FDA expands orphan drug designation for Roswell Park's brain cancer immunotherapy

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FDA expands orphan drug designation for Roswell Park's brain cancer immunotherapy
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The U.S. Food and Drug Administration (FDA) has expanded orphan drug designation for SurVaxM, a brain cancer immunotherapy born in the labs of Roswell Park Comprehensive Cancer Center.

Roswell Park Comprehensive Cancer CenterJun 25 2024 The U.S. Food and Drug Administration has expanded orphan drug designation for SurVaxM, a brain cancer immunotherapy born in the labs of Roswell Park Comprehensive Cancer Center. The supplemental designation awarded to MimiVax Inc. now applies to SurVaxM as treatment for not just adult glioblastoma but a broader category of cancerous brain tumors: any malignant glioma in children or adults.

MimiVax first received orphan drug status for SurVaxM in August 2017, for treatment of adult glioblastoma. The supplemental designation greatly expands the potential for SurVaxM's use in other forms of pediatric and adult malignant gliomas. Gliomas are the most common type of cancer originating in the brain.

Work to develop the vaccine has been enabled by donations from numerous individuals and corporations to the Roswell Park Alliance Foundation, including support from events like the Ride for Roswell, which will see thousands of cyclists riding routes throughout Western New York and into Canada on June 22.

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