Celgene analysts are skeptical. After researchers stopped a Revlimid trial to investigate new cancers that developed in patients using the blood-cancer drug, it suggested those secondary cancers were common in multiple myeloma patients. But now, analysts are saying that some of the new cancers aren't so ordinary.
Celgene has been working to develop Revlimid as a first-line treatment and as a maintenance therapy for multiple myeloma patients. It asked European regulators last month to approve those new indications. Obviously, maintenance therapy would require long-term use of Revlimid. But last week, investigators in a French trial looking at long-term use stopped dosing patients.
Celgene responded by saying that the "observational bias" in the study contributed to the stats on new cancers; the cancers found often arise in multiple myeloma patients; and other treatments used by these patients have been linked to new cancer cases.
Bank of America-Merrill Lynch analyst Rachel McMinn said the study was stopped because half of the new cancers weren't typical, and investigators believe they were caused by Revlimid, Dow Jones reports. Sanford Bernstein's Geoffrey Porges also pooh-poohed Celgene's "observational bias" explanation for the increased number of cancers, saying it's "probably incorrect."
Porges said in a note to investors that the study data probably won't tip the balance against approval of the new indications. "The risk benefit of Revlimid maintenance still seems overwhelming, and sufficient to justify approval, reimbursement and use," Porges wrote, as quoted by the news service, "but the trickle-out disclosure that is contrary to Celgene's statements is concerning."
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