Modeyso^™ (dordaviprone)

FOR IMMEDIATE RELEASE:

Onco360 adds Modeyso™ (dordaviprone) to portfolio of Oncology and Rare Cancer therapies as a National Specialty Pharmacy Provider  

Louisville, KY — August 7, 2025 — Onco360^®, the nation’s leading independent Specialty Pharmacy, has been selected as a pharmacy partner by Jazz Pharmaceuticals for Modeyso™ (dordaviprone). It is indicated for the treatment of adult and pediatric patients one year of age and older with diffuse midline glioma harboring an H3 K27M-mutation with progressive disease following prior therapy.¹ This indication was approved based on five open-label, non-randomized clinical trials conducted in the U.S. (ONC006 [NCT02525692], ONC013 [NCT03295396], ONC014 [NCT03416530], ONC016 [NCT05392374], and ONC018 [NCT03134131]).¹ 

“Onco360 is grateful for the opportunity to add Modeyso™ to our expansive portfolio of cancer and rare disease therapies as the first and only FDA-approved treatment for pediatric and adult patients with diffuse midline glioma”, said Benito Fernandez. “We are proud and humbled to be part of this innovative treatment in support of patients, caregivers and families impacted by this devastating disease.”

Dordaviprone is a protease activator of the mitochondrial caseinolytic protease P (ClpP) and inhibits dopamine D2 receptor (DRD2). In vitro, dordaviprone activates the integrated stress response, induces apoptosis, and alters mitochondrial metabolism, leading to restored histone H3 K27 trimethylation in H3 K27M-mutant diffuse glioma.¹ 

The efficacy of Modeyso was evaluated in an integrated efficacy population of 50 adult and pediatric patients with recurrent H3 K27M-mutant diffuse midline glioma enrolled across five open-label, non-randomized clinical trials.¹ The primary outcome was overall response rate (ORR) of 22% (95% CI: 12,36). The trial also demonstrated a duration of response of 10.3 months (95% CI: 7.3, 15.2) with 73% maintaining their response for at least six months and 27% for at least 12 months.¹

Dordaviprone demonstrated manageable safety and tolerability adverse events. The most common adverse reactions (≥20 %; all causality) experienced with dordaviprone were fatigue, headache, nausea, vomiting, and musculoskeletal pain.¹

Please see the full Prescribing Information for Modeyso.

 

Media Contact: Benito Fernandez, Chief Commercial Officer

[email protected]

516-640-1332

 

References:

¹Modeyso™ (Dordaviprone) [Package Insert]. Palo Alto, CA. Jazz Pharmaceuticals. 2025.