FDA Halts Review of Application for Ide-cel for Advanced Multiple Myeloma
The U.S. Food and Drug Administration (FDA) issued a refusal to file letter for the biologics license application for idecabtagene vicleucel (ide-cel; bb2121) for patients with heavily pre-treated relapsed and refractory multiple myeloma, according to a press release.
The letter was issued after a preliminary review by the FDA determined additional detail was needed for the biologics license application to be considered complete.
Bristol Myers Squibb said in the press release they are planning to resubmit the application no later than the end of July 2020.
In March, Ide-cel was granted breakthrough therapy designation by the FDA.
Read the full press release here.