Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 65 |
| INN | Naxitamab |
| Status | Approved |
| Drug code(s) | hu3F8 |
| Brand name | DANYELZA |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | GD2 |
| Indications of clinical studies | Neuroblastoma; osteosarcoma |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved US, China |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | August 15, 2011 |
| Start of Phase 2 | July 15, 2015 |
| Start of Phase 3 | January 10, 2018 |
| Date BLA/NDA submitted to FDA | March 31, 2020 |
| Year of first approval (global) | 2020 |
| Date of first US approval | November 25, 2020 |
| INN, US product name | Naxitamab, naxitamab-gqgk |
| US or EU approved indications | DANYELZA is indicated, in combination with granulocyte-macrophage colony-stimulating factor (“GM-CSF”), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. |
| Company | Y-mabs Therapeutics |
| Licensee/Partner | None |
| Comments about company or candidate | Nov 2020: FDA approved under accelerated approval regulation based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory trial. The product has received Priority Review, Orphan Drug, Breakthrough Therapy, and Rare Pediatric Disease designations from the FDA. June 2020: Y-mAbs 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). The FDA set an action date of November 30, 2020, April 1, 2020: Y-mAbs Therapeutics 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. Nov. 29, 2019: Y-mAbs Therapeutics, Inc. 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. July 08, 2019: Y-mAbs Therapeutics, Inc. announced that it has completed a successful Type B Pre-Biologics License Application (“Pre-BLA”) meeting with the U.S. Food and Drug Administration (“FDA”) regarding a potential pathway for FDA approval of naxitamab for the treatment of patients with relapsed/refractory high-risk neuroblastoma. On 19 November 2018, orphan designation (EU/3/18/2094) was granted by the European Commission to Y-mAbs Therapeutics A/S, Denmark, for anti-GD2 monoclonal antibody 3F8 humanised (also known as naxitamab) for the treatment of neuroblastoma. Pivotal Phase 2 study NCT03363373 in children and adults diagnosed with high risk neuroblastoma and refractory osteomedullary disease started in January 2018. Breakthrough Therapy Designation granted by FDA. July 5, 2017 – Y-mAbs Therapeutics, Inc. (YmAbs), an immunotherapy company discovering and developing innovative treatments for patients with cancer, 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. As of July 2017, clinical studies all sponsored by Memorial Sloan Kettering. Naxitamab was conceived and developed by MSK physician-scientist Nai-Kong Cheung, who heads MSK’s Neuroblastoma Program. Y-mAbs submitted IND 132793 on 05 September 2017 after acquiring the rights to naxitamab from Memorial Sloan Kettering Cancer Center (MSK). MSK had studied naxitamab under IND(b) (4)112594 since 2012 and under IND [redacted]. (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761171Orig1s000MultidisciplineR.pdf) |
| Full address of company | 230 Park Avenue, Suite 3350 New York, NY 10169 USA North America United States of America https://ymabs.com/contact-us/ |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |