The FDA has asked Bristol Myers Squibb and bluebird to resubmit an application for a CAR-T cell therapy.
According to the companies, the agency had concerns about the manufacturing process of the therapy, but did not ask for more clinical data. The therapy, called ide-cell, was developed to treat multiple myeloma. If the FDA ultimately gives it the greenlight, it will be the first CAR-T cell therapy approved for the indication.
Only two other CAR-T cell therapies have been approved by the FDA — Novartis’ Kymriah and Kite/Gilead’s Yescarta, which both treat different types of blood cancers. Although CAR-T cell therapies have shown impressive response rates for patients, they have also been mired in manufacturing challenges. In December, Novartis reported that it is unable to ship Kymriah to patients 10 percent of the time either because of out-of-specification issues or manufacturing failures.
BSM picked up the therapy as part of its $74 billion takeover of Celgene. BSM said that it will now seek a priority review designation as it prepares to re-submit its application for ide-cell.
Ide-cell is also one of three treatments with a contingent value right for Celgene investors, who will receive $9 a share if the therapies receive an approval before their designated deadlines.
Read the Reuters report.
