CAR T-cell Therapy Application for Large B-cell Lymphoma Remains Under FDA Review
The biologics license application lisocabtagene maraleucel in adult patients with relapsed/refractory large B-cell lymphoma following at least 2 previous therapies continues to be under regulatory review by the FDA.
The biologics license application (BLA) for the CAR T-cell product lisocabtagene maraleucel (liso-cel) in adult patients with relapsed/refractory large B-cell lymphoma following at least 2 previous therapies continues to be under regulatory review by the FDA, and a decision on the application has not yet been reached.1 A new action date for the application has yet to be provided by the regulatory agency. Bristol Myers Squibb announced that it will continue to work with the FDA to support the ongoing review of the BLA.
Moreover, because the approval of the product did not occur by December 31, 2020, 1 of the 3 milestones required for the payment of the Bristol Myers Squibb Contingent Value Right (CVR) had not been met. As such, on January 1, 2021, the CVR Agreement, pursuant to which the CVRs were delivered, underwent automatic termination in accordance with its terms. Moreover, the CVRs are no longer eligible for payment under the CVR Agreement, and thus, the CVRs will no longer trade on the NYSE.
Previously, in November 2020, the pharmaceutical company announced that the review of the BLA for liso-cel would be delayed because the FDA had not been able to conduct an inspection of a third-party manufacturing facility based in Texas during the review cycle in light of travel restrictions that were put into place in response to the coronavirus disease 2019 pandemic.2