Drugs / Daromun
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT03567889 | Sep 2018 → Dec 2027 expected | melanoma | Philogen S.p.A. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2025-06-24 | Philogen S.p.A. | Regulatory Philogen Provides Update on Marketing Authorization Application for Nidlegy™ in the European Union philogen.com ↗ |
| 2024-07-04 | Philogen S.p.A. | Regulatory Submission of NidlegyTM Marketing Authorization Application Validated by EMA philogen.com ↗ |
| 2024-06-04 | Philogen S.p.A. | Regulatory Richiesta di autorizzazione all’immissione in commercio per il prodotto Nidlegy™ sottomessa all’EMA philogen.com ↗
La sottomissione della richiesta dell’AIC si basa sui dati clinici dello studio di Fase 3 PIVOTAL (PH-L19IL2TNF-02/15), i cui risultati primari sono stati presentati adASCO 2024 e sullo studio di Fase 2 (PH-L19IL2TNF-02/12). |
| 2024-06-04 | Philogen S.p.A. | Regulatory Nidlegy™ Marketing Authorization Application Submitted to EMA philogen.com ↗ |
| 2024-05-31 | Philogen S.p.A. | Results Risultati dello studio clinico di Fase III PIVOTAL di Nidlegy nel melanoma da presentare all’ASCO 2024 philogen.com ↗
Lo studio di fase III PIVOTAL (NCT02938299) ha dimostrato un beneficio statisticamente e clinicamente significativo del neoadiuvante Nidlegy nel melanoma localmente avanzato completamente resecabile. |
| 2024-05-31 | Philogen S.p.A. | Results Results of the Phase III PIVOTAL trial of Nidlegy in melanoma to be presented at ASCO 2024 philogen.com ↗
PIVOTAL (NCT02938299) Phase III trial demonstrated statistically significant and clinically meaningful benefit of neoadjuvant Nidlegy in fully resectable locally advanced melanoma |
| 2023-10-16 | Philogen S.p.A. | Results Nidlegy™ Phase III PIVOTAL trial meets the study’s primary objective in patients with locally advanced fully resectable melanoma (Price Sensitive) philogen.com ↗ |
| 2023-10-16 | Philogen S.p.A. | Results Nidlegy™ ha raggiunto positivamente l’obiettivo primario dello studio di Fase III PIVOTAL in pazienti con melanoma localmente avanzato completamente resecabile (Price Sensitive) philogen.com ↗
Nidlegy™ ha raggiunto positivamente l'obiettivo primario dello studio di Fase III PIVOTAL dimostrando un miglioramento statisticamente e clinicamente significativo della Sopravvivenza Libera da Ricorrenza in pazienti con melanoma localmente avanzato completamente resecabile |
| 2018-07-18 | Philogen S.p.A. | Regulatory Philogen Receives Orphan Drug Designation for the Treatment of Melanoma philogen.com ↗ |
| 2017-10-12 | Philogen S.p.A. | Regulatory Philogen announces authorization from FDA of a pivotal registration trial in USA for the treatment of resectable melanoma philogen.com ↗
Philogen S.p.A. (www.philogen.com), a privately owned biotechnology company, today announced approval by Food and Drugs Administration (FDA) of an IND for a Phase 3 registration trial with investigational melanoma drug DAROMUN (L19IL2 + L19TNF). |
All press releases naming this drug 10 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Daromun | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03567889 ↗ |
| Action | Deplete | “preferentially target tumor cells, resulting in direct destruction” PMID 31538818 ↗ Sep 2019 |
| Modality | Protein / enzyme biologic | “Daromun, an intralesional immunocytokine” PMID 31538818 ↗ Sep 2019 |
| Route | Other | “Patients will receive intratumoral administrations into injectable cutaneous, subcutaneous, and nodal tumors of Daromun once weekly for up to 4 weeks.” NCT03567889 ↗ |