Dostarlimab

Dostarlimab
Monoclonal antibody
TypeWhole antibody
SourceHumanized
TargetPDCD1
Clinical data
Trade namesJemperli
Other namesTSR-042, WBP-285, dostarlimab-gxly
AHFS/Drugs.comMonograph
MedlinePlusa621030
License data
Pregnancy
category
Routes of
administration		Intravenous
Drug classAntineoplastic
ATC code
Legal status
Legal status
Identifiers
CAS Number
PubChem SID
DrugBank
UNII
KEGG
Chemical and physical data
FormulaC6420H9832N1690O2014S44
Molar mass144325.73 g·mol−1

Dostarlimab, sold under the brand name Jemperli, is a monoclonal antibody used as an anti-cancer medication for the treatment of endometrial cancer.[5][6][10] Dostarlimab is a programmed death receptor-1 (PD-1)–blocking monoclonal antibody.[5][6][8]

The most common side effects reported in the US include fatigue/asthenia, nausea, diarrhea, anemia, and constipation.[5][6] Additional side effects reported in the European Union include vomiting, joint pain, itching, rash, fever, and hypothyroidism (low levels of thyroid hormones).[8]

Dostarlimab was approved for the treatment of endometrial cancer in both the United States and the European Union in April 2021.[5][6][11][8][12]

Based on the Garnet trial, dostarlimab gained accelerated approval from the US Food and Drug Administration (FDA) in April 2021,[6] and full approval in February 2023.[7]

  1. ^ a b "Jemperli APMDS". Therapeutic Goods Administration (TGA). 2 March 2022. Archived from the original on 19 March 2022. Retrieved 5 March 2022.
  2. ^ "Updates to the Prescribing Medicines in Pregnancy database". Therapeutic Goods Administration (TGA). 21 December 2022. Archived from the original on 3 April 2022. Retrieved 2 January 2023.
  3. ^ "Notice: Multiple Additions to the Prescription Drug List (PDL) [2022-01-24]". Health Canada. 24 January 2022. Archived from the original on 29 May 2022. Retrieved 28 May 2022.
  4. ^ "Summary Basis of Decision (SBD) for Jemperli". Health Canada. 23 October 2014. Archived from the original on 29 May 2022. Retrieved 29 May 2022.
  5. ^ a b c d e "Jemperli- dostarlimab injection". DailyMed. Archived from the original on 1 March 2022. Retrieved 28 April 2021.
  6. ^ a b c d e f "FDA grants accelerated approval to dostarlimab-gxly for dMMR endometrial cancer". U.S. Food and Drug Administration (FDA) (Press release). 22 April 2021. Archived from the original on 22 April 2021. Retrieved 22 April 2021. Public Domain This article incorporates text from this source, which is in the public domain.
  7. ^ a b "FDA grants regular approval to dostarlimab-gxly for dMMR endometrial cancer". U.S. Food and Drug Administration (FDA). 9 February 2023. Archived from the original on 10 February 2023. Retrieved 10 February 2023. Public Domain This article incorporates text from this source, which is in the public domain.
  8. ^ a b c d "Jemperli EPAR". European Medicines Agency (EMA). 24 February 2021. Archived from the original on 14 May 2022. Retrieved 16 July 2021. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  9. ^ "Jemperli Product information". Union Register of medicinal products. Archived from the original on 5 March 2023. Retrieved 3 March 2023.
  10. ^ Kasherman L, Ahrari S, Lheureux S (March 2021). "Dostarlimab in the treatment of recurrent or primary advanced endometrial cancer". Future Oncology. 17 (8): 877–892. doi:10.2217/fon-2020-0655. PMID 33251877. S2CID 227234713.
  11. ^ "FDA grants accelerated approval for GSK's Jemperli (dostarlimab-gxly) for women with recurrent or advanced dMMR endometrial cancer" (Press release). GlaxoSmithKline. 22 April 2021. Archived from the original on 23 April 2021. Retrieved 22 April 2021 – via PR Newswire.
  12. ^ "European Commission Approves Jemperli (dostarlimab), the First Anti-PD-1 Therapy Approved for Recurrent or Advanced dMMR/MSI-H Endometrial Cancer in Europe" (Press release). AnaptysBio Inc. 23 April 2021. Archived from the original on 17 July 2021. Retrieved 13 July 2021 – via GlobeNewswire.