Naxitamab

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Naxitamab
Monoclonal antibody
TypeWhole antibody
TargetGD2
Names
Trade namesDanyelza
Other namesNaxitamab-gqgk
Clinical data
Main usesNeuroblastoma[1]
Side effectsInfusion-related reaction, pain, fast heart rate, vomiting, cough, nausea, diarrhea, high blood pressure, tiredness, erythema multiforme, peripheral neuropathy, hives, fever, headache, injection site reaction, swelling, anxiety, irritability[1]
Routes of
use
Intravenous
External links
AHFS/Drugs.comMonograph
US NLMNaxitamab
Legal
License data
Legal status
Chemical and physical data
FormulaC6414H9910N1718O1996S44
Molar mass144436.50 g·mol−1

Naxitamab, sold under the brand name Danyelza, is a medication used to treat neuroblastoma.[1] It is used in those who are at least a year old with disease in the bone that have not responded sufficiently to other treatment.[1] It is given by gradual injection into a vein.[1] It is used with a granulocyte-macrophage colony-stimulating factor (GM-CSF).[1]

Common side effects include infusion-related reaction, pain, fast heart rate, vomiting, cough, nausea, diarrhea, high blood pressure, tiredness, erythema multiforme, peripheral neuropathy, hives, fever, headache, injection site reaction, swelling, anxiety, and irritability.[1] Other side effects may include transverse myelitis and reversible posterior leukoencephalopathy syndrome (RPLS).[1] Use in pregnancy may harm the baby.[1] It is a monoclonal antibody that binds to GD2.[1]

Naxitamab was approved for medical use in the United States in 2020.[1] As of 2022 it is not approved in Europe or the United Kingdom.[2] In the United States 40 mg of medication costs about 23,000 USD as of 2022.[3]

Medical uses

Naxitamab is used in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) to treat people one year of age and older with high-risk neuroblastoma in bone or bone marrow whose tumor did not respond to or has come back after previous treatments and has shown a partial response, minor response, or stable disease to prior therapy.[4]

Dosage

It is given at a dose of 3 mg/kg/day, up to a maximum of 150 mg/day.[1] It is given on days 1, 3, and 5 of each treatment cycle with cycles repeated every 4 weeks until complete or partial response, followed by 5 additional cycles every 4 weeks.[1] Subsequent cycles may be repeated every 8 weeks.[1]

History

The application for naxitamab was approved based on two clinical trials (Trial 1/NCT03363373 and Trial 2/NCT01757626) of 97 participants with high-risk neuroblastoma in bone or bone marrow.[4] The trials were conducted at four centers in the United States and in Spain.[4] Both trials enrolled participants who were previously treated for high-risk neuroblastoma in the bone or bone marrow.[4] Some participants were not responding to the previous therapies anymore and some participants experienced the return of the cancer.[4] Participants with cancer that was actively growing after their last therapy were not included in the trial.[4] All participants received naxitamab in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) according to the trial schedule.[4]

The U.S. Food and Drug Administration (FDA) granted the application for naxitamab priority review, breakthrough therapy, and, orphan drug designations.[5] The FDA issued a priority review voucher for this rare pediatric disease product application[5] and was later granted a priority approval.[6]

Society and culture

Legal status

Naxitamab was approved for medical use in the United States in November 2020.[7][8]

References

  1. 1.00 1.01 1.02 1.03 1.04 1.05 1.06 1.07 1.08 1.09 1.10 1.11 1.12 1.13 1.14 "Danyelza- naxitamab injection". DailyMed. Archived from the original on 23 May 2021. Retrieved 22 May 2021.
  2. "Naxitamab". SPS - Specialist Pharmacy Service. 14 April 2019. Archived from the original on 30 January 2022. Retrieved 3 November 2022.
  3. "Danyelza Prices, Coupons, Copay & Patient Assistance". Drugs.com. Archived from the original on 19 May 2022. Retrieved 3 November 2022.
  4. 4.0 4.1 4.2 4.3 4.4 4.5 4.6 "Drugs Trials Snapshot: Danyelza". U.S. Food and Drug Administration (FDA). 25 November 2020. Archived from the original on 22 December 2020. Retrieved 25 December 2020. Public Domain This article incorporates text from this source, which is in the public domain.
  5. 5.0 5.1 "FDA grants accelerated approval to naxitamab for high-risk neuroblastoma in bone or bone marrow". U.S. Food and Drug Administration (FDA) (Press release). 25 November 2020. Archived from the original on 25 November 2020. Retrieved 25 November 2020. Public Domain This article incorporates text from this source, which is in the public domain.
  6. Markham A (February 2021). "Naxitamab: First Approval". Drugs. 81 (2): 291–296. doi:10.1007/s40265-021-01467-4. PMID 33616889. S2CID 231981814.
  7. "Naxitamab: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Archived from the original on 18 January 2021. Retrieved 29 November 2020.
  8. "Drug Approval Package: Danyelza". U.S. Food and Drug Administration (FDA). 22 December 2020. Archived from the original on 26 December 2020. Retrieved 25 December 2020.

External links

External sites:
Identifiers:
  • Clinical trial number NCT03363373 for "Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow" at ClinicalTrials.gov
  • Clinical trial number NCT01757626 for "Combination Therapy of Antibody Hu3F8 With Granulocyte- Macrophage Colony Stimulating Factor (GM-CSF) in Patients With Relapsed/Refractory High-Risk Neuroblastoma" at ClinicalTrials.gov