Main Article Content
Abstract
There is a great need and opportunity for the development of medicines for rare orphan illnesses. In an increasing number of nations, it is projected that gastric cancer will become a rare disease. In recent years, the incidence of stomach cancer has continued to raise worldwide, accounting for 40% of all cases. The reality is that developing drugs for cancer is challenging, costly, and time-consuming, with only poor success rates. Due to the ineffectiveness of currently available treatments, their high cost, and the potential for therapy to lower quality of life, repurposing has become a crucial strategy in the development of anti-cancer medications. Repurposing that supports the alternate applications of existing medications is encouraged by regulatory bodies like the FDA. Trastuzumab is a repurposed orphan drug for the treatment of HER2 positive gastric cancer. Trastuzumab was added to standard chemotherapy in the ToGA study, which increased patient survival for those with HER2-positive advanced G/GEJ adenocarcinoma and moved these patients into a new era of HER2-targeted therapy. The importance of medication repurposing, as well as the regulatory procedure for repurposed drugs in the United States and India are summarized in this study
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References
- 1. “Stomach Cancer: Statistics. Stomach Cancer Statistics”, WCRFI, https://www.wcrf.org/cancer-trends/stomach-cancer-statistics/
- 2. Araújo D., Ribeiro E., Amorim I, Vale N., “Repurposed Drugs in Gastric Cancer”, Molecules, vol. 28, no. 1, pp. 1-42, 2022, DOI: https://doi.org/10.3390/molecules28010319.
- 3. “FDA Approves Herceptin for HER2-Positive Metastatic Stomach Cancer”, FiercePharma, https://www.fiercepharma.com/pharma/fda-approves-herceptin-for-her2-positive-metastatic-stomach-cancer (accessed October 21 2010).
- 4. Bartley A. N., Washington M. K., etal., “HER2 Testing and Clinical Decision Making in Gastroesophageal Adenocarcinoma: Guideline From the College of American Pathologists, American Society for Clinical Pathology, and the American Society of Clinical Oncology”, Journal of clinical oncology: official journal of the American Society of Clinical Oncology, vol.35, no.4, pp. 446–464, 2017. DOI: https://doi.org/10.1200/JCO.2016.69.4836.
- 5. Li W., Zhang X., Du Y., Zhang Y., Lu J., Hu W., et al., “HER2-targeted advanced metastatic gastric/gastroesophageal junction adenocarcinoma: treatment landscape and future perspectives”, Biomark Research, vol. 10, no. 1, 2022. https://doi.org/10.1186/s40364-022-00416-x.
- 6. Hsu JL., Hung MC., “The role of HER2, EGFR, and other receptor tyrosine kinases in breast cancer”, Cancer Metastasis Reviews, vol. 35, no. 4, pp. 575–88,2016. DOI: https://doi.org/10.1007/s10555-016-9649-6.
- 7. Cooley S., Access O., Burns LJ., Repka T., Miller JS., “Natural killer cell cytotoxicity of breast cancer target is enhanced by two distinct mechanisms of antibody-dependent”, Journal of Hematology, Stemcell, Biology and Transplantation vol. 27, no. 10, pp. 1533–1541, 1999. DOI: https://doi.org/10.1016/S0301-472X(99)00089-2.
- 8. “Trastuzumab”, National Cancer Institute, https://www.cancer.gov/publications/dictionaries/cancer-terms/def/trastuzumab
- 9. Dr.Hina Firdous, “Herclon 440Mg Injection”, Lybrate, https://www.lybrate.com/medicine/herclon-440mg-injection
- 10. Greenblatt K., Khaddour K., “Trastuzumab”, StatPearls Publishing [ internet] 2023, pp. 8–13, https://www.ncbi.nlm.nih.gov/books/NBK532246/
- 11. Maadi H., Soheilifar M. H., Choi W. S., Moshtaghian A., Wang, Z., “Trastuzumab mechanism of action20 years of research to unravel a dilemma”, Cancers, vol. 13, no. 14 , pp. 1-17, 2021. DOI: https://doi.org/10.3390/cancers13143540.
- 12. “Herceptin (trastuzumab)” centerwatch, https://cms.centerwatch.com/directories/1067-fda-approved-drugs/listing/3603-herceptin-trastuzumab.
- 13. Dhir N., Jain A., Mahendru D., Prakash A., Medhi B., “Drug Repurposing and Orphan Disease Therapeutics” Drug Repurposing – Hypothesis, Molecular Aspects and Therapeutic Applications, pp. 1–17, 2020. DOI: https://doi.org/10.5772/intechopen.91941
- 14. Muthyala R., “Orphan/rare drug discovery through drug repositioning”, Drug Discovery Today Therapeutic Strategies, vol. 8, no. (3–4), pp. 71–76, 2011. https://doi.org/10.1016/j.ddstr.2011.10.003.
- 15. Dey G., An Overview of Drug Repurposing: Review Article. Journal of Medical Science Clinical Research, vol. 7, no. 2, pp. 55– 56, 2019. DOI: https://doi.org/10.18535/jmscr/v7i2.12.
- 16. .Pushpakom S., “Chapter 1: Introduction and Historical Overview of Drug Repurposing Opportunities”, Drug Discovery Series, 2022, pp. 1–13, 2022. DOI: https://doi.org/10.1039/9781839163401-00001.
References
1. “Stomach Cancer: Statistics. Stomach Cancer Statistics”, WCRFI, https://www.wcrf.org/cancer-trends/stomach-cancer-statistics/
2. Araújo D., Ribeiro E., Amorim I, Vale N., “Repurposed Drugs in Gastric Cancer”, Molecules, vol. 28, no. 1, pp. 1-42, 2022, DOI: https://doi.org/10.3390/molecules28010319.
3. “FDA Approves Herceptin for HER2-Positive Metastatic Stomach Cancer”, FiercePharma, https://www.fiercepharma.com/pharma/fda-approves-herceptin-for-her2-positive-metastatic-stomach-cancer (accessed October 21 2010).
4. Bartley A. N., Washington M. K., etal., “HER2 Testing and Clinical Decision Making in Gastroesophageal Adenocarcinoma: Guideline From the College of American Pathologists, American Society for Clinical Pathology, and the American Society of Clinical Oncology”, Journal of clinical oncology: official journal of the American Society of Clinical Oncology, vol.35, no.4, pp. 446–464, 2017. DOI: https://doi.org/10.1200/JCO.2016.69.4836.
5. Li W., Zhang X., Du Y., Zhang Y., Lu J., Hu W., et al., “HER2-targeted advanced metastatic gastric/gastroesophageal junction adenocarcinoma: treatment landscape and future perspectives”, Biomark Research, vol. 10, no. 1, 2022. https://doi.org/10.1186/s40364-022-00416-x.
6. Hsu JL., Hung MC., “The role of HER2, EGFR, and other receptor tyrosine kinases in breast cancer”, Cancer Metastasis Reviews, vol. 35, no. 4, pp. 575–88,2016. DOI: https://doi.org/10.1007/s10555-016-9649-6.
7. Cooley S., Access O., Burns LJ., Repka T., Miller JS., “Natural killer cell cytotoxicity of breast cancer target is enhanced by two distinct mechanisms of antibody-dependent”, Journal of Hematology, Stemcell, Biology and Transplantation vol. 27, no. 10, pp. 1533–1541, 1999. DOI: https://doi.org/10.1016/S0301-472X(99)00089-2.
8. “Trastuzumab”, National Cancer Institute, https://www.cancer.gov/publications/dictionaries/cancer-terms/def/trastuzumab
9. Dr.Hina Firdous, “Herclon 440Mg Injection”, Lybrate, https://www.lybrate.com/medicine/herclon-440mg-injection
10. Greenblatt K., Khaddour K., “Trastuzumab”, StatPearls Publishing [ internet] 2023, pp. 8–13, https://www.ncbi.nlm.nih.gov/books/NBK532246/
11. Maadi H., Soheilifar M. H., Choi W. S., Moshtaghian A., Wang, Z., “Trastuzumab mechanism of action20 years of research to unravel a dilemma”, Cancers, vol. 13, no. 14 , pp. 1-17, 2021. DOI: https://doi.org/10.3390/cancers13143540.
12. “Herceptin (trastuzumab)” centerwatch, https://cms.centerwatch.com/directories/1067-fda-approved-drugs/listing/3603-herceptin-trastuzumab.
13. Dhir N., Jain A., Mahendru D., Prakash A., Medhi B., “Drug Repurposing and Orphan Disease Therapeutics” Drug Repurposing – Hypothesis, Molecular Aspects and Therapeutic Applications, pp. 1–17, 2020. DOI: https://doi.org/10.5772/intechopen.91941
14. Muthyala R., “Orphan/rare drug discovery through drug repositioning”, Drug Discovery Today Therapeutic Strategies, vol. 8, no. (3–4), pp. 71–76, 2011. https://doi.org/10.1016/j.ddstr.2011.10.003.
15. Dey G., An Overview of Drug Repurposing: Review Article. Journal of Medical Science Clinical Research, vol. 7, no. 2, pp. 55– 56, 2019. DOI: https://doi.org/10.18535/jmscr/v7i2.12.
16. .Pushpakom S., “Chapter 1: Introduction and Historical Overview of Drug Repurposing Opportunities”, Drug Discovery Series, 2022, pp. 1–13, 2022. DOI: https://doi.org/10.1039/9781839163401-00001.