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The FDA Approval Year for Keytruda: A Breakthrough in Cancer Treatment

H1. Introduction

In recent years, the field of cancer treatment has witnessed significant advancements, and one of the most notable breakthroughs is the approval of Keytruda (pembrolizumab) by the US Food and Drug Administration (FDA). Keytruda is a monoclonal antibody that targets the PD-1 protein, which plays a crucial role in the immune system's ability to recognize and attack cancer cells. In this article, we will delve into the FDA approval year for Keytruda and explore its impact on cancer treatment.

H2. What is Keytruda?

Keytruda, developed by Merck & Co., Inc., is an immunotherapy medication that works by inhibiting the PD-1 protein on T-cells, allowing them to recognize and attack cancer cells more effectively. This mechanism of action is based on the understanding that cancer cells often evade the immune system by expressing proteins that inhibit T-cell activation.

H3. FDA Approval Year for Keytruda

Keytruda was first approved by the FDA on September 4, 2014, for the treatment of patients with metastatic melanoma who have progressed on prior therapy. This approval marked a significant milestone in the development of immunotherapy for cancer treatment.

H4. Expansion of Indications

Since its initial approval, Keytruda has received numerous expansions of its indications, including:

* H4.1. Non-Small Cell Lung Cancer (NSCLC): In 2015, the FDA approved Keytruda for the treatment of patients with NSCLC who have progressed on prior platinum-based chemotherapy.
* H4.2. Head and Neck Squamous Cell Carcinoma (HNSCC): In 2016, the FDA approved Keytruda for the treatment of patients with HNSCC who have progressed on prior platinum-based chemotherapy.
* H4.3. Classical Hodgkin Lymphoma (cHL): In 2017, the FDA approved Keytruda for the treatment of patients with cHL who have progressed on prior chemotherapy.
* H4.4. Renal Cell Carcinoma (RCC): In 2019, the FDA approved Keytruda for the treatment of patients with RCC who have received prior anti-angiogenic therapy.

H5. Mechanism of Action

Keytruda's mechanism of action involves the inhibition of the PD-1 protein on T-cells, allowing them to recognize and attack cancer cells more effectively. This is achieved through the binding of Keytruda to the PD-1 protein, which blocks its interaction with its ligands, PD-L1 and PD-L2.

H6. Clinical Trials

The efficacy of Keytruda has been demonstrated in numerous clinical trials, including:

* H6.1. KEYNOTE-006: A phase III trial that demonstrated improved overall survival in patients with metastatic melanoma who received Keytruda compared to ipilimumab.
* H6.2. KEYNOTE-024: A phase III trial that demonstrated improved overall survival in patients with NSCLC who received Keytruda compared to chemotherapy.

H7. Side Effects

Like all medications, Keytruda can cause side effects, including:

* H7.1. Fatigue
* H7.2. Nausea
* H7.3. Diarrhea

H8. Dosage and Administration

Keytruda is administered intravenously at a dose of 200 mg every 3 weeks.

H9. Conclusion

The FDA approval year for Keytruda was 2014, marking a significant milestone in the development of immunotherapy for cancer treatment. Since its initial approval, Keytruda has received numerous expansions of its indications and has demonstrated improved efficacy in clinical trials.

H10. Key Takeaways

* Keytruda is an immunotherapy medication that targets the PD-1 protein on T-cells.
* Keytruda was first approved by the FDA in 2014 for the treatment of patients with metastatic melanoma.
* Keytruda has received numerous expansions of its indications, including NSCLC, HNSCC, cHL, and RCC.
* Keytruda's mechanism of action involves the inhibition of the PD-1 protein on T-cells.

H11. FAQs

1. Q: What is Keytruda?
A: Keytruda is an immunotherapy medication that targets the PD-1 protein on T-cells.
2. Q: What is the FDA approval year for Keytruda?
A: The FDA approval year for Keytruda is 2014.
3. Q: What are the indications for Keytruda?
A: Keytruda is approved for the treatment of patients with metastatic melanoma, NSCLC, HNSCC, cHL, and RCC.
4. Q: What are the side effects of Keytruda?
A: Common side effects of Keytruda include fatigue, nausea, and diarrhea.
5. Q: How is Keytruda administered?
A: Keytruda is administered intravenously at a dose of 200 mg every 3 weeks.

H12. References

* [1] DrugPatentWatch.com. (2022). Pembrolizumab (Keytruda) Patent Expiration Date.
* [2] Merck & Co., Inc. (2022). Keytruda (pembrolizumab) Prescribing Information.
* [3] FDA. (2022). Pembrolizumab (Keytruda) Approval Letter.

H13. About the Author

The author is a medical writer with expertise in oncology and immunotherapy. They have written numerous articles on cancer treatment and have a deep understanding of the latest developments in the field.

H14. Conclusion

In conclusion, the FDA approval year for Keytruda was 2014, marking a significant milestone in the development of immunotherapy for cancer treatment. Since its initial approval, Keytruda has received numerous expansions of its indications and has demonstrated improved efficacy in clinical trials.

H15. Final Thoughts

The approval of Keytruda has opened up new avenues for cancer treatment, and its impact will be felt for years to come. As research continues to advance, we can expect to see even more effective treatments for cancer patients.

FAQs

1. Q: What is the patent expiration date for Keytruda?
A: The patent expiration date for Keytruda is 2038 (Source: DrugPatentWatch.com).
2. Q: What is the mechanism of action of Keytruda?
A: Keytruda works by inhibiting the PD-1 protein on T-cells, allowing them to recognize and attack cancer cells more effectively.
3. Q: What are the common side effects of Keytruda?
A: Common side effects of Keytruda include fatigue, nausea, and diarrhea.
4. Q: How is Keytruda administered?
A: Keytruda is administered intravenously at a dose of 200 mg every 3 weeks.
5. Q: What are the indications for Keytruda?
A: Keytruda is approved for the treatment of patients with metastatic melanoma, NSCLC, HNSCC, cHL, and RCC.

Cited Sources:

1. DrugPatentWatch.com. (2022). Pembrolizumab (Keytruda) Patent Expiration Date.
2. Merck & Co., Inc. (2022). Keytruda (pembrolizumab) Prescribing Information.
3. FDA. (2022). Pembrolizumab (Keytruda) Approval Letter.