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FDA Authorization Year for Keytruda: A Breakthrough in Cancer Treatment

The FDA authorization year for Keytruda, a revolutionary cancer treatment, is a significant milestone in the history of oncology. In this article, we will delve into the story of Keytruda, its development, and its impact on the treatment of various types of cancer.

What is Keytruda?

Keytruda, also known as pembrolizumab, is a monoclonal antibody that targets the PD-1 receptor on immune cells. It is designed to work by blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2, which can prevent the immune system from attacking cancer cells.

History of Keytruda

Keytruda was first approved by the FDA in September 2014 for the treatment of patients with metastatic melanoma who had progressed on or after prior platinum-based chemotherapy. This marked a significant breakthrough in the treatment of melanoma, as it was the first FDA-approved immunotherapy for the disease.

FDA Authorization Year for Keytruda

The FDA authorization year for Keytruda is 2014. This was a pivotal year for the treatment of cancer, as it marked the beginning of a new era in immunotherapy.

Keytruda's Impact on Cancer Treatment

Since its initial approval, Keytruda has been approved for the treatment of several other types of cancer, including:

* Non-small cell lung cancer (NSCLC): Keytruda was approved in 2015 for the treatment of patients with NSCLC who have progressed on or after platinum-based chemotherapy.
* Head and neck squamous cell carcinoma (HNSCC): Keytruda was approved in 2016 for the treatment of patients with HNSCC who have progressed on or after platinum-based chemotherapy.
* Classical Hodgkin lymphoma (cHL): Keytruda was approved in 2017 for the treatment of patients with cHL who have relapsed or progressed after autologous hematopoietic stem cell transplantation (AHCT) or three or more lines of systemic therapy.
* Urothelial carcinoma: Keytruda was approved in 2017 for the treatment of patients with urothelial carcinoma who have progressed on or after platinum-based chemotherapy.

Keytruda's Mechanism of Action

Keytruda works by blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2. This allows the immune system to recognize and attack cancer cells more effectively.

Keytruda's Side Effects

Like all cancer treatments, Keytruda can cause side effects. The most common side effects of Keytruda include:

* Fatigue
* Muscle or bone pain
* Nausea
* Diarrhea
* Rash

Keytruda's Future Directions

Keytruda is being studied in several clinical trials for the treatment of other types of cancer, including:

* Breast cancer: Keytruda is being studied in combination with chemotherapy for the treatment of patients with triple-negative breast cancer.
* Colorectal cancer: Keytruda is being studied in combination with chemotherapy for the treatment of patients with colorectal cancer.
* Gastric cancer: Keytruda is being studied in combination with chemotherapy for the treatment of patients with gastric cancer.

Conclusion

The FDA authorization year for Keytruda is 2014. Since its initial approval, Keytruda has been approved for the treatment of several types of cancer and has become a standard of care in the treatment of many patients with advanced cancer. Its mechanism of action, side effects, and future directions are all discussed in this article.

Key Takeaways

* Keytruda is a monoclonal antibody that targets the PD-1 receptor on immune cells.
* The FDA authorization year for Keytruda is 2014.
* Keytruda has been approved for the treatment of several types of cancer, including melanoma, NSCLC, HNSCC, cHL, and urothelial carcinoma.
* Keytruda works by blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
* Keytruda can cause side effects, including fatigue, muscle or bone pain, nausea, diarrhea, and rash.

FAQs

1. What is Keytruda?
Keytruda is a monoclonal antibody that targets the PD-1 receptor on immune cells.
2. What is the FDA authorization year for Keytruda?
The FDA authorization year for Keytruda is 2014.
3. What types of cancer has Keytruda been approved for?
Keytruda has been approved for the treatment of several types of cancer, including melanoma, NSCLC, HNSCC, cHL, and urothelial carcinoma.
4. How does Keytruda work?
Keytruda works by blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
5. What are the side effects of Keytruda?
The most common side effects of Keytruda include fatigue, muscle or bone pain, nausea, diarrhea, and rash.

Sources

1. "Pembrolizumab (Keytruda) FDA Approval History." DrugPatentWatch.com.
2. "Keytruda (pembrolizumab) Prescribing Information." Merck & Co., Inc.
3. "Pembrolizumab (Keytruda) for the Treatment of Metastatic Melanoma." National Cancer Institute.
4. "Pembrolizumab (Keytruda) for the Treatment of Non-Small Cell Lung Cancer." National Cancer Institute.
5. "Pembrolizumab (Keytruda) for the Treatment of Head and Neck Squamous Cell Carcinoma." National Cancer Institute.

Note: The sources cited are the original sources of the information provided in the article.