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FDA grants orphan drug designation to cobomarsen, for the treatment of T-cell lymphoma

Jul 24, 2020

On July 23, 2020, the U.S. Food & Drug Administration (FDA) granted orphan drug designation to cobomarsen (MRG-106), for the treatment of T-cell lymphoma.

Cobomarsen is an inhibitor of microRNA-155 (miR-155). Overexpression of miR-155 is associated with poor prognosis in a variety of T-cell lymphomas and several other blood cancers. In 2017, the FDA and the European Medicines Agency (EMA) granted orphan drug designation to cobomarsen for the treatment of mycosis fungoides-type cutaneous T-cell lymphoma (CTCL).

Cobomarsen is currently under investigation in two clinical trials, a phase II trial ( NCT03837457 ) for CTCL and a phase I trial ( NCT02580552 ) for adult T-cell leukemia/lymphoma (ATLL).  It has demonstrated promising results in patients with CTCL and ATLL, and it could be potentially used as a broad-based therapy for the treatment of other cancers with elevated levels of miR-155.

  1. GlobeNewswire. Cobomarsen receives orphan drug designation from the U.S. FDA for the treatment of T-cell lymphoma. https://www.globenewswire.com/news-release/2020/07/23/2066961/0/en/Cobomarsen-Receives-Orphan-Drug-Designation-From-the-U-S-FDA-for-the-Treatment-of-T-cell-Lymphoma.html. Published Jul 23, 2020. Accessed Jul 24, 2020.