Thalomid gives hope for blood cancer sufferers

Jan 9 2006

Drug company Celgene says it has halted a pivotal-stage trial of its Thalomid drug earlier than expected after the drug was shown to dramatically limit the progress of the blood cancer multiple myeloma.

The drug Thalomid, also known as thalidomide, which was first introduced in the 1950s became famous for causing birth defects, but is currently approved for treating a symptom of leprosy.

This latest Phase 3 trial of 270 patients found that that it took an average of 75.7 weeks for multiple myeloma to progress in previously untreated patients given a combination of thalidomide and the steroid dexamethasone, compared with 27.9 weeks for those treated with dexamethasone alone.

The encouraging results prompted the decision that the trial patients not on Thalomid should also be given the opportunity to add the drug to their treatment regimen.

Multiple myeloma is a cancer of the blood in which malignant plasma cells, or white blood cells, are overproduced in the bone marrow.

According to Celgene spokesman Brian Gill, Thalomid is currently the most widely prescribed drug for multiple myeloma.

It seems that while companies are not allowed to actively promote a drug for a condition for which it is not approved by regulators, doctors are allowed to prescribe it "off-label" for any disease.

Celgene is now chasing formal U.S. Food and Drug Administration approval for Thalomid to be used in multiple myeloma.

The FDA has however asked for updated safety information before allowing the drug to be marketed for treating newly diagnosed multiple myeloma.

Some of the side effects seen in the trial included insomnia, tremors and dizziness, and more than 10 percent of the Thalomid patients suffered deep vein thrombosis, compared with 1.7 percent of patients treated only with dexamethasone.

Pulmonary embolism occurred in 5.6 percent of Thalomid patients, compared with 1.7 percent of patients treated with dexamethasone alone.

Gill says the company is planning a wider commercial launch next year of both Thalomid and a successor drug, Revlimid, which was approved by the FDA in December for treating a group of blood disorders known as myelodysplastic syndromes.

The company has also recently sought FDA approval of Revlimid to treat late-stage multiple myeloma.