Orphan drug designation offers significant benefits to Hana Biosciences, including financial incentives and market exclusivity for a period of seven years.
Hana is currently conducting a Phase II clinical trial to assess the efficacy of Marqibo as determined by disease control rate (complete response, partial response and durable stable disease) in patients with metastatic malignant uveal melanoma.
Anne Hagey, vice president and chief medical officer of Hana, said: “We are pleased to have received orphan designation from the FDA for Marqibo in metastatic uveal melanoma, a cancer with a clear unmet medical need. We believe this recognizes the need to pursue these difficult disease indications.”