Thalomid, which is also known as thalidomide, has been halted by drug company Celgene earlier than expected after the drug was shown to limit the progression of the blood cancer multiple myeloma.

It was revealed during the phase 3 trial of 270 patients that thalomid offers great benefits to patients who are suffering from blood cancer. These results prompted the decision that the trial patients not on this drug should also be given an opportunity to add thalomid to their treatment regimen.

From News-Medical.Net:

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.

Celgene has also recently sought approval from the FDA for Revlimid for the treatment of last-stage multiple myeloma.

Tags: blood cancer, dexamethasone, multiple myeloma, thalidomide, thalomid

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