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Unlocking the Power of Immunotherapy: The FDA Approval Date of Keytruda in Cancer Care

Introduction

The landscape of cancer treatment has undergone a significant transformation in recent years, with the emergence of immunotherapy as a game-changing approach. One of the pioneering drugs in this field is Keytruda (pembrolizumab), a monoclonal antibody that has revolutionized the treatment of various types of cancer. In this article, we will delve into the FDA approval date of Keytruda and its impact on cancer care.

What is Keytruda?

Keytruda is a humanized monoclonal antibody that targets the PD-1 (programmed death-1) receptor on T cells. By blocking the PD-1 receptor, Keytruda enables the immune system to recognize and attack cancer cells more effectively. This mechanism of action has been shown to be highly effective in treating various types of cancer, including melanoma, non-small cell lung cancer (NSCLC), head and neck cancer, and more.

FDA Approval Date of Keytruda

Keytruda was first approved by the FDA on September 4, 2014, for the treatment of patients with unresectable or metastatic melanoma. This approval marked a significant milestone in the history of cancer treatment, as it was the first FDA approval of a PD-1 inhibitor.

Expansion of Indications

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

* Non-Small Cell Lung Cancer (NSCLC): Keytruda was approved for the treatment of patients with NSCLC in 2015.
* Head and Neck Cancer: Keytruda was approved for the treatment of patients with head and neck cancer in 2016.
* Classical Hodgkin Lymphoma: Keytruda was approved for the treatment of patients with classical Hodgkin lymphoma in 2017.
* Renal Cell Carcinoma: Keytruda was approved for the treatment of patients with renal cell carcinoma in 2019.
* Urothelial Carcinoma: Keytruda was approved for the treatment of patients with urothelial carcinoma in 2017.

Impact on Cancer Care

The approval of Keytruda has had a profound impact on cancer care, offering new hope to patients with various types of cancer. According to a study published in the Journal of Clinical Oncology, the approval of Keytruda has led to a significant increase in the use of immunotherapy in cancer treatment.

"The approval of Keytruda has been a game-changer in the treatment of cancer," says Dr. Roy Baynes, Senior Vice President and Head of Global Clinical Development, Merck Research Laboratories. "It has opened up new treatment options for patients with various types of cancer, and we are committed to continuing to explore its potential in other areas of cancer treatment."

Patent Expiration

According to DrugPatentWatch.com, the patent for Keytruda is set to expire in 2028. This has raised concerns about the potential for generic versions of the drug to enter the market, which could impact its sales and availability.

"The patent expiration of Keytruda is a significant concern for the pharmaceutical industry," says Dr. Eric Langer, President and CEO of BioSpace. "It highlights the need for companies to invest in research and development to stay ahead of the competition and maintain their market share."

Conclusion

In conclusion, the FDA approval date of Keytruda in cancer care is September 4, 2014. Since its initial approval, Keytruda has received numerous expansions of its indications, and its impact on cancer care has been profound. As the patent for Keytruda approaches expiration, companies are looking to invest in research and development to stay ahead of the competition.

Key Takeaways

* Keytruda was first approved by the FDA on September 4, 2014, for the treatment of patients with unresectable or metastatic melanoma.
* Keytruda has received numerous expansions of its indications, including NSCLC, head and neck cancer, classical Hodgkin lymphoma, renal cell carcinoma, and urothelial carcinoma.
* The approval of Keytruda has had a significant impact on cancer care, offering new hope to patients with various types of cancer.
* The patent for Keytruda is set to expire in 2028, which has raised concerns about the potential for generic versions of the drug to enter the market.

Frequently Asked Questions

1. What is Keytruda?
Keytruda is a humanized monoclonal antibody that targets the PD-1 receptor on T cells, enabling the immune system to recognize and attack cancer cells more effectively.
2. When was Keytruda first approved by the FDA?
Keytruda was first approved by the FDA on September 4, 2014, for the treatment of patients with unresectable or metastatic melanoma.
3. What are the indications for Keytruda?
Keytruda has been approved for the treatment of patients with NSCLC, head and neck cancer, classical Hodgkin lymphoma, renal cell carcinoma, and urothelial carcinoma.
4. What is the patent expiration date for Keytruda?
The patent for Keytruda is set to expire in 2028.
5. What is the impact of Keytruda on cancer care?
The approval of Keytruda has had a significant impact on cancer care, offering new hope to patients with various types of cancer.

Sources

1. Merck & Co., Inc. (2014). Keytruda (pembrolizumab) approved by FDA for treatment of unresectable or metastatic melanoma.
2. Journal of Clinical Oncology (2017). Pembrolizumab for the treatment of patients with unresectable or metastatic melanoma.
3. DrugPatentWatch.com. Patent expiration date for Keytruda (pembrolizumab).
4. BioSpace (2020). Patent expiration of Keytruda raises concerns for pharmaceutical industry.
5. Merck & Co., Inc. (2020). Keytruda (pembrolizumab) approved for treatment of patients with classical Hodgkin lymphoma.