Celegen Trial Ceased Over Deaths

celegen_revlimid_trial_stoppedDrug maker, Celgene Corp., ceased a Revlimid (lenalidomide) trial following a number of deaths. Revlimid is Celgene’s largest selling drug.

The study revealed that more people who were taking Revlimid died when compared to those who were taking a competitor’s drug, according to Bloomberg News. The study sought to broaden Revlimid use. Revlimid is approved for multiple myeloma in older patients diagnosed with B-cell chronic lymphocytic leukemia, a type of blood cancer. United States regulators put the trial on hold on January 12th, Celgene indicated in a statement.

Of the 210 patients involved in the study who were taking Revlimid, 34 died. In the other group, in which patients were being treated with the chemotherapy drug, chlorambucil, 18 of 211 patients died, according to Bloomberg News. Celgene told Bloomberg News  that it has not yet learned what caused the imbalance and will be continuing other trials studying lymphocytic leukemia.

Celgene was hoping to expand the use of Revlimid by adding new indications for the drug and this trial was meant to support Revlimid use in people age 65 and older diagnosed with issues that would prevent them from being treated with traditional chemotherapy, according to Bloomberg News.

“A majority of these patients that had died were much older, even 80 or older,” Greg Geissman, a Celgene spokesman told Bloomberg News. “These are patients who were not eligible for standard treatments. It’s a patient group in need, but elderly and frail, unfortunately.” Celgene determined that second primary malignancies, new cancers following treatment, were not a factor in the study’s outcome, noted Geissman.

Celgene amended the trial earlier this year, excluding people over the age of 80 from receiving the drug. The U.S. Food and Drug Administration then put the study on hold, Geissman said. Recent data since Celgene amended the trial revealed that three more deaths occurred in Revlimid patients bringing the number of deaths in the Revlimid group to 37 and to 28 in the chlorambucil group, Geissman told Bloomberg News.

As we’ve explained, Revlimid is approved to treat patients with multiple myeloma, a bone-marrow cancer in, combination with Decadron (dexamethasone). Revlimid is also approved to treat myelodysplastic syndromes.

Last year, the FDA  announced that new warnings would be added to the label of Revlimid regarding an increased risk of second cancers. According to the FDA’s announcement, studies conducted after Revlimid was approved found that newly diagnosed patients treated with the drug may be at risk of developing new malignancies, including acute myelogenous leukemia, a type of blood cancer; myelodysplastic syndromes (bone marrow conditions); and Hodgkin lymphoma.

At around the same time, Health Canada, the FDA’s Canadian counterpart, announced that information regarding the risk of second cancers would be added to the Revlimid label in that country. In Canada, Revlimid can only be prescribed to patients who are registered in and meet all of the conditions of the RevAid program, which is a controlled distribution program for the drug.

This entry was posted in Pharmaceuticals. Bookmark the permalink.

© 2005-2019 Parker Waichman LLP ®. All Rights Reserved.