractory to their last myeloma therapy and had received lenalidomide and bortezomib. Patients were considered relapsed if they had achieved at least stable disease for at least one cycle of treatment to at least one prior regimen and then developed progressive disease. Patients were considered refractory if they experienced disease progression on or within 60 days of their last therapy. A total of 221 patients were randomized to receive Pomalyst alone or Pomalyst with low dose dexamethasone (Dex). In this trial, patients given Pomalyst 4mg, once daily for 21 of 28 days, until disease progression, were eva luated alone and in combination with low dose Dex (40mg/day for patients ≤75 years or 20mg/day for patients >75 years) given only on Days 1, 8, 15 and 22 of each 28-day cycle.
Results showed that overall response rate was achieved in the Pomalyst alone arm (7.4%; 95% CI 3.3, 14.1) vs. Pomalyst plus low-dose Dex arm (29.2%; 95% CI 21.0, 38.5) with a 7.4 month median duration of response. Also, partial response was demonstrated with 7.4% in the Pomalyst alone (n=8) arm vs. 28.3% in the Pomalyst with low-dose Dex (n=32) treatment arm.
Legal Classification:
Rx
Adults:
Swallow whole; may be taken with water. Take without food. 4mg once daily on Days 1–21 of repeated 28-day cycles until disease progression; may give with dexamethasone. Dose modification for hematologic and other Grade 3/4 toxicities: see full labeling.
Children:
<18 years: not established.
Contraindication(s):
Pregnancy (Category X): avoid during and for at least 4 weeks after completing therapy.
Warnings/Precautions:
Females of reproductive potential must commit either to abstain from heterosexual sex or to use two methods of reliable contraception, beginning 4 weeks prior to initiating, during therapy, dose interruptions and for 4 weeks after discontinuation. Obtain two negative pregnancy tests prior to initiating therapy: perform first test within 10–14 days, and second test within 24 hours prior to prescribing, and then weekly during first month, then monthly thereafter in women with regular menstrual cycles or every 2 weeks if irregular cycles. Males: must use latex or synthetic condom during therapy and up to 28 days after discontinuing, even after successful vasectomy; do not donate sperm. Patients must not donate blood during therapy and for 1 month after discontinuation. Venous thromboembolism; consider anticoagulation prophylaxis. Mon
