The trial, of Xpovio, showed a positive increase in progression-free survival in patients with second-line disease. Xpovio's accelerated approval last year for heavily pretreated patients attracted controversy from the myeloma physician community.
Several FDA approvals - including ones going against AdCom votes - have attracted controversy and a perception of lowered standards at the agency. However, some see a long-standing institutional tension between patient protection and speedy approval, with the latter having a net positive effect.
The future looks bright for the integrated specialty pharmacy model – for health systems, providers, and most importantly, for patients.
Although the agency goes against about one-fifth of AdCom recommendations, a study published Sunday only found one reliable variable predicting when that would happen.
In a series of tweets, a myeloma expert called the FDA accelerated approval of Karyopharm's Xpovio "baffling" and "incorrect" and the drug's $22,000 monthly price tag "outrageous." A member of ODAC also agreed that the drug should not have been approved so early. The company defended the drug and its pricing.
Data from the ongoing Phase III study, which have not been publicly disclosed, influenced the decision to approve the drug, Xpovio, in "penta-refractory" myeloma.