Moreover, half of the patients in each group were receiving corticosteroids at baseline, the FDA spokesperson said. More patients in the bevacizumab group “were able to achieve clinically meaningful reductions in daily corticosteroid use compared with those in the lomustine arm (64% vs 36%) and 20% of patients receiving bevacizumab discontinued corticosteroids for [at least] 12 weeks,” the FDA spokesperson wrote, who replied by way of a Center for Drug Evaluation and Research (CDER) press account. But in the New England Journal of Medicine paper summarizing the results of that trial, the authors wrote that “the addition of bevacizumab in the current trial did not result in reduced use of glucocorticoids.”4
Furthermore, a 2017 press release from Roche, the makers of bevacizumab, said daily corticosteroid use could be completely stopped in 23% versus 12% of those in the bevacizumab arm compared with those in the other arm, respectively.3 When Cancer Therapy Advisor inquired about where to find the data on corticosteroid use reduction that were initially provided by the agency, the FDA representative told this publication that the rates of steroid reduction cited by the agency were “from the review,” and then directed the editors to file a Freedom of Information Act (FOIA) request in order to see those data from the seemingly nonpublicly available review.
The FDA appears to be basing their decision to change the status of the drug for glioblastoma to full approval on the finding about progression-free survival and the finding that more patients were able to stop corticosteroid treatment in the bevacizumab plus lomustine arm compared with the lomustine monotherapy arm, Gill said. “This is a confusing crossroads: the results of this large [randomized controlled trial] seem negative, but the FDA is backing this drug for this indication,” Gill said. “This is where clinicians must step up and do their own research to make an informed decision.”
The other 2 trials listed as reversals in the new analysis were related to the use of bevacizumab for newly diagnosed glioblastoma. The authors of the new analysis noted that bevacizumab “was being used off-label for treating this cancer, despite the $100,000 a year price tag.”1 In one trial, 637 patients with newly diagnosed glioblastoma were randomly assigned to receive bevacizumab or placebo during week 4 of radiotherapy.5 The 2 coprimary end points were a 25% reduction in the risk of death and a 30% reduction in the risk of progression or death in the bevacizumab group.