FDA Wants More Data Before Approving Alemtuzumab for MS
“If the FDA was going to make this decision a priori given the lack of blinding of the study, then I’m concerned that they ethically allowed my patients to take the risk and the sacrifices that they did to enroll and maintain themselves in this study,” Dr. LaGanke said. “And the results were no surprise from the phase II study; so at the end of the day, this has been the most effective treatment we’ve had for relapsing MS, as far as several outcomes, of any of our approved medications, and there was no novel safety signal. It wasn’t that there were differences in the results that would have created a difference in their opinion. So that really concerns me. I feel badly for my patients who went through all of that for naught because of the trial design, because the trial could have been halted from the get go.”
Dr. Henson echoed Dr. LaGanke’s empathy for her own MS patients. “More than anything else, I feel really badly for my patients who have been waiting for this drug because truly it is now back to the drawing board.”
Dr. Carter notes that there is a segment of the MS population—those who are positive for the JC virus antibody and are considered at increased risk for progressive multifocal leukoencephalopathy (PML) with natalizumab (Tysabri) therapy—for whom the options are slim to none.
“There are a lot of patients for whom alemtuzumab is not the right drug,” said Dr. Henson. “It is not as though I am going to recommend this drug to all my patients.” She notes, however, that she has patients with severe MS who have no other options that they can use at this point. “Where I would use this drug is in patients with aggressive disease who have failed the first-line or second-line therapies. It is most likely going to be a third-line therapy for patients who have failed the injectables, failed the orals, and plus or minus failed natalizumab.”
Available Elsewhere, But Not Here
Alemtuzumab was approved by the FDA in 2001 and marketed as Campath for B-cell chronic lymphocytic leukemia in the United States. But in September 2012, the company took Campath off the market and is providing it free of charge to leukemia patients in a distribution program. Alemtuzumab has been approved for MS in the European Union, Canada, and Australia. “It is disappointing that we in this country do not have access to this medication,” said Dr. LaGanke.
“The implications of this drug being approved in other countries,” Dr. Henson added, “are that we are going to be forced to try to find some way to get these patients the medication, get it paid for, and then figure out how to monitor these patients. That’s just crazy.”
—Elizabeth Mechcatie & Glenn Williams
