Drugs / Omburtamab
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Refused (EMA) | EU (EMA) | — | cns neuroblastoma with FOXR2 activation | 2022-12-16 | “CHMP has adopted a negative opinion recommending a refusal of the marketing authorization for omburtamab for the treatment of CNS/leptomeningeal metastasis from neuroblastoma in Europe.” ymabs.com ↗ |
| Rejected (CRL) | US (FDA) | — | cns neuroblastoma with FOXR2 activation | 2022-12-01 | “FDA has issued a complete response letter (“CRL”) for the Biologics License Application (“BLA”) for the investigational medicine 131I-omburtamab (“omburtamab”)” ymabs.com ↗ |
| Filed | US (FDA) | — | cns neuroblastoma with FOXR2 activation | 2022-03-31 | “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.” ymabs.com ↗ “The omburtamab BLA was resubmitted on March 31, 2022 and is currently under review with the FDA.” ymabs.com ↗ “Completed resubmission to the FDA of omburtamab BLA” ymabs.com ↗ |
| Filed | EU (EMA) | — | cns neuroblastoma with FOXR2 activation | 2021-04-27 | “submitted its Marketing Authorization Application (“MAA”) to the European Medicines Agency for omburtamab for the treatment of pediatric patients with CNS/leptomeningeal...” ymabs.com ↗ |
| Rejected (CRL) | US (FDA) | — | cns neuroblastoma with FOXR2 activation | 2020-10-05 | “received a Refusal to File letter from the U.S. Food and Drug Administration (“FDA”) regarding the Biologics License Application (“BLA”) for omburtamab” ymabs.com ↗ |
| Filed | US (FDA) | — | cns neuroblastoma with FOXR2 activation | 2020-06-30 | “the Company has initiated the submission of its Biologics License Application (“BLA”) for omburtamab under the U.S. Food and Drug Administration’s (“FDA”) Rolling Review process.” ymabs.com ↗ “on August 5, 2020, the Company completed the submission of its Biologics License Application (“BLA”) under the FDA’s Rolling Review process for omburtamab.” ymabs.com ↗ “completion of our omburtamab BLA submission to the FDA” ymabs.com ↗ |
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT05063357 | Mar 2022 → Mar 2026 | diffuse intrinsic pontine glioma | Y-mAbs Therapeutics | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT01502917 | Dec 2011 → Jan 2022 | diffuse intrinsic pontine glioma | Y-mAbs Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT01099644 | Apr 2010 → Jun 2019 | peritoneum cancer | Y-mAbs Therapeutics | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT00089245 | Feb 2004 → Feb 2022 | central nervous system neoplasm, neuroblastoma, sarcoma | Y-mAbs Therapeutics | Terminated | No outcome recorded Stop: Business |
| Phase 21 trial | ||||||
| Phase 2 | NCT04743661 | Apr 2022 → Mar 2026 overdue | ependymoma, medulloblastoma | Pediatric Brain Tumor Consortium | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 26
| Date | Issuer | Release |
|---|---|---|
| 2022-12-16 | Y-mAbs Therapeutics | Regulatory The CHMP has Adopted a Negative Opinion for Omburtamab for the Treatment of CNS/LM Metastasis from Neuroblastoma in Europe ymabs.com ↗
today announced that the European Committee for Medicinal Products for Human use (“CHMP”) has adopted a negative opinion recommending a refusal of the marketing authorization for omburtamab for the treatment of CNS/leptomeningeal metastasis from neuroblastoma in Europe. |
| 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 ↗
The results showed a twelve-month overall survival (“OS”) of 73.5%, with a median follow-up of 25 months. |
| 2022-09-01 | Y-mAbs Therapeutics | Regulatory Y-mAbs Announces Scheduling of FDA Advisory Committee Meeting for Omburtamab ymabs.com ↗
a meeting of the Oncologic Drugs Advisory Committee (“ODAC”) of the U.S. Food and Drug Administration (“FDA”) has been scheduled for October 28, 2022 |
| 2022-05-31 | Y-mAbs Therapeutics | Regulatory Y-mAbs Announces FDA Acceptance of Biologics License Application for OMBLASTYS® (omburtamab) for the Treatment of Neuroblastoma for Priority Review ymabs.com ↗ |
| 2022-04-01 | Y-mAbs Therapeutics | Regulatory Y-mAbs Announces Submission of Omburtamab Biologics License Application to FDA ymabs.com ↗
the Company completed the resubmission of its Biologics License Application (“BLA”) for 131I-omburtamab (“omburtamab”) to the FDA. |
| 2021-10-07 | Y-mAbs Therapeutics | Regulatory Y-mAbs’ 177Lu-omburtamab-DTPA for the Treatment of Patients with Medulloblastoma Granted Rare Pediatric Disease Designation by FDA ymabs.com ↗
Y-mAbs Therapeutics, Inc. (“Y-mAbs” or the “Company”) (NASDAQ: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Rare Pediatric Disease Designation (“RPDD”) for the Company’s lutetium labelled omburtamab antibody program for the treatment of medulloblastoma. |
| 2021-06-25 | Y-mAbs Therapeutics | Regulatory Y-mAbs’ 177Lu-omburtamab-DTPA for the Treatment of Patients with Medulloblastoma Receives Positive Opinion on Orphan Medicinal Product Designation by EMA ymabs.com ↗
The positive opinion from the EMA's COMP has been sent to the European Commission (“EC”), which is expected to grant the orphan drug designation within 30 days. |
| 2021-06-04 | Y-mAbs Therapeutics | Results Y-mAbs Announces Update on Omburtamab for DIPG ymabs.com ↗
The median overall survival of all 46 patients in the study increased by three to four months as compared to the historical control group. |
| 2021-04-27 | Y-mAbs Therapeutics | Regulatory Y-mAbs Submits Omburtamab Marketing Authorization Application to the European Medicines Agency ymabs.com ↗
today announced that the Company has submitted its Marketing Authorization Application (“MAA”) to the European Medicines Agency for omburtamab for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma. |
| 2021-04-20 | Y-mAbs Therapeutics | Regulatory Y-mAbs Provides Regulatory Update on Omburtamab ymabs.com ↗
Y-mAbs recently concluded a Type B meeting with the U.S. Food and Drug Administration (“FDA”) regarding omburtamab and received requests from the FDA for additional data concerning the granularity of data from our identified historical control groups. |
| 2020-12-16 | Y-mAbs Therapeutics | Results Y-mAbs Announces Pipeline Update ymabs.com ↗
The tumor response data for omburtamab paves the way for the resubmission of the BLA in early 2021. |
| 2020-11-19 | Y-mAbs Therapeutics | Results Y-mAbs Announces Update on Omburtamab in DIPG ymabs.com ↗
The study showed the possibility of repeated convection enhanced delivery (“CED”) infusions into the pediatric brainstem. |
| 2020-10-26 | Y-mAbs Therapeutics | Regulatory Y-mAbs Announces FDA Clearance of IND for Lutetium-177 Labeled Omburtamab Antibody for Adult Indications ymabs.com ↗
Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer announced today that the U.S. Food and Drug Administration (“FDA”) has cleared the Company’s Investigational New Drug (“IND”) application for 177Lu-omburtamab-DTPA for the treatment of B7-H3 positive Central Nervous System (“CNS”) and Leptomeningeal Metastasis (“LM”) from tumors in adult patients. |
| 2020-10-14 | Y-mAbs Therapeutics | Regulatory Y-mAbs Announces FDA Clearance of IND for its Lutetium-177 Labeled Omburtamab Antibody ymabs.com ↗
the U.S. Food and Drug Administration (“FDA”) has cleared the Company’s Investigational New Drug (“IND”) application for 177Lu-omburtamab-DTPA |
| 2020-10-05 | Y-mAbs Therapeutics | Regulatory Y-mAbs Provides Regulatory Update on Omburtamab for the Treatment of Patients with Neuroblastoma ymabs.com ↗
Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB), a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that Y-mAbs has received a Refusal to File letter from the U.S. Food and Drug Administration (“FDA”) regarding the Biologics License Application (“BLA”) for omburtamab for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma, which was submitted in August 2020. |
| 2020-08-06 | Y-mAbs Therapeutics | Regulatory Y-mAbs Announces Second Quarter 2020 Financial Results and Recent Corporate Developments ymabs.com ↗
Subsequent to the end of the second quarter, on August 6, 2020, Y-mAbs announced the completion of the submission of its omburtamab Biologics License Application to FDA for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma |
| 2020-08-06 | Y-mAbs Therapeutics | Regulatory Y-mAbs Announces Completion of Submission of Omburtamab Biologics License Application to FDA ymabs.com ↗ |
| 2020-06-30 | Y-mAbs Therapeutics | Regulatory Y-mAbs Announces Initiation of Submission of Omburtamab Rolling Biologics License Application to the FDA ymabs.com ↗
Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the Company has initiated the submission of its Biologics License Application (“BLA”) for omburtamab under the U.S. Food and Drug Administration’s (“FDA”) Rolling Review process. |
| 2020-02-26 | Y-mAbs Therapeutics | Regulatory Y-mAbs Announces Positive Pre-BLA Meeting with FDA for Omburtamab ymabs.com ↗
At the pre-BLA meeting, the Company reached alignment with the FDA on an Accelerated Approval Pathway for omburtamab along with a rolling BLA submission. |
| 2019-12-05 | Y-mAbs Therapeutics | Regulatory Y-mAbs and the European Medicines Agency Pediatric Committee Reach Agreement on the Pediatric Investigation Plan for Omburtamab ymabs.com ↗
Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB), a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the European Medicines Agency (“EMA”) has agreed to the Company’s proposed Pediatric Investigation Plan (“PIP”) for omburtamab. |
| 2019-11-15 | Y-mAbs Therapeutics | Results Y-mAbs Announces Update on Omburtamab in DSRCT ymabs.com ↗
The study showed a median OS of 41 months for the DSRCT patients who did not receive omburtamab IP-RIT and 59 months for those receiving omburtamab IP-RIT. |
| 2019-10-28 | Y-mAbs Therapeutics | Results Y-mAbs Announces Positive Omburtamab Clinical Data ymabs.com ↗
This compared well to a median survival of 47.1 months at the prior data readout based on the first 93 patients in the study. |
| 2018-04-16 | Y-mAbs Therapeutics | Results Omburtamab as intraperitoneal radioimmunotherapy in desmoplastic small round cell tumor ymabs.com ↗
Y-mAbs Therapeutics, Inc. (YmAbs), an immunotherapy company discovering and developing innovative treatments for patients with cancer, today announced Phase I clinical trial data for omburtamab in Desmoplastic Small Round Cell Tumor (DSRCT), which is a rare sarcoma of adolescents and young adults. |
| 2017-12-11 | Y-mAbs Therapeutics | Regulatory USAN Council and INN Expert Committee suggests to rename burtomab to omburtamab ymabs.com ↗
Y-mAbs Therapeutics, Inc. (YmAbs), an immunotherapy company discovering and developing innovative treatments for patients with cancer, today announced that the USAN Council and INN Expert Committee has suggested to change the generic nonproprietary drug name of burtomab to omburtamab. |
All press releases naming this drug 34 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Omburtamab | “In this phase I study, we evaluated the safety, pharmacokinetics, and biodistribution of intraperitoneal (IP) radioimmunotherapy (RIT) with the anti-B7H3 murine monoclonal...” PMID 33119478 ↗ Oct 20204“Patients will be injected, intrathecally, with 2 mCi 131I-Omburtamab during week 1 of a 5 week cycle.” NCT00089245 ↗ |
| Known as | 124I-Omburtamab | “The purpose of this study is to test the safety of a new method to treat Diffuse Intrinsic Pontine Glioma (DIPG). The researchers will use "convection-enhanced delivery" (CED)...” NCT01502917 ↗ |
| Known as | 131IOmburtamab | “In this phase I study, we evaluated the safety, pharmacokinetics, and biodistribution of intraperitoneal (IP) radioimmunotherapy (RIT) with the anti-B7H3 murine monoclonal...” PMID 33119478 ↗ Oct 20202“The dose used in this study is 50 mCi 131IOmburtamab, (averaging 5 mCi/mg Omburtamab at 50 mCi dose) which will be administered to each patient during week 2 of a 5 week cycle.” NCT00089245 ↗ “intraOmmaya 131I-omburtamab (8H9), an antiB7-H3 antibody” PMID 33047248 ↗ Oct 2020 |
| Known as | 8H9 | “intraOmmaya 131I-omburtamab (8H9), an antiB7-H3 antibody” PMID 33047248 ↗ Oct 2020 |
| Action | Deplete | “124I-omburtamab sticks to parts of tumor cells and can cause the tumor cells to die from radiation.” NCT01502917 ↗ |
| Modality | Monoclonal antibody | “the anti-B7H3 murine monoclonal antibody omburtamab” PMID 36371226 ↗ Nov 2022 |
| Route | Intrathecal | “Patients will be injected, intrathecally” NCT00089245 ↗ |
| Target | CD276 | “Omburtamab is a murine IgG1 monoclonal antibody (mAb) against B7-H3 (CD276)” NCT04743661 ↗ |