Tremelimumab (English Wikipedia)

"Tremelimumab". National Cancer Institute. Archived from the original on 10 August 2019. Retrieved 27 October 2022. This article incorporates text from this source, which is in the public domain.

doi.org

Ribas A (June 2012). "Tumor immunotherapy directed at PD-1". The New England Journal of Medicine. 366 (26): 2517–9. doi:10.1056/NEJMe1205943. PMID 22658126.
Tomillero A, Moral MA (October 2008). "Gateways to clinical trials". Methods Find Exp Clin Pharmacol. 30 (8): 643–72. doi:10.1358/mf.2008.30.5.1236622. PMID 19088949.
Poust J (December 2008). "Targeting metastatic melanoma". Am J Health Syst Pharm. 65 (24 Suppl 9): S9 – S15. doi:10.2146/ajhp080461. PMID 19052265.
Reuben JM, Lee BN, Li C, Gomez-Navarro J, Bozon VA, Parker CA, et al. (June 2006). "Biologic and immunomodulatory events after CTLA-4 blockade with ticilimumab in patients with advanced malignant melanoma". Cancer. 106 (11): 2437–44. doi:10.1002/cncr.21854. PMID 16615096.
Ribas A, Kefford R, Marshall MA, Punt CJ, Haanen JB, Marmol M, et al. (February 2013). "Phase III randomized clinical trial comparing tremelimumab with standard-of-care chemotherapy in patients with advanced melanoma". Journal of Clinical Oncology. 31 (5): 616–22. doi:10.1200/JCO.2012.44.6112. PMC 4878048. PMID 23295794.
Marshall MA, Ribas A, Huang B (May 2010). "Evaluation of baseline serum C-reactive protein (CRP) and benefit from tremelimumab compared to chemotherapy in first-line melanoma". Journal of Clinical Oncology. 28 (15S): 2609. doi:10.1200/jco.2010.28.15_suppl.2609.

europa.eu

ema.europa.eu

"Imjudo EPAR". European Medicines Agency (EMA). 9 December 2022. Archived from the original on 3 March 2023. Retrieved 2 March 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
"Imjudo: Pending EC decision". European Medicines Agency (EMA). 15 December 2022. Archived from the original on 16 December 2022. Retrieved 16 December 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

ec.europa.eu

"Imjudo Product information". Union Register of medicinal products. 23 February 2023. Archived from the original on 27 February 2023. Retrieved 2 March 2023.

fda.gov

accessdata.fda.gov

"Drug Approval Package: Imjudo". U.S. Food and Drug Administration (FDA). 4 November 2022. Archived from the original on 3 March 2023. Retrieved 2 March 2023.

fda.gov

"FDA approves tremelimumab in combination with durvalumab and platinum-". U.S. Food and Drug Administration (FDA). 10 November 2022. Archived from the original on 20 December 2022. Retrieved 20 December 2022.

fdanewsalert.com

Krassenstein B (29 February 2016). "Tremelimumab Fails Mesothelioma Drug Trial". FDA News Alert. Archived from the original on 6 March 2016. Retrieved 6 March 2016.

fiercebiotech.com

Adams B (27 July 2017). "AstraZeneca's immuno-oncology combo fails crucial Mystic trial in lung cancer". FierceBiotech. Archived from the original on 17 May 2022. Retrieved 23 August 2017.

handle.net

hdl.handle.net

World Health Organization (2008). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 59". WHO Drug Information. 22 (1). hdl:10665/74120.

hpfb-dgpsa.ca

dhpp.hpfb-dgpsa.ca

"Summary Basis of Decision (SBD) for Imjudo". Health Canada. 3 January 2024. Archived from the original on 17 January 2024. Retrieved 17 January 2024.
"Details for: Imjudo". Health Canada. 23 October 2023. Archived from the original on 17 January 2024. Retrieved 17 January 2024.

mesothelioma.com

Duff J (17 April 2015). "FDA Grants AstraZeneca's Tremelimumab Orphan Drug Status for Mesothelioma". Mesothelioma Cancer Alliance. Archived from the original on 31 July 2016.

nih.gov

pubmed.ncbi.nlm.nih.gov

Ribas A (June 2012). "Tumor immunotherapy directed at PD-1". The New England Journal of Medicine. 366 (26): 2517–9. doi:10.1056/NEJMe1205943. PMID 22658126.
Tomillero A, Moral MA (October 2008). "Gateways to clinical trials". Methods Find Exp Clin Pharmacol. 30 (8): 643–72. doi:10.1358/mf.2008.30.5.1236622. PMID 19088949.
Poust J (December 2008). "Targeting metastatic melanoma". Am J Health Syst Pharm. 65 (24 Suppl 9): S9 – S15. doi:10.2146/ajhp080461. PMID 19052265.
Reuben JM, Lee BN, Li C, Gomez-Navarro J, Bozon VA, Parker CA, et al. (June 2006). "Biologic and immunomodulatory events after CTLA-4 blockade with ticilimumab in patients with advanced malignant melanoma". Cancer. 106 (11): 2437–44. doi:10.1002/cncr.21854. PMID 16615096.
Ribas A, Kefford R, Marshall MA, Punt CJ, Haanen JB, Marmol M, et al. (February 2013). "Phase III randomized clinical trial comparing tremelimumab with standard-of-care chemotherapy in patients with advanced melanoma". Journal of Clinical Oncology. 31 (5): 616–22. doi:10.1200/JCO.2012.44.6112. PMC 4878048. PMID 23295794.

dailymed.nlm.nih.gov

"Imjudo- tremelimumab injection, solution". DailyMed. 10 November 2022. Archived from the original on 18 November 2022. Retrieved 18 November 2022.

ncbi.nlm.nih.gov

Ribas A, Kefford R, Marshall MA, Punt CJ, Haanen JB, Marmol M, et al. (February 2013). "Phase III randomized clinical trial comparing tremelimumab with standard-of-care chemotherapy in patients with advanced melanoma". Journal of Clinical Oncology. 31 (5): 616–22. doi:10.1200/JCO.2012.44.6112. PMC 4878048. PMID 23295794.

pfizer.com

"Pfizer Announces Discontinuation of Phase III Clinical Trial for Patients with Advanced Melanoma". Pfizer.com. 1 April 2008. Archived from the original on 8 December 2015. Retrieved 5 December 2015.

pharmatimes.com

McKee S (1 March 2016). "AZ' tremelimumab fails in mesothelioma trial". PharmaTimes. Archived from the original on 6 March 2016. Retrieved 6 March 2016.

tga.gov.au

"Imjudo". Therapeutic Goods Administration (TGA). 29 June 2023. Retrieved 10 September 2023.
"Imjudo (AstraZeneca Pty Ltd)". Therapeutic Goods Administration (TGA). 28 July 2023. Archived from the original on 11 September 2023. Retrieved 10 September 2023.
"AusPAR: Imjudo". www.tga.gov.au.

web.archive.org

"Imjudo (AstraZeneca Pty Ltd)". Therapeutic Goods Administration (TGA). 28 July 2023. Archived from the original on 11 September 2023. Retrieved 10 September 2023.
"Notice: Multiple additions to the Prescription Drug List (PDL) [2023-10-26]". Health Canada. 26 October 2023. Archived from the original on 3 January 2024. Retrieved 3 January 2024.
"Summary Basis of Decision (SBD) for Imjudo". Health Canada. 3 January 2024. Archived from the original on 17 January 2024. Retrieved 17 January 2024.
"Details for: Imjudo". Health Canada. 23 October 2023. Archived from the original on 17 January 2024. Retrieved 17 January 2024.
"Imjudo- tremelimumab injection, solution". DailyMed. 10 November 2022. Archived from the original on 18 November 2022. Retrieved 18 November 2022.
"Imjudo EPAR". European Medicines Agency (EMA). 9 December 2022. Archived from the original on 3 March 2023. Retrieved 2 March 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
"Drug Approval Package: Imjudo". U.S. Food and Drug Administration (FDA). 4 November 2022. Archived from the original on 3 March 2023. Retrieved 2 March 2023.
"Imjudo (tremelimumab) in combination with Imfinzi approved in the US for patients with unresectable liver cancer". AstraZeneca (Press release). 26 October 2022. Archived from the original on 24 October 2022. Retrieved 26 October 2022.
"FDA approves tremelimumab in combination with durvalumab and platinum-". U.S. Food and Drug Administration (FDA). 10 November 2022. Archived from the original on 20 December 2022. Retrieved 20 December 2022.
"Tremelimumab". National Cancer Institute. Archived from the original on 10 August 2019. Retrieved 27 October 2022. This article incorporates text from this source, which is in the public domain.
"Pfizer Announces Discontinuation of Phase III Clinical Trial for Patients with Advanced Melanoma". Pfizer.com. 1 April 2008. Archived from the original on 8 December 2015. Retrieved 5 December 2015.
Duff J (17 April 2015). "FDA Grants AstraZeneca's Tremelimumab Orphan Drug Status for Mesothelioma". Mesothelioma Cancer Alliance. Archived from the original on 31 July 2016.
Krassenstein B (29 February 2016). "Tremelimumab Fails Mesothelioma Drug Trial". FDA News Alert. Archived from the original on 6 March 2016. Retrieved 6 March 2016.
McKee S (1 March 2016). "AZ' tremelimumab fails in mesothelioma trial". PharmaTimes. Archived from the original on 6 March 2016. Retrieved 6 March 2016.
Adams B (27 July 2017). "AstraZeneca's immuno-oncology combo fails crucial Mystic trial in lung cancer". FierceBiotech. Archived from the original on 17 May 2022. Retrieved 23 August 2017.
"AstraZeneca reports initial results from the ongoing MYSTIC trial in Stage IV lung cancer". AstraZeneca (Press release). 27 July 2017. Archived from the original on 28 August 2021. Retrieved 23 August 2017.
"Imjudo: Pending EC decision". European Medicines Agency (EMA). 15 December 2022. Archived from the original on 16 December 2022. Retrieved 16 December 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
"Imjudo Product information". Union Register of medicinal products. 23 February 2023. Archived from the original on 27 February 2023. Retrieved 2 March 2023.