The Oncologic Drugs Advisory Committee voted 12-0 that the benefit-risk profile of belantamab mafodotin supported the drug. The vote came despite concerns expressed by the FDA in briefing documents ahead of the ODAC meeting, particularly with regard to ocular toxicity.
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.
By reducing administrative burden and redesigning workflows around human needs, it creates space for what matters most: connection between clinicians and patients.
A company spokesperson said the company was working to address the agency's concerns about the drug, quizartinib, for FLT3-mutated acute myeloid leukemia.
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.