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BLA for Denileukin Diftitox in CTCL Resubmitted to FDA

By Blood Cancers Today Staff Writers - Last Updated: March 17, 2024

The Biologics License Application (BLA) for denileukin diftitox (LYMPHIR) has been resubmitted by Citius Pharmaceuticals, Inc. after the company addressed deficiencies in the original application package that were specified in a complete response letter from the US Food and Drug Administration (FDA).

Specifically, the BLA resubmission package includes improved product testing and manufacturing control processes. The FDA did not identify any issues with safety or efficacy and did not request additional trials, according to a release from Citius.

Denileukin diftitox is an interleukin (IL)-2-based immunotherapy for patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. The agent binds to IL-2 receptors and releases diphtheria toxin fragments into cells that inhibit protein synthesis.

Denileukin diftitox received orphan drug designation from the FDA for CTCL in 2013 and for peripheral T-cell lymphoma in 2011.

Original Source: BLA for Denileukin Diftitox in CTCL Resubmitted to FDA | Blood Cancers Today

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