Bristol-Myers' CAR-T gets priority review, mid-August PDUFA date

The FDA has accepted Bristol-Myers Squibb’s lisocabtagene maraleucel for priority review, setting the stage for a mid-August decision on whether to approve the CAR-T therapy. Bristol-Myers arrives at the FDA with data to suggest the cell therapy can hold its own against Gilead’s Yescarta and Novartis’ Kymriah.