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‘Poor Quality’ Submission: CellTrans’ Lantidra BLA Marked By Missing And Incongruent Data

 
• By Sue Sutter

FDA's review of documents and source data files to assess product efficacy and subject safety was complicated by missing and inconsistent data, the clinical reviewer said, concluding there was insufficient data monitoring during clinical studies or in preparing the documents for regulatory submission.

Drug Review Profile: Lantidra
The FDA had to look beyond the missing and inconsistent data in the Lantidra BLA. • Source: Pink Sheet/Shutterstock

The US Food and Drug Administration had to navigate a biologics license application of poor quality in its review and approval of CellTrans, Inc.’s cellular therapy Lantidra (donislecel-jujn) for treatment of type 1 diabetes.

“The applicant’s submission contained the elements required to support filing of the BLA,” clinical reviewer Patricia Beaston said in her...

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