FDA record · Cancer
What FDA's own documents say about Modeyso: what it is approved for, the trials FDA reviewed, the results it reported and the risks on the label.
“MODEYSO is a protease activator indicated 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.”
Prescribing information, original approval · PDF p. 1 · fda.gov ↗
| Trial | ClinicalTrials.gov | Phase | Mentions | Documents |
|---|---|---|---|---|
| BIO-101 | not given | 7 | 1 of 10 |
Mentions: how many sentences across the FDA documents name the trial. NCT ids are read from the documents or, where they give none, matched on ClinicalTrials.gov by the trial's name or protocol code.
Sentences from FDA's reviews that give an endpoint's p-value, effect or confidence interval, those reporting a treatment effect first.
overall survival
“RANO 2.0 response was significantly associated with OS as a time-varying covariate in a multivariate Cox Proportional Hazards model (hazard ratio 0.22 [95% CI: 0.08-0.58]; p=0.0024).”
Multi-disciplinary Review · PDF p. 130 · fda.gov ↗
95%p=0.0024
“The most common adverse reactions (>=20%) were fatigue, headache, vomiting, nausea, and musculoskeletal pain.”
Prescribing information, original approval · PDF p. 6 · fda.gov ↗
“• The recommended dose in adult patients is 625 mg orally once weekly.”
Prescribing information, original approval · PDF p. 1 · fda.gov ↗
“• The recommended dose in pediatric patients weighing >=10 kg is based on body weight (see Table 1).”
Prescribing information, original approval · PDF p. 1 · fda.gov ↗
| Document | Date | Pages | Copy | sha256 |
|---|---|---|---|---|
| Prescribing information, original approval219876s000lbl.pdf | August 6, 2025 | 26 | 6f58748b602e | |
| Approval letter219876Orig1s000ltr.pdf | August 7, 2025 | 9 | 7801545f8d62 | |
| Administrative Correspondence219876Orig1s000AdminCorres.pdf | September 2, 2025 | 31 | 5d6ae04decfd | |
| Approval Letter219876Orig1s000Approv.pdf | September 2, 2025 | 12 | ba9c7805b339 | |
| Chemistry Review219876Orig1s000ChemR.pdf | September 2, 2025 | 38 | 2a0733562ce0 | |
| Multi-disciplinary Review219876Orig1s000MultidisciplineR.pdf | September 2, 2025 | 237 | 80dd06ef2366 | |
| Proprietary Name Review219876Orig1s000NameR.pdf | September 2, 2025 | 29 | 92f27914ac61 | |
| Officer/Employee List219876Orig1s000OEList.pdf | September 2, 2025 | 2 | 154937106601 | |
| Other Reviews219876Orig1s000OtherR.pdf | September 2, 2025 | 62 | 5660ce3418a9 | |
| Risk Assessment / REMS Review219876Orig1s000RiskR.pdf | September 2, 2025 | 11 | e212a926a378 |
Checked against FDA's copies on September 30, 2026. The sha256 is the fingerprint of the file that was read: download it from fda.gov and compare. Quotes come from the text of each file as read; pages FDA stored as images were read by OCR and are marked.
Generated automatically (auto): the trials, names and dates are drafted from the documents by rules, with no language model; see the method.