Jazz Pharmaceuticals’ Modeyso recommended for glioma by NCCN Guidelines

Jazz Pharmaceuticals (JAZZ) announced that Modeyso – dordaviprone – is recommended by the National Comprehensive Cancer Network, or NCCN, Clinical Practice Guidelines in Oncology as a category 2A single-agent treatment option for pediatric and adult patients with recurrent or progressive diffuse high-grade glioma harboring an H3 K27M mutation. Modeyso was granted accelerated approval by the FDA on August 6 for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the Phase 3 ACTION confirmatory trial. The guidelines present expert recommendations for cancer screening, diagnosis and treatment, as well as cancer care options, and are utilized in cancer treatment decision-making to drive positive patient outcomes. NCCN is a not-for-profit alliance of 33 cancer centers devoted to patient care, research and education dedicated to defining and advancing effective, equitable, accessible and quality cancer care and prevention. The FDA approval of Modeyso was based on an integrated efficacy analysis of 50 patients with recurrent H3 K27M-mutant diffuse midline glioma, selected from five open-label clinical studies based on pre-specified eligibility criteria. The safety of Modeyso was evaluated in 376 adult and pediatric patients with glioma across four open-label clinical studies. Serious adverse reactions occurred in 33% of patients. The most common adverse reactions in patients who received Modeyso were fatigue, headache, vomiting, nausea and musculoskeletal pain.