Dostarlimab

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Dostarlimab
Monoclonal antibody
TypeWhole antibody
SourceHumanized
TargetPDCD1
Clinical data
Trade namesJemperli
Other namesTSR-042, WBP-285, dostarlimab-gxly
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 a medication for the treatment of endometrial cancer.[4][5][7][8]

Dostarlimab is a programmed death receptor-1 (PD-1)–blocking monoclonal antibody.[4][5][6]

Dostarlimab was approved for medical use in the United States (US) and the European Union (EU) in April 2021.[4][5][9][6][10][11][12]

The most common side effects reported in the US include fatigue/asthenia, nausea, diarrhea, anemia, and constipation.[4][5] Additional common side effects reported in the EU include vomiting, joint pain, itching, rash, fever, and hypothyroidism (low levels of thyroid hormones).[6]

Medical uses

Dostarlimab is indicated for the treatment of adults with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen.[4][5][6]

On 17 August 2021, the US Food and Drug Administration (FDA) granted accelerated approval to dostarlimab for adults with mismatch repair deficient (dMMR) recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options.[13][14]

Side effects

Serious adverse reactions in >2% of patients included sepsis, acute kidney injury, urinary tract infection, abdominal pain, and pyrexia.[4][5]

Immune-mediated adverse reactions can occur including pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis.[4][5]

History

Dostarlimab is a PD-1 inhibitor. As of 2020, it is undergoing Phase I/II and Phase III clinical trials.[15][16][17] In 2020, the manufacturer, Tesaro, announced preliminary successful results from the Phase I/II GARNET study.[15][18][19]

In 2020, the GARNET study announced that dostarlimab was demonstrating potential to treat a subset of women with recurrent or advanced endometrial cancer.[20]

In April 2021, dostarlimab was approved for the treatment of recurrent or advanced endometrial cancer with deficient mismatch repair (dMMR), which are genetic abnormalities that disrupt DNA repair.[21]

On 22 April 2021, the Food and Drug Administration granted accelerated approval to dostarlimab-gxly (Jemperli, GlaxoSmithKline).[4] Efficacy was evaluated based on cohort (A1) in GARNET Trial (NCT02715284), a multicenter, multicohort, open-label trial in participants with advanced solid tumors.[4]

Society and culture

Dostarlimab is the international nonproprietary name (INN).[22]

Legal status

On 25 February 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a conditional marketing authorization for the medicinal product Jemperli, intended for the treatment of certain types of recurrent or advanced endometrial cancer.[23] The applicant for this medicinal product is GlaxoSmithKline (Ireland) Limited.[23] Dostarlimab was approved for medical use in the European Union in April 2021.[6]

References

  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. ^ "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.
  3. ^ "Summary Basis of Decision (SBD) for Jemperli". Health Canada. 23 October 2014. Archived from the original on 29 May 2022. Retrieved 29 May 2022.
  4. ^ a b c d e f g h i j "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.
  5. ^ a b c d e f g h "Jemperli- dostarlimab injection". DailyMed. Archived from the original on 1 March 2022. Retrieved 28 April 2021.
  6. ^ a b c d e f "Jemperli EPAR". European Medicines Agency (EMA). 24 February 2021. Archived from the original on 14 May 2022. Retrieved 16 July 2021.
  7. ^ Statement On A Nonproprietary Name Adopted By The USAN Council - Dostarlimab Archived 24 September 2018 at the Wayback Machine, American Medical Association.
  8. ^ Kasherman L, Ahrari S, Lheureux S (March 2021). "Dostarlimab in the treatment of recurrent or primary advanced endometrial cancer". Future Oncology. London, England. 17 (8): 877–892. doi:10.2217/fon-2020-0655. PMID 33251877.
  9. ^ "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.
  10. ^ "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.
  11. ^ "FDA Approves Jemperli (dostarlimab-gxly) for dMMR Endometrial Cancer" (Press release). AnaptysBio, Inc. 22 April 2021. Archived from the original on 19 August 2021. Retrieved 18 August 2021.
  12. ^ Galienne M, Rodrigues M (2021). "[New drug approval: Dostarlimab – second line in advanced MSI endometrial cancer]". Bulletin Du Cancer (in French). 108 (7–8): 675–676. doi:10.1016/j.bulcan.2021.04.006. PMID 33994164.
  13. ^ "FDA grants accelerated approval to dostarlimab-gxly for dMMR advanced solid tumors". U.S. Food and Drug Administration (FDA). 18 August 2021. Archived from the original on 18 August 2021. Retrieved 18 August 2021. Public Domain This article incorporates text from this source, which is in the public domain.
  14. ^ "GSK receives FDA accelerated approval for Jemperli (dostarlimab-gxly) for adult patients with mismatch repair-deficient (dMMR) recurrent or advanced solid tumors". GlaxoSmithKline (Press release). 17 August 2021. Archived from the original on 10 June 2022. Retrieved 18 August 2021.
  15. ^ a b Clinical trial number NCT02715284 for "A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an Anti-PD-1 Monoclonal Antibody, in Patients With Advanced Solid Tumors (GARNET)" at ClinicalTrials.gov
  16. ^ Clinical trial number NCT03981796 for "A Study of Dostarlimab (TSR-042) Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Patients With Recurrent or Primary Advanced Endometrial Cancer (RUBY)" at ClinicalTrials.gov
  17. ^ Clinical trial number NCT03602859 for "A Phase 3 Comparison of Platinum-Based Therapy With TSR-042 and Niraparib Versus Standard of Care Platinum-Based Therapy as First-Line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer (FIRST)" at ClinicalTrials.gov
  18. ^ "Data from GARNET study indicates robust activity of dostarlimab in patients with advanced or recurrent endometrial cancer". GSK (Press release). Archived from the original on 27 December 2019. Retrieved 1 January 2020.
  19. ^ Scalea B (28 May 2019). "Dostarlimab Effective in Endometrial Cancer Regardless of MSI Status". Targeted Oncology. Archived from the original on 27 December 2019. Retrieved 1 January 2020.
  20. ^ "GSK Presents New Data from the GARNET Study Demonstrating Potential of Dostarlimab to Treat a Subset of Women with Recurrent or Advanced Endometrial Cancer". Drugs.com. Archived from the original on 26 March 2022. Retrieved 29 April 2020.
  21. ^ "FDA Approves New Immunotherapy for Endometrial Cancer". Medscape. Archived from the original on 22 April 2021. Retrieved 23 April 2021.
  22. ^ World Health Organization (2019). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 81". WHO Drug Information. 33 (1). hdl:10665/330896.
  23. ^ a b "Jemperli: Pending EC decision". European Medicines Agency (EMA) (Press release). 25 February 2021. Archived from the original on 23 April 2021. Retrieved 22 April 2021.

External links

  • "Dostarlimab". Drug Information Portal. U.S. National Library of Medicine.
  • Clinical trial number NCT02715284 for "Study of TSR-042, an Anti-programmed Cell Death-1 Receptor (PD-1) Monoclonal Antibody, in Participants With Advanced Solid Tumors (GARNET)" at ClinicalTrials.gov