Drugs / 131I-omburtamab
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | cns neuroblastoma with FOXR2 activation | 2022-03-31 | “During June 2020, we initiated the submission of the Biologics License Application (“BLA”) for omburtamab under the FDA’s Rolling Review process” ymabs.com ↗ “the Company completed the resubmission of its Biologics License Application (“BLA”) for 131I-omburtamab (“omburtamab”) to the FDA.” ymabs.com ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT04022213 | Jul 2019 → Jul 2026 overdue | desmoplastic small round cell tumor, peritoneal carcinoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03275402 | Dec 2018 → Jun 2023 | malignant tumor of meninges, metastatic malignant neoplasm in the brain, neuroblastoma | Y-mAbs Therapeutics | Terminated | No outcome recorded Stop: Business |
| Phase not stated1 trial | ||||||
| — | NCT05064306 | — | central nervous system neoplasm | Memorial Sloan Kettering Cancer Center | No longer available | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2022-12-01 | Y-mAbs Therapeutics | Regulatory Y-mAbs Announces Complete Response Letter for Omburtamab Biologics License Application ymabs.com ↗
The letter indicates that the FDA completed the review of the application and determined that it is unable to approve the BLA in its current form. |
| 2022-10-28 | Y-mAbs Therapeutics | Regulatory Y-mAbs Announces Outcome of FDA Advisory Committee Meeting on Omburtamab ymabs.com ↗
The committee voted 16 to 0 that the Company had not provided sufficient evidence to conclude that omburtamab improves overall survival. |
| 2022-10-03 | Y-mAbs Therapeutics | Results Y-mAbs Announces Pivotal Data for Omburtamab ymabs.com ↗
In an oral presentation, Dr. Kramer presented interim results for 32 patients enrolled in the Company’s ongoing pivotal 101 multicenter study of omburtamab radiolabeled with Iodine-131. |
| 2022-04-01 | Y-mAbs Therapeutics | Regulatory Y-mAbs Announces Submission of Omburtamab Biologics License Application to FDA ymabs.com ↗
today announced that on March 31, 2022, the Company completed the resubmission of its Biologics License Application (“BLA”) for 131I-omburtamab (“omburtamab”) to the FDA. |
| 2018-04-16 | Y-mAbs Therapeutics | Results Omburtamab as intraperitoneal radioimmunotherapy in desmoplastic small round cell tumor ymabs.com ↗
131I-omburtamab intraperitoneal RIT appears to have activity against micro-metastatic DSRCT. |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-12-01 | Y-mAbs Therapeutics | Y-mAbs Announces Complete Response Letter for Omburtamab Biologics License Application ymabs.com ↗ |
| 2022-10-28 | Y-mAbs Therapeutics | Y-mAbs Announces Outcome of FDA Advisory Committee Meeting on Omburtamab ymabs.com ↗ |
| 2022-10-03 | Y-mAbs Therapeutics | Y-mAbs Announces Pivotal Data for Omburtamab ymabs.com ↗ |
| 2022-04-01 | Y-mAbs Therapeutics | Y-mAbs Announces Submission of Omburtamab Biologics License Application to FDA ymabs.com ↗ |
| 2018-04-16 | Y-mAbs Therapeutics | Omburtamab as intraperitoneal radioimmunotherapy in desmoplastic small round cell tumor ymabs.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | 131I-omburtamab | “The purpose of this study is to test any good and bad effects of the study drug 131I-omburtamab.” NCT04022213 ↗ |
| Known as | I131-Omburtamab | “A Study of the Drug I131-Omburtamab in People With Desmoplastic Small Round Cell Tumors and Other Solid Tumors in the Peritoneum” NCT04022213 ↗ |
| Modality | Monoclonal antibody | “Murine IgG1 monoclonal antibody radiolabeled with iodine-131” NCT03275402 ↗ |