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FDA grants orphan drug status to SL-701 for glioma treatment
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The FDA today granted orphan drug designation to SL-701 for the treatment of glioma, according to a press release from the drug’s manufacturer.
SL-701 (Stemline Therapeutics) is an enhanced immunotherapy that activates the immune system to kill malignant gliomas.
“We are pleased with the FDA’s decision to grant orphan drug designation to SL-701, as it provides Stemline with a number of benefits through development and commercialization of this novel therapy,” Eric K. Rowinsky, MD, Stemline’s chief medical officer and head of research and development, said in a press release. [Glioblastoma multiforme] is a highly aggressive disease with few effective treatment options and remains a major unmet need. Instead of targeting a single component of the cancer, SL-701 is designed to activate and direct the immune system against multiple targets overexpressed on glioma cells. We are very pleased about the high level of interest in the study from patients and clinicians alike.”
A phase 2 study is currently underway to evaluate antitumor activity of SL-701 in adults with second-line glioblastoma multiforme and additional studies are planned to evaluate SL-701 in pediatric high-grade glioma.