FDA Grants Orphan Drug Designation To Mirati's Lymphoma Drug Mocetinostat

(RTTNews) - Mirati Therapeutics, Inc. (MRTX), a developer of oncology drugs, Monday said the U.S. Food and Drug Administration has granted orphan drug status to mocetinostat for treating diffuse large B-cell lymphoma or DLBCL.

DLBCL, which is the most common type of non-Hodgkin lymphoma, occurs mainly in older people.

Mocetinostat, a spectrum selective HDAC inhibitor, was granted orphan drug status earlier this year to treat myelodysplastic syndrome. The company is now seeking orphan drug designation bladder cancer with specific genetic alterations.

At this time, the drug is also undergoing Phase 2 clinical studies in combination with Vidaza as a treatment for intermediate and high-risk MDS, with the results scheduled to be announced by the end of this year.

Mocetinostat has already gone through 13 clinical trials involving over 400 patients with a range of hematologic malignancies and solid tumors.