BETHESDA, MD 11 February 2013—FDA on February 8 announced the approval of pomalidomide, a thalidomide analogue, as a treatment for multiple myeloma that has progressed after previous therapies.
for pomalidomide states that the drug is indicated in patients who have undergone at least two cycles of therapy for multiple myeloma, including treatment with lenalidomide and bortezomib, but whose disease has progressed within 60 days after finishing the most recent treatment cycle.
Celgene will market pomalidomide oral capsules as Pomalyst. The company has not announced a launch date for the product.
FDA stated that pomalidomide was approved on the basis of the drug's ability to induce a hematologic response in patients with relapsed and refractory multiple myeloma. It is not yet known whether pomalidomide improves survival in patients with the disease.
Pomalidomide was approved with a medication guide and a risk evaluation and mitigation strategy (REMS) program that seek to prevent fetal exposure to the drug.
Prescribers and pharmacists must be specially certified to participate in the REMS program for pomalidomide, and only authorized patients may receive the drug. The REMS program includes contraceptive requirements for male and female patients and regular pregnancy testing for women of childbearing age who receive the drug.
FDA stated that the REMS program for pomalidomide is similar to the programs for lenalidomide and thalidomide.
The labeling for pomalidomide includes a boxed warning about the drug's teratogenicity as well as thrombotic events that were reported during clinical trials.
According to the labeling, all clinical trial participants were treated with aspirin, warfarin, heparin, or clopidogrel to treat or reduce the risk of venous thromboembolism, which occurred in 3% of participants nonetheless. The labeling recommends that clinicians consider prophylaxis with an anticoagulant during pomalidomide treatment.
The recommended dosage of pomalidomide is 4 mg/day taken on days 1–21 of a 28-day treatment cycle. The cycles should continue until the disease progresses.
The labeling includes recommendations for modifying the dosage in response to adverse hematologic events and other toxicities. Therapy should be discontinued if toxicity occurs at a dosage of 1 mg per day.
Pomalidomide will be supplied as 1-, 2-, 3-, and 4-mg capsules in bottles of 21 or 100 capsules each. The bottles should be stored at controlled room temperature.
The labeling recommends that health care providers who may have pomalidomide capsules in the workplace consider handling and discarding those capsules in accordance with accepted procedures for the proper handling and disposal of anticancer drugs.