The U.S. Food and Drug Administration (FDA) has granted orphan-drug designation (ODD) to Zandelisib, a drug produced in collaboration between MEI Pharma and Kyowa Kirin Inc for the treatment of follicular lymphoma (FL). Developed as a once-daily, oral investigational treatment for patients diagnosed with B-cell malignancies, Zandelisib was previously given Fast Track designation for patients with relapsed or refractory follicular lymphoma, acting as a selective PI3Kδ inhibitor. As the most common indolent lymphoma, FL forms on B cells and presents as a chronic, slowly progressing disease. As a late-stage pharmaceutical company, MEI Pharma is committed to creating novel therapeutic treatments that are both unique and address unmet patient needs. Working in conjunction with MEI Pharma, Kyowa Kirin is dedicated to using innovative science combined with research and engineering expertise to create and provide novel medicines to address the needs of patients across an array of therapeutic areas.
Read more here.