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.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
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.
Shares of the company were down more than 12 percent in premarket trading on the Nasdaq Wednesday. They had already fallen 46 percent Friday after the release of AdCom briefing documents.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.