As some analysts had fretted about, the FDA was unable to schedule an inspection of one of the manufacturing sites that was to be used for the production of liso-cel, their CAR-T picked up in the buyout, which was originally developed by Juno. As a result, Bristol Myers reported today that the FDA will not meet its PDUFA date today.
And it has no idea when that inspection can be scheduled for.
From their statement:
The FDA was unable to conduct an inspection of a third-party manufacturing facility in Texas during the current review cycle due to travel restrictions related to the COVID-19 pandemic. Therefore, the FDA is deferring action on the application until the inspection can be completed. The application remains under review. The FDA did not provide a new anticipated action date.
The liso-cel OK has to arrive by Dec. 31 — just 45 days from now — or their CVR is toast. And that’s not a lot of time for an agency that hasn’t shown much sense of urgency related to liso-cel, once one of the leading CAR-Ts in development, alongside rivals from Novartis and Kite — now part of Gilead.
Liso-cel was originally assigned a priority review at the FDA.
Remember that during last-minute buyout negotiations, Bristol Myers CEO Giovanni Caforio insisted that Celgene replace cash on the table with a $9 CVR tied to the approval of 3 drugs by certain dates. This is the second FDA delay for liso-cel and ide-cel got slapped with a refuse-to-file. That drug has until the end of Q1 next year to make good.
At one point Juno signaled their belief that an approval for liso-cel could arrive in 2018, but once in the hands of Celgene, there were repeated development delays.