Dinutuximab
| Monoclonal antibody | |
|---|---|
| Type | ? |
| Source | Chimeric (mouse/human) |
| Target | GD2 |
| Clinical data | |
| Trade names | Unituxin |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| IUPHAR/BPS | |
| ChemSpider |
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Dinutuximab (tradename Unituxin) is a monoclonal antibody that targets glycolipid GD2, expressed on neuroblastoma cells and on normal cells of neuroectodermal origin, including the central nervous system and peripheral nerves. It was approved for use, in combination with granulocyte-macrophage colony stimulating factor (GM-CSF), interleukin-2 (IL-2) and 13-cis-retinoic acid (RA), for high-risk neuroblastoma in pediatric patients; it received FDA approval in March 2015.[2][3] It was initially developed by a federal agency, the U.S. National Cancer Institute in partnership with the Children’s Oncology Group.[4] In 2010 United Therapeutics were under contract with NCI to "conduct late-stage clinical testing, and to manufacture and market the drug."[4]
Side effects
Dinutuximab can causing severe pain by irritating nerve cells.[2] This requires intravenous narcotics.[2] It can also cause nerve damage and life-threatening infusion reactions.[2]
History
In August 2015 United Therapeutics sold its pediatric-rare disease FDA priority review voucher that it had received for the development of Unituxin to AbbVie for $350 million.[5] According to Forbes journalist Tim Worstall, a "lucrative secondary market"[5] emerged by 2015 in the form of vouchers that "require the FDA to shorten its decision deadline to six months from the standard 10 months—potentially giving companies an extra four months’ worth of sales. The voucher doesn’t guarantee the FDA will approve the drug."[4]
References
- ^ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 Oct 2023.
- ^ a b c d http://www.centerwatch.com/drug-information/fda-approved-drugs/drug/100074/unituxin-dinutuximab
- ^ "FDA approves first therapy for high-risk neuroblastoma". 10 March 2015. Retrieved 24 March 2015.
- ^ a b c Loftus, Peter (1 November 2015). "Drug Makers Buy Pricey Vouchers to Speed Products to Market". Wall Street Journal. Retrieved 19 November 2015.
- ^ a b Worstall, Tim (20 October 2015). "The Economic Proof That The FDA's Drug Regulation Makes Us All Poorer". Forbes. Retrieved 19 November 2015.
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