The First FDA-Approved Therapy for DIPG: A Milestone of Hope

We are thrilled to share some groundbreaking news that marks a significant step forward in the fight against DIPG. The FDA has granted accelerated approval for ONC201 (now Modeyso™) for the treatment of recurrent H3 K27M-mutant diffuse midline glioma (DMG), including DIPG. This is the first-ever FDA-approved therapy for this devastating disease, and it would not have been possible without your support.

Your belief in our mission and your unwavering generosity fueled the funding for the PNOC-022 trial and the compassionate use of ONC201. Mithil Prasad Foundation is proud to have been one of the early funders and supporters (along with foundations like ChadTough Defeat DIPG Foundation) of the DMG-ACT (Diffuse Midline Glioma – Adaptive Combinatorial Trial) initiative from PNOC (Pediatric Neurology Oncology Consortium), which included the pivotal PNOC-022 trial. Real-world data from trials like PNOC-022, along with expanded use programs, significantly strengthened the growing body of evidence supporting ONC201, playing a key role in its FDA approval. This is a victory for our entire community, and we owe it to each of you who contributed to making this happen.

However, this approval is not the end game—it’s just the warm-up. While this is an extraordinary achievement, we still have a long road ahead in finding a cure for DIPG. We won’t stop until every child diagnosed with DIPG has access to effective treatments and ultimately, a cure. The journey continues, and we are so grateful to have you by our side.

Thank you for being a part of this historic moment and for your continued support in the battle against DIPG. Together, we are making real, life-changing progress for children and families affected by this disease.

With deepest gratitude,

Sarva Channarajurs,

Mithil’s Mom, President & Co-Founder, Mithil Prasad Foundation

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