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FDA Grants Orphan Drug Designation to Galinpepimut-S for Treatment of Multiple Myeloma

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The U.S. Food and Drug Administration (FDA) recently granted Orphan Drug designation to galinpepimut-S for the treatment of multiple myeloma. The drug is licensed from Memorial Sloan Kettering Cancer Center and targets the Wilms tumor 1 (WT1) protein, which is present in an array of tumor types. 

“We are delighted to receive this orphan drug designation as it underscores the great need for innovative, effective treatments for this rare cancer, and recognizes the potential benefits that [galinpepimut-S] may provide for patients with multiple myeloma,” said Angelos Stergiou, MD, ScD(hc), President and Chief Executive Officer of SELLAS Life Sciences. “Receiving orphan drug designation for the treatment of multiple myeloma is a significant regulatory milestone in the development of [galinpepimut-S]. We have reported a median progression-free survival of 23.6 months in the high-risk multiple myeloma disease setting, compared to historically inferior outcomes in such a patient cohort of around 12 months, and [galinpepimut-S] stimulated time-dependent and robust CD4-positive T-cell or CD8-positive T-cell immune responses as well as multifunctional cross-epitope T-cell reactivity.”

Galinpepimut-S has also received orphan drug designation for the treatment of acute myeloid leukemia and malignant pleural mesothelioma.

The FDA's Office of Orphan Drug Products grants orphan status to support development of medicines for safe and effective treatment, diagnosis, or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. Orphan Drug designation may provide certain benefits, including a 7-year period of market exclusivity if the drug is approved, tax credits for qualified clinical trials, and an exemption from FDA application fees.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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