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Bristol Myers Squibb statement on status of Liso-cel application to FDA for large B cell lymphoma.

Read time: 1 mins
Published:5th Jan 2021
Bringing liso-cel to patients with 3L+ Large B Cell Lymphoma is a top priority for Bristol Myers Squibb. With the lapsing of the PDUFA date, the application remains under review by the FDA. Since the last update on November 16, 2020, the following has occurred:The inspection of the viral vector 3rd party manufacturing plant took place from December 3, 2020 to December 10, 2020. Lonza and BMS expeditiously responded to observations received at the close of the inspection within 8 days. BMS received Information Requests which were also rapidly responded to and there are currently no outstanding Information Requests at this time. We will continue to work closely with the FDA to bring this therapy to patients as quickly as possible.
Condition: Diffuse Large B Cell Lymphoma
Type: drug

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