Drugs / Naxitamab
Naxitamab
also known as
hu3F8 · humanized 3F8 · DANYELZA · Humanized 3F8 Monoclonal Antibody · Monoclonal antibody hu3f8 · Naxitamab gqgk
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed neuroblastoma 5 milestones | |||||
| Filed | Other | 达佑泽 | neuroblastoma | 2023-02-08 | “宣布已向中国香港特别行政区卫生署递交达佑泽 ® （通用名：那西妥单抗注射液，Naxitamab Injection) 的新药上市申请，用于治疗复发性或难治性高危神经母细胞瘤患者。” sciclone.com ↗ “2021年9月，那西妥单抗的BLA被NMPA纳入优先审评；赛生药业在中国澳门递交那西妥单抗的BLA” sciclone.com ↗ “2021年9月，赛生药业在中国澳门递交达佑泽 ® 的上市申请。” sciclone.com ↗ |
| Filed | Other | DANYELZA | neuroblastoma | 2022-09-26 | “On September 26, Y-mAbs announced a regulatory filing for DANYELZA for the treatment of neuroblastoma in Brazil by Adium Pharma” ymabs.com ↗ |
| Filed | China (NMPA) | DANYELZA | neuroblastoma | 2021-07-06 | “今日宣布向中国国家药品监督管理局（NMPA）正式递交DANYELZA ® （那昔妥单抗）的上市许可申请（BLA）。” sciclone.com ↗ “2021年7月，赛生药业向中国国家药品监督管理局（NMPA）递交那西妥单抗的上市许可申请（BLA）并获受理” sciclone.com ↗ |
| Filed | US (FDA) | — | neuroblastoma | 2020-03-31 | “completed the submission of its Biologics License Application (“BLA”) under the FDA’s Rolling Review process for naxitamab after market close on March 31, 2020” ymabs.com ↗ “completed the submission of its rolling BLA submission to the FDA for naxitamab on March 31, 2020” ymabs.com ↗ “as the Company completed its BLA submission for naxitamab” ymabs.com ↗ |
| Filed | US (FDA) | — | neuroblastoma | 2019-11-29 | “it has submitted to the U.S. Food and Drug Administration (“FDA”) the first portions of its Biologics License Application (“BLA”) for naxitamab” ymabs.com ↗ |
| Filed relapsed/refractory diffuse large B-cell lymphoma 2 milestones | |||||
| Filed | Other | DANYELZA | relapsed/refractory diffuse large B-cell lymphoma | 2022-09-26 | “has submitted a regulatory filing for DANYELZA® (naxitamab-gqgk) for the treatment of patients with relapsed/refractory high-risk neuroblastoma to the Brazilian Health Regulatory Agency” ymabs.com ↗ |
| Filed | China (NMPA) | DANYELZA | relapsed/refractory diffuse large B-cell lymphoma | 2021-07-06 | “has submitted the Biologics License Application (“BLA”) for DANYELZA® (naxitamab-gqgk) for the treatment of patients with relapsed/refractory high-risk neuroblastoma to the...” ymabs.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | DANYELZA | — | 2020-11-25 | fda.gov ↗ |
Trials 23
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03189706 | Jun 2017 → Jun 2027 expected | neuroblastoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 14 trials | ||||||
| Phase 1 | NCT07027748 | Jun 2025 → Jul 2027 expected | neuroblastoma | Steven DuBois, MD | Recruiting | No outcome recorded |
| Phase 1 | NCT02650648 | Jan 2016 → Jul 2025 | neuroblastoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT01662804 | Aug 2012 → May 2021 | neuroblastoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT01419834 | Aug 2011 → Aug 2023 | neuroblastoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT07011654 | Sep 2025 → Jul 2028 expected | triple-negative breast carcinoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06026657 | Apr 2024 → Dec 2026 expected | Her2-receptor negative breast cancer | Margaret Gatti-Mays | Recruiting | No outcome recorded |
| Phase 1/2 | NCT01757626 | Dec 2012 → Dec 2026 expected | neuroblastoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 213 trials · 1 met primary | ||||||
| Phase 2 | NCT07537400 | Jun 2026 → Jun 2028 expected | neuroblastoma | Shaare Zedek Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06540963 | Dec 2024 → Dec 2030 expected | neuroblastoma | Giselle Sholler | Recruiting | No outcome recorded |
| Phase 2 | NCT06528496 | Jul 2024 → Jul 2029 expected | neuroblastoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05968768 | Oct 2023 → May 2027 expected | Ewing sarcoma | Anna Raciborska | Recruiting | No outcome recorded |
| Phase 2 | NCT06013618 | Jun 2023 → Dec 2026 expected | neuroblastoma | Sun Yat-sen University Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05489887 | Sep 2022 → Sep 2029 expected | neuroblastoma | Giselle Sholler | Recruiting | No outcome recorded |
| Phase 2 | NCT05754684 | Jan 2022 → Dec 2025 overdue | neuroblastoma | Hong Kong Children's Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04909515 | Dec 2021 → Jun 2026 | neuroblastoma | Y-mAbs Therapeutics | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT04560166 | Nov 2021 → Sep 2022 | neuroblastoma | Y-mAbs Therapeutics | Terminated | Met primary Stop: Business |
| Phase 2 | NCT06438614 | Aug 2020 → Jul 2023 | neuroblastoma, soft tissue neoplasm | Fundació Sant Joan de Déu | Completed | No outcome recorded |
| Phase 2 | NCT03363373 | Apr 2018 → Jun 2026 overdue | neuroblastoma | Y-mAbs Therapeutics | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03033303 | Jan 2017 → Sep 2025 | neuroblastoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT02502786 | Jul 2015 → Jul 2026 overdue | osteosarcoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT06047535 | Oct 2023 → Jun 2027 expected | neuroblastoma | SciClone Pharmaceuticals | Not yet recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04501757 | — | neuroblastoma | Memorial Sloan Kettering Cancer Center | No longer available | No outcome recorded |
News releases announcing trial results or a regulatory action · 47
| Date | Issuer | Release |
|---|---|---|
| 2025-03-03 | Orphan Australia | Results Y-mAbs Announces Publication of Phase 2 Interim Results in Nature Communications serb.com ↗
Overall, naxitamab demonstrated statistically significant efficacy with a manageable safety profile. |
| 2025-03-03 | Y-mAbs Therapeutics | Results Y-mAbs Announces Publication of Phase 2 Interim Results in Nature Communications ymabs.com ↗
Overall, naxitamab demonstrated statistically significant efficacy with a manageable safety profile. |
| 2024-09-06 | Orphan Australia | Results Y-mAbs Presents Neuroblastoma Research on Naxitamab and SADA PRIT Technology Platform at AACR Special Conference on Advances in Pediatric Cancer Research serb.com ↗
Patients with refractory/relapsed high-risk neuroblastoma and residual disease in the bone and/or bone marrow who were treated with naxitamab in combination with granulocyte-macrophage colony-stimulating factor (“GM-CSF”) achieved a disease control rate of 63%, with the results suggesting consistent disease control |
| 2024-09-06 | Y-mAbs Therapeutics | Results Y-mAbs Presents Neuroblastoma Research on Naxitamab and SADA PRIT Technology Platform at AACR Special Conference on Advances in Pediatric Cancer Research ymabs.com ↗
Patients with refractory/relapsed high-risk neuroblastoma and residual disease in the bone and/or bone marrow who were treated with naxitamab in combination with granulocyte-macrophage colony-stimulating factor (“GM-CSF”) achieved a disease control rate of 63%, with the results suggesting consistent disease control irrespective of baseline Curie score. |
| 2024-06-01 | Y-mAbs Therapeutics | Results Y-mAbs Announces New Interim Analysis of Phase 2 Data for Naxitamab at 2024 ASCO Annual Meeting ymabs.com ↗
The Trial 201 prespecified interim analysis achieved a 50% overall response rate (“ORR”) in 26 out of 52 patients. |
| 2023-10-16 | Orphan Australia | Results Y-mAbs Announces Publication in Cancers serb.com ↗
In this study, early administration of naxitamab-based chemo-immunotherapy was shown to significantly improve long-term outcomes, addressing an important unmet need in the current treatment paradigm for this critical patient group. |
| 2023-10-16 | Y-mAbs Therapeutics | Results Y-mAbs Announces Publication in Cancers ymabs.com ↗
In this study, early administration of naxitamab-based chemo-immunotherapy was shown to significantly improve long-term outcomes, addressing an important unmet need in the current treatment paradigm for this critical patient group. |
| 2023-05-26 | Y-mAbs Therapeutics | Results Y-mAbs Announces Presentation of Naxitamab Data at ASCO ymabs.com ↗
Overall, the most common naxitamab related serious adverse events were hypotension, pain, urticaria, and bronchospasm. |
| 2023-05-23 | Orphan Australia | Regulatory Y-mAbs’ DANYELZA® (naxitamab-gqgk) for the Treatment of High-Risk Neuroblastoma approved in Brazil serb.com ↗
Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (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 Brazilian Health Regulatory Agency, Agência Nacional de Vigilância Sanitária (“Anvisa”) has granted marketing authorization for DANYELZA (naxitamab-gqgk) 40mg/10mL injection. |
| 2023-05-23 | Y-mAbs Therapeutics | Regulatory Y-mAbs’ DANYELZA® (naxitamab-gqgk) for the Treatment of High-Risk Neuroblastoma approved in Brazil ymabs.com ↗ |
| 2023-04-18 | Y-mAbs Therapeutics | Results Y-mAbs Announces Presentation of Naxitamab data at AACR ymabs.com ↗ |
| 2023-02-08 | SciClone Pharmaceuticals | Regulatory 赛生药业在中国香港递交达佑泽®（那西妥单抗）的上市申请，用于治疗高危神经母细胞瘤 sciclone.com ↗
赛生药业控股有限公司（“赛生药业”或“公司”，连同其附属公司，统称“集团”，股份代号：6600.HK）宣布已向中国香港特别行政区卫生署递交达佑泽 ® （通用名：那西妥单抗注射液，Naxitamab Injection) 的新药上市申请，用于治疗复发性或难治性高危神经母细胞瘤患者。 |
| 2023-02-02 | Orphan Australia | Regulatory Y-mAbs and the European Medicines Agency Reach Agreement on the Pediatric Investigation Plan for Naxitamab serb.com ↗
the European Medicines Agency (“EMA”) has agreed to the Company’s proposed Pediatric Investigation Plan (“PIP”) for naxitamab. |
| 2023-02-02 | Y-mAbs Therapeutics | Regulatory Y-mAbs and the European Medicines Agency Reach Agreement on the Pediatric Investigation Plan for Naxitamab ymabs.com ↗
The decision follows a positive opinion from EMA’s Pediatric Committee (“PDCO”). |
| 2022-12-08 | SciClone Pharmaceuticals | Regulatory 赛生药业宣布达佑泽®（那西妥单抗）在中国获批 神经母细胞瘤患者迎来新的治疗选择 sciclone.com ↗
宣布达佑泽 ® （通用名：那西妥单抗注射液，Naxitamab Injection) 在中国获得国家药品监督管理局（NMPA）批准与粒细胞-巨噬细胞集落刺激因子（GM-CSF）联合给药，用于治疗伴有骨或骨髓病变，对既往治疗表现为部分缓解、轻微缓解或疾病稳定的复发性或难治性高危神经母细胞瘤的儿童（1岁及以上）或成人患者。 |
| 2022-12-08 | Orphan Australia | Regulatory Y-mAbs’ DANYELZA® (naxitamab-gqgk) for the Treatment of High-Risk Neuroblastoma Approved in China serb.com ↗ |
| 2022-12-08 | Y-mAbs Therapeutics | Regulatory Y-mAbs’ DANYELZA® (naxitamab-gqgk) for the Treatment of High-Risk Neuroblastoma Approved in China ymabs.com ↗
NEW YORK, Dec. 08, 2022 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (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 National Medical Products Administration (“NMPA”) in China has granted DANYELZA (naxitamab-gqgk) 40mg/10ml conditional approval. |
| 2022-09-26 | Y-mAbs Therapeutics | Regulatory Y-mAbs Announces Regulatory Filing for DANYELZA® (naxitamab-gqgk) in Brazil ymabs.com ↗
Y-mAbs Therapeutics, Inc. (“Y-mAbs”, 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 Adium Pharma S.A. (“Adium”) has submitted a regulatory filing for DANYELZA® (naxitamab-gqgk) for the treatment of patients with relapsed/refractory high-risk neuroblastoma to the Brazilian Health Regulatory Agency, Agência Nacional de Vigilância Sanitária (“Anvisa”). |
| 2022-08-30 | Orphan Australia | Regulatory Y-mAbs and Takeda Announces Marketing Authorization in Israel for DANYELZA® (naxitamab-gqgk) for Neuroblastoma serb.com ↗
The approval in Israel further demonstrates our commitment to expanding the reach of our commercial stage products internationally to patients with unmet medical needs. |
| 2022-08-30 | Y-mAbs Therapeutics | Regulatory Y-mAbs and Takeda Announces Marketing Authorization in Israel for DANYELZA® (naxitamab-gqgk) for Neuroblastoma ymabs.com ↗ |
| 2022-08-08 | Y-mAbs Therapeutics | Results Y-mAbs Announces Second Quarter Financial Results and Recent Corporate Developments ymabs.com ↗
We were also thrilled to announce that the Phase 2 naxitamab chemo-immunotherapy trial met primary endpoints achieving an impressive response rate further underscoring DANYELZA potential in high-risk neuroblastoma. |
| 2022-06-28 | SciClone Pharmaceuticals | Regulatory 赛生药业旗下那西妥单抗新适应症II期临床申请获批 sciclone.com ↗
由公司提交的“Naxitamab和粒细胞-巨噬细胞集落刺激因子联合伊立替康及替莫唑胺治疗原发难治性或首次复发的高危神经母细胞瘤”（临床试验编号：203，以下简称“203研究”）的临床试验申请获得批准。 |
| 2022-05-26 | Orphan Australia | Results Y-mAbs Announces Naxitamab Chemoimmunotherapy Investigational Trial for High-Risk Neuroblastoma Meets Primary Endpoint serb.com ↗ |
| 2022-05-26 | Y-mAbs Therapeutics | Results Y-mAbs Announces Naxitamab Chemoimmunotherapy Investigational Trial for High-Risk Neuroblastoma Meets Primary Endpoint ymabs.com ↗
The primary endpoint was reached in the MSK phase 2 trial: Objective Response Rate (“ORR”) according to the International Neuroblastoma Response Criteria (“INRC”) of 30.6 |
| 2022-04-20 | SciClone Pharmaceuticals | Regulatory 赛生药业提交那西妥单抗新适应症II期临床试验申请并获受理 sciclone.com ↗
公司提交的“Naxitamab和粒细胞-巨噬细胞集落刺激因子联合伊立替康及替莫唑胺治疗原发难治性或首次复发的高危神经母细胞瘤”（临床试验编号：203，以下简称“203研究”）的临床试验申请已获国家药品监督管理局（NMPA）药品审评中心（CDE）的正式受理（受理号：JXSL2200047国）。 |
| 2021-12-15 | Y-mAbs Therapeutics | Results UPDATE - Y-mAbs Announces Pipeline Update ymabs.com ↗ |
| 2021-09-14 | SciClone Pharmaceuticals | Regulatory 赛生药业宣布DANYELZA®（那西妥单抗）被国家药监局纳入优先审评 sciclone.com ↗
今日宣布，DANYELZA ® （那西妥单抗注射液）的上市许可申请（BLA）已被国家药品监督管理局（NMPA）药品审评中心（CDE）纳入优先审评，拟定适应症为治疗复发性或难治性高危神经母细胞瘤患者。 |
| 2021-09-13 | Y-mAbs Therapeutics | Regulatory Y-mAbs Announces Priority Review of BLA for DANYELZA® (naxitamab-gqgk) in China 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 its partner SciClone Pharmaceuticals (Holdings) Limited (“SciClone Pharmaceuticals”) has been granted priority review of the Biologics License Application (“BLA”) for DANYELZA® (naxitamab-gqgk) for the treatment of patients with relapsed/refractory high-risk neuroblastoma by the Center for Drug Evaluation (“CDE”) of China’s National Medical Products Administration (“NMPA”). |
| 2021-07-06 | SciClone Pharmaceuticals | Regulatory 赛生药业与Y-mAbs宣布递交DANYELZA®（那昔妥单抗）在中国的上市许可申请 sciclone.com ↗
今日宣布向中国国家药品监督管理局（NMPA）正式递交DANYELZA ® （那昔妥单抗）的上市许可申请（BLA）。 |
| 2021-07-06 | Y-mAbs Therapeutics | Regulatory Y-mAbs Announces NMPA Submission of BLA for DANYELZA® (naxitamab-gqgk) in China ymabs.com ↗
we are excited that within just seven months after FDA’s approval of DANYELZA®, we have been able to submit our BLA to the NMPA in China. |
| 2021-06-04 | Orphan Australia | Results Y-mAbs Announces Frontline Data for DANYELZA® (naxitamab-gqgk) in High-Risk Neuroblastoma serb.com ↗
The three-year event free survival (“EFS”) for patients in first CR was 74% and 19% for second or later CR. |
| 2021-06-04 | Y-mAbs Therapeutics | Results Y-mAbs Announces Frontline Data for DANYELZA® (naxitamab-gqgk) in High-Risk Neuroblastoma ymabs.com ↗
The three-year event free survival (“EFS”) for patients in first CR was 74% and 19% for second or later CR. |
| 2020-12-16 | Y-mAbs Therapeutics | Results Y-mAbs Announces Pipeline Update ymabs.com ↗
Patients in first CR showed an overall 74.3% event free survival (“EFS”) at 24 months and an overall survival (“OS”) of 91.6% at 24 months. |
| 2020-12-09 | Orphan Australia | Results Y-mAbs Announces Update on DANYELZA® (naxitamab-gqgk) at ESMO serb.com ↗
By independent review, the overall response rate (“ORR”) in Study 201 was 68% with 59% complete responses (“CR”). |
| 2020-12-09 | Y-mAbs Therapeutics | Results Y-mAbs Announces Update on DANYELZA® (naxitamab-gqgk) at ESMO ymabs.com ↗
By independent review, the overall response rate (“ORR”) in Study 201 was 68% with 59% complete responses (“CR”). |
| 2020-11-25 | Y-mAbs Therapeutics | Regulatory FDA Approves Y-mAbs’ DANYELZA® (naxitamab-gqgk) for the Treatment of Neuroblastoma ymabs.com ↗
today announced that the U.S. Food and Drug Administration (“FDA”) has approved DANYELZA (naxitamab-gqgk) 40mg/10ml. |
| 2020-10-16 | Y-mAbs Therapeutics | Results Y-mAbs Announces Update on Naxitamab and Omburtamab in Neuroblastoma ymabs.com ↗
The central independent evaluation showed an overall rate of response (“ORR”) of 68% and the rate of complete response (“CR”) was 59% for the 22 patients. |
| 2020-06-02 | Orphan Australia | Regulatory Y-mAbs Announces U.S. FDA Acceptance of Biologics License Application for Danyelza™ (naxitamab) for the Treatment of Neuroblastoma for Priority Review serb.com ↗ |
| 2020-06-02 | Y-mAbs Therapeutics | Regulatory Y-mAbs Announces U.S. FDA Acceptance of Biologics License Application for Danyelza™ (naxitamab) for the Treatment of Neuroblastoma for Priority Review ymabs.com ↗
today announced that the Biologics License Application (“BLA”) for Danyelza™ (naxitamab) for the treatment of patients with relapsed/refractory high-risk neuroblastoma has been accepted for priority review by the U.S. Food and Drug Administration (“FDA”). |
| 2020-04-01 | Y-mAbs Therapeutics | Regulatory Y-mAbs Announces Submission of Naxitamab Biologics License Application to U.S. 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 completed the submission of its Biologics License Application (“BLA”) under the FDA’s Rolling Review process for naxitamab after market close on March 31, 2020. |
| 2019-12-11 | Y-mAbs Therapeutics | Results Y-mAbs Announces Positive Naxitamab Frontline Data ymabs.com ↗
In terms of overall survival (“OS”), the naxitamab patients achieved an 86% OS at 24 months, compared to 84% OS for the competing anti-GD2 antibody. |
| 2019-11-29 | Y-mAbs Therapeutics | Regulatory Y-mAbs Initiates Rolling Submission of Biologics License Application to U.S. FDA for Naxitamab for Treatment of Neuroblastoma ymabs.com ↗
today announced that it has submitted to the U.S. Food and Drug Administration (“FDA”) the first portions of its Biologics License Application (“BLA”) for naxitamab for the treatment of patients with relapsed/refractory high-risk neuroblastoma under the FDA’s Rolling Review process. |
| 2019-10-25 | Y-mAbs Therapeutics | Results Y-mAbs Announces Naxitamab Update ymabs.com ↗
Essentially, this data relates to a subset of patients from Study 12-230 that demonstrate better than expected outcomes, including a 78% overall response rate. |
| 2019-07-08 | Y-mAbs Therapeutics | Regulatory Y-mAbs Announces Successful Pre-BLA Meeting with FDA for Naxitamab ymabs.com ↗
At the meeting, the Company reached alignment with the FDA on an Accelerated Approval Pathway for naxitamab along with a rolling BLA submission. |
| 2018-10-23 | Y-mAbs Therapeutics | Regulatory Naxitamab Receives Positive Opinion for Orphan Medicinal Product Designation Approval in the EU 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. |
| 2018-08-21 | Y-mAbs Therapeutics | Regulatory Y-mAbs Receives Breakthrough Therapy Designation for Naxitamab for the treatment of High Risk Neuroblastoma ymabs.com ↗
The FDA has granted Y-mAbs Breakthrough Therapy designation for naxitamab, in combination with GM-CSF, for the treatment of high risk neuroblastoma |
| 2017-07-05 | Y-mAbs Therapeutics | Regulatory YmAbs Granted Rare Pediatric Disease Designation for hu3F8 Antibody ymabs.com ↗
today announced that it has been granted a Rare Pediatric Disease Designation by the FDA for hu3F8, a monoclonal antibody for the treatment of Neuroblastoma. |
All press releases naming this drug 61 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 24 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Naxitamab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06047535 ↗ |
| Known as | DANYELZA | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06528496 ↗ |
| Known as | hu3F8 | “The anti-GD2 monoclonal antibody Naxitamab (also known as hu3F8) in combination with macrophage colony-stimulating factor (GM-CSF) is currently under pivotal phase 3...” NCT06438614 ↗10“Humanized Monoclonal Antibody 3F8 (Hu3F8) With Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in the Treatment of Recurrent Osteosarcoma” NCT02502786 ↗ “Humanized 3F8 Monoclonal Antibody (Hu3F8) When Combined With Interleukin-2 in Patients With High-Risk Neuroblastoma and GD2-positive Solid Tumors” NCT01662804 ↗ “Humanized 3F8 Monoclonal Antibody (Hu3F8) When Combined With Interleukin-2 in Patients With High-Risk Neuroblastoma and GD2-positive Solid Tumors” NCT01662804 ↗ “The purpose of this study is to find out if "humanized 3F8" (Hu3F8) is safe for treating neuroblastoma and other cancers.” NCT01419834 ↗ “Naxitamab, also known as hu3F8 is a humanised monoclonal antibody targeting GD2” NCT03363373 ↗ |
| Known as | humanized 3F8 | “The purpose of this study is to find out if an antibody called Humanized 3F8 (Hu3F8) combined with granulocyte- macrophage colony stimulating factor (GM-CSF) is safe for...” NCT01757626 ↗3“Humanized 3F8 Monoclonal Antibody (Hu3F8) When Combined With Interleukin-2 in Patients With High-Risk Neuroblastoma and GD2-positive Solid Tumors” NCT01662804 ↗ “The purpose of this study is to find out if "humanized 3F8" (Hu3F8) is safe for treating neuroblastoma and other cancers.” NCT01419834 ↗ “an antibody called Humanized 3F8 (Hu3F8)” NCT02502786 ↗ |
| Known as | Humanized 3F8 Monoclonal Antibody | “Humanized 3F8 Monoclonal Antibody (Hu3F8)” NCT01419834 ↗ |
| Known as | Monoclonal antibody hu3f8 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297984 ↗ |
| Known as | Naxitamab gqgk | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297984 ↗ |
| Modality | Monoclonal antibody | “Humanized 3F8 Monoclonal Antibody (Hu3F8)” NCT01419834 ↗ |
| Route | Intravenous | “one cycle has 2 days of intravenous hu3F8 treatment” NCT01419834 ↗ |