Drugs / DARZALEX FASPRO®
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (6) | US (FDA) | DARZALEX FASPRO | — | 2021-01-11 – 2026-01-27 | fda.gov ↗ |
| Approved | US (FDA) | DARZALEX FASPRO | — | 2020-05-01 | fda.gov ↗ |
Trials 0
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Comparator or background therapy2 trials | ||||||
| Phase 1 | NCT06371534 Comparator | Apr 2024 → Apr 2025 | neoplasm | Qilu Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT06742138 Comparator | Jan 2025 → Dec 2027 expected | plasma cell myeloma | Qilu Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | DARZALEX FASPRO | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06371534 ↗ |
| Route | Subcutaneous | “given 1800 mg subcutaneously” NCT06742138 ↗ |