FDA Priority Review for Potential Expanded Approval of Epkinly

AbbVie and Genmab have been granted priority review by the U.S. Food and Drug Administration for their application seeking expanded approval of Epkinly in certain patients with hard-to-treat follicular lymphoma.

Application Details

The application submitted by the companies covers adults with relapsed or refractory follicular lymphoma after two or more lines of therapy. This designation by the FDA highlights the potential of Epkinly to provide significant improvements in the treatment of this serious disease, leading to a shorter review period. The target action date for the application has been set for June 28.

First of its Kind Treatment

If approved, Epkinly will become the first and only subcutaneous bispecific antibody available to treat adults with relapsed or refractory follicular lymphoma after two lines of prior therapy. This innovative approach represents a promising advancement in the field of oncology.

Collaboration and Previous Approvals

AbbVie, based in North Chicago, Illinois, and Genmab from Copenhagen are collaborating on the development of Epkinly under a partnership established in 2020. The drug was previously approved by both the FDA and European regulators for the third-line treatment of adults with relapsed or refractory diffuse large B-cell lymphoma.

For more information on this groundbreaking development, stay tuned for updates.

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