Vanessa's Comment:

SurVaxM is an off-the-shelf vaccine that stimulates an immune response against a tumor cell protein called survivin. The Phase 2b trial for newly diagnosed adult glioblastoma is ongoing (no longer recruiting), and there's also a Phase 1 trial currently recruiting for children with relapsed medulloblastoma, high grade glioma, ependymoma and newly diagnosed DIPG. SurVaxM received orphan drug status for treatment of adult GBM back in 2017, but the status has now been expanded in scope to include any malignant glioma in children or adults. This designation, given to drugs aimed at treating rare diseases, helps encourage drug development through incentives like tax credits and extended market exclusivity, but it does not speed up drug approval. We'd love to see an expanded access program offered for SurVaxM, but the cost would be significant. If any organizations or individuals are interested in partnering to help fund such a project, please let us know!


Posted on: 06/23/2024

FDA Expands Orphan Drug Designation for SurVaxM, Immunotherapy Developed at Roswell Park

 


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