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Mirati Therapeutics Receives Orphan Designation for B-Cell Lymphoma Drug

In Regulation & Government by CecileLeave a Comment

The U.S FDA has Granted Mirati Therapeutics an Orphan Designation for a Drug to treat Diffuse Large B-Cell Lymphoma

The U.S FDA has Granted Mirati Therapeutics an Orphan Designation for a Drug to treat Diffuse Large B-Cell Lymphoma

On Monday the 11th of August, Mirati therapeutics announced that the FDA had granted their large B-cell lymphoma drug candidate, mocetionostat, an Orphan Drug Designation.

This coveted designation will give Mirati clinical trial tax incentives for the drug. If, after development, the drug receives orphan drug status, then it can be sold without competition for seven years.

The drug was also granted an orphan designation as a treatment for myelodysplastic syndrome (MDS), and the company hopes to also secure orphan drug designation for the drug to treat bladder cancer patients with particular genetic mutations.

Mocetinostat is being developed as a treatment for diffuse large B-cell lymphoma, as well as for bladder cancer in people that have genetic mutations in Histone Acetyl Transferase’s (HATs). The drug is able to reverse incorrect acetylation which occurs as a result of mutations in HATs. This is predicted to reduce tumour progression and size in patients.

We have identified genetic alterations in histone acetylation pathways (CREBBP and EP300) in approximately one third of DLBCL and bladder tumors. Nonclinical tumor models exhibiting these mutations are particularly responsive to mocetinostatDr. Charles Baum, president and CEO of Mirati

Read more about it here: Mirati Therapeutics Receives Orphan Designation from U.S. Food & Drug Administration for Mocetinostat in Diffuse Large B-Cell Lymphoma

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