CAR-T Cell Therapy Product for Relapsed/Refractory Large B-Cell Lymphoma Still Under FDA Review


The FDA has not yet reached a decision on an application for the approval of a CAR-T cell therapy product for the treatment of relapsed/refractory large b-cell lymphoma and, according to Bristol Myers Squibb, a new action date for the decision has not been set.

The Food and Drug Administration (FDA) is still reviewing the biologics license application for the CAR-T cell product lisocabtagene maraleucel for the treatment of adults with relapsed/refractory large B-cell lymphoma following at least two previous therapies, according to the product’s manufacturer, Bristol Myers Squibb.

The agency has not yet reached a decision on the application and, according to the manufacturer, a new action date for the application has not been set.

A biologics license application is filed to the FDA by drug manufacturers as a request to begin introducing, delivering or marketing a product for public use and typically could lead to a drug being approved for public use.

The agency was set to make an initial decision on the application in August 2020, but announced in May that it would extend the review period for the CAR-T cell product by three months to allow it to analyze more data from the manufacturer. Then in November, Bristol Myers Squibb announced that the review would be delayed again as the FDA was not able to inspect a manufacturing facility during the time of the review cycle because of travel restrictions as a result of COVID-19.

The manufacturer announced that it is continuing to work with the FDA to support the ongoing review of the application.

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