Dr. Michael Prados discusses PNOC's role in the historic FDA approval of Tovorafenib (DAY101)

Today we are celebrating a landmark development for pediatric brain cancer research and treatment. Today's new treatment approval by the FDA is proof of what is possible when doctors, scientists, researchers, biopharma, and philanthropists truly collaborate and work together. This is a victory for kids and their families fighting pediatric low-grade gliomas. The FDA approval of Tovorafenib (DAY101) is a significant advancement and is a direct result of PNOC's clinical trials! This approval marks a significant milestone as the first and only FDA-approved medicine for children with BRAF fusions or rearrangements in pediatric low-grade glioma.

Before Tovorafenib, there was no standard of care for these children. Pediatric low-grade glioma is the most common brain tumor diagnosed in children, with patients suffering profound tumor- and treatment-associated morbidities that can impact their life trajectory. BRAF is the most commonly altered gene in pediatric low-grade glioma, with up to 75 percent of children having a BRAF alteration.

"Pediatric low-grade glioma is a chronic and relentless cancer that can devastate children and their families, often stealing their vision, balance and speech. PNOC is proud of our role in this collaborative achievement and remains committed to advancing research, enhancing treatment options, and improving the lives of children affected by brain tumors. We extend our heartfelt gratitude to all the patients, families, researchers, and healthcare professionals who contributed to the success of PNOC014 and FIREFLY-1/PNOC026 and the development of Tovorafenib (DAY101).” said Dr. Sabine Mueller, PNOC’s scientific Co-Founder and Project Lead.

Support PNOC's research: https://www.pnocfoundation.org

Learn more about PNOC: https://pnoc.us

Read the PNOC Foundation press release: https://www.prnewswire.com/news-relea...

Read the DayOne Press Release: https://ir.dayonebio.com/news-release...

Read the FDA Press Release: https://www.fda.gov/drugs/resources-i...