March 03, 2021
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FDA grants fast track status to OKN-007 for diffuse intrinsic pontine glioma
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OKN-007 received FDA fast track designation for the treatment of children with diffuse intrinsic pontine glioma, or DIPG, according to a press release from the agent’s manufacturer.
DIPG, a rare brainstem cancer that occurs in children and young adults, has limited treatment options. Approximately 90% of those diagnosed with DIPG die within 2 years, and 5-year survival is less than 1%.
OKN-007 (Oblato, GtreeBNT Co.) is under investigation in combination with temozolomide for the treatment of patients with newly diagnosed and recurrent glioblastoma multiforme. The agent will be evaluated for DIPG in a phase 1/phase 2 trial later this year.
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