The FDA has granted accelerated approval to Celgene’s supplemental New Drug Application for thalidomide (Thalo-mid). The drug is used in combination with dexamethasone to treat newly diagnosed multiple myeloma, a cancer of the blood in which malignant plasma cells are overproduced in the bone marrow. Multiple myeloma is the second most common blood cancer in the U.S.
The agent’s effectiveness is based upon response rates; no controlled trials have shown a clinical benefit, such as improved survival.
Thalidomide is available through a special education and prescribing safety system. Common adverse effects include constipation, sensory neuropathy, confusion, hypocalcemia, edema, dyspnea, thrombosis or embolism, and rash or desquamation; these events occurred in 20% of patients with a frequency less than or equal to 10% in patients treated with thalidomide/dexamethasone compared with dexamethasone alone.
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The risk of venous thromboembolic events is increased risk when thalido-mide is used in combination with standard chemotherapeutic agents, including dexamethasone.
Thalidomide was approved in 1998 for the treatment of cutaneous manifestations of moderate-to-severe erythema nodosum leprosum and as maintenance therapy to prevent and suppress cutaneous manifestations of recurrence.
The capsules are available in strengths of 50, 100, and 200 mg.