Mocetinostat Designated Orphan Drug for Diffuse Large B-Cell Lymphoma

Mirati Therapeutics announced that the FDA has granted Orphan Drug designation to mocetinostat, a spectrum selective HDAC inhibitor, for diffuse large B-cell lymphoma (DLBCL).

Mocetinostat is being developed as a single agent treatment in patients with diffuse large B-cell lymphoma and bladder cancer with specific genetic mutations in Histone Acetyl Transferases (HATs). Mocetinostat reverses aberrant acetylation resulting from HAT mutations and is predicted to halt tumor progression and reduce tumor burden in patients. Mocetinostat is also being studied in Phase 2 clinical trials in combination with Vidaza (azacitidine; Celgene) as a treatment for intermediate and high-risk myelodysplastic syndrome (MDS). In addition to the ongoing Phase 2 clinical trials, mocetinostat has completed 13 clinical trials in more than 400 patients with a variety of hematologic malignancies and solid tumors.

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Previously in June, mocetinostat was granted Orphan Drug designation by the FDA for the treatment of MDS.

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