Celgene Corp. reveals new data from clinical trials of Thalomid® in solid tumour cancers
Clinical investigators from leading cancer research centers around the world have presented extensive clinical data on Thalomid® (thalidomide) in a broad range of hematological and solid tumor cancers at the Annual Meeting of the American Society of Clinical Oncology (ASCO).
Several presentations at ASCO have provided new information on the activity of Thalomid in such solid tumour cancers as renal cell carcinoma, prostate cancer and malignant melanoma.
Commenting on clinical trial data presented at ASCO on Thalomid in combination with chemotherapy, Sol J. Barer, Ph.D., President and Chief Operating Officer of Celgene Corporation, the manufacturer of Thalomid, announced that: "Celgene plans to expand clinical trials of Thalomid and seek regulatory approval to provide a potential treatment for cancer patients affected with solid tumor cancers."
About the safety of thalidomide
Thalidomide can cause severe birth defects or death to an unborn baby if taken during pregnancy. Therefore, thalidomide should never be used by women who are pregnant or who could become pregnant while taking the drug. Even a single dose, one capsule (50 mg, 100 mg and 200 mg), taken by a pregnant woman can cause severe birth defects and there is a risk of exposure to thalidomide from unprotected sexual contact with male patients taking thalidomide. Thalidomide can only be marketed under a special restricted distribution program. This program is called the "System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.®). Under this program, only registered prescribers and pharmacists may dispense the drug. In addition, patients must be advised of, agree to and comply with the requirements of S.T.E.P.S.
Thalidomide is known to cause nerve damage that may be permanent. Peripheral neuropathy is a common, potentially severe, side effect of treatment with thalidomide that may be irreversible. Decreased white blood cell counts, including neutropenia, have been reported in the clinical use of thalidomide. In placebo controlled clinical trials of HIV-seropositive patient populations, there have been reports of increased plasma HIV RNA levels associated with thalidomide therapy.
The most common adverse events observed in clinical use of thalidomide in erythema nodosum leprosum (ENL) and HIV-seropositive patient populations are rash, maculo-papular rash, drowsiness or somnolence, peripheral neuropathy, dizziness or orthostatic hypotension, neutropenia, and increased HIV-viral load.
About Thalomid (thalidomide)
Thalomid (thalidomide), manufactured by Celgene Corporation, received U.S. Food and Drug Administration (FDA) clearance on July 16, 1998 for the acute treatment of cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) and as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence. Thalomid is not indicated as monotherapy for ENL treatment in the presence of moderate to severe neuritis.
Keywords : Celgene Corporation Thalomid® Thalidomide Oncology Solid tumor cancers Clinical trials Development ASCO Safety Birth defects Neuropathy S.T.E.P.S. FDA approval
