itor for hematologic toxicities (esp. neutropenia); obtain CBCs weekly for first 8 weeks and monthly thereafter; may need dose interruption and/or modification. Renal impairment (serum creatinine >3mg/dL) or hepatic impairment (serum bilirubin >2mg/dL and AST/ALT >3x ULN): avoid. Risk of hypersensitivity or second primary malignancies. Nursing mothers: not recommended.
Interaction(s)
May be potentiated by strong CYP1A2, CYP3A (eg, ketoconazole), or P-gp inhibitors; avoid. May be antagonized by strong CYP1A2, CYP3A (eg, rifampin), or P-gp inducers; avoid. Smoking may reduce efficacy.
Adverse Reaction(s)
Fatigue, asthenia, neutropenia, anemia, constipation, nausea, diarrhea, dyspnea, upper-respiratory tract infections, back pain, pyrexia; venous thromboembolism, dizziness, confusion, neuropathy, pneumonia, thrombocytopenia.
Notes:
Available only through Pomalyst REMS program.
How Supplied:
Caps—21, 100
LAST UPDATED:
5/24/2013
Pomalyst (pomalidomide) is an anti-angiogenic drug developed by Celgene Corporation for the treatment of multiple myeloma in patients who have received two prior therapies.
In February 2013, pomalyst received approval from the US Food and Drug Administration (FDA) for the treatment of patients with multiple myeloma.
Celgene also submitted the marketing authorisation application (MAA) for pomalyst to the European Medicines Agency (EMA) in June 2012. A decision on the MAA approval in Europe is expected to be announced by the second half of 2013.
Multiple myeloma, a type of cancer
Multiple myeloma is a type of cancer that occurs when malignant plasma cells grow out of control in the bone marrow. The disease also results in the forming of tumours in bones, which makes it difficult for bone marrow to produce healthy blood cells and platelets. The disease mainly affects older adults. According to the American Cancer Society's estimates, about 22,350 new cases of the disease will be diagnosed in the US, of which about 10,710 are expected to be fatal, in 2013.
Pomalyst's mechanism of action
Pomalyst contains an anti-angiogenic drug that works by restraining the growth of myeloma cells. The drug also contributes to anti-angiogenic and anti-myeloma activities. The drug is available in capsules form with 4mg doses for oral administration.
Clinical trials on pomalidomide
Celgene conducted Phase I clinical trials on Pomalyst between August 2011 and October 2011. It was a randomised, double blind, placebo controlled and parallel assignment. The study enrolled 33 patients in the US and eva luated the safety, efficacy, tolerability and pharmacokinetics of pomalyst. The primary outcome measure of the study was finding the number of participants with adverse events after 28 days. The secondary outcome measures of the study included maximum observed plasma concentration, terminal elimination half-life and apparent total plasma clearance.
Celgene initiated a Phase I/II clinical trial on pomalyst in November 2011. It is an open label, randomised and single group assignment. It enrolled more than 82 patients and will eva luate pomalyst in combination with high dose Dexamethasone and oral cyclophosphamide. The final results of the study are expected to be known by October 2013.
The primary outcome measures of the study will include finding the maximum tolerated dose in Phase I and finding the number of participan
