Among other concerns raised by panelists were the age of the patients in the study, which was a median of 63 years at enrollment, about 10 years younger than the median age of patients at diagnosis, since toxicity could be worse in older patients, they pointed out.
“While we are disappointed with the committee’s recommendation, we will continue to work with the FDA as it evaluates the application,” Bruno Strigini, Pharm.D., president of Novartis Oncology, said in a statement issued after the vote. The drug is also under review in the European Union and Japan.
The FDA usually follows the recommendations of its advisory panels. The FDA is expected to make the decision this month. No panel members had conflicts of interest to disclose.
Bortezomib was approved as third-line and second-line therapy for multiple myeloma in 2003 and 2005, respectively, and in 2008 it was approved for previously untreated multiple myeloma.