Lumicell Inc.’s breast cancer imaging drug provides an important, if incremental, benefit that outweighs the manageable risks of anaphylaxis, a US FDA advisory panel concluded on 5 March.
‘Incremental’ Benefit Of Lumicell’s Cancer Imaging Drug Outweighs Manageable Risk, FDA Panel Says
Most advisory committee members supported approval of the breast cancer imaging product, but indicated labeling and advertising should be carefully crafted to avoid overhyping the likelihood patients experience a clinical benefit.
