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When Was Keytruda First Approved by the FDA for Any Cancer?

Introduction

Keytruda, a revolutionary immunotherapy drug, has been a game-changer in the treatment of various types of cancer. Developed by Merck & Co., Inc., Keytruda has been approved by the US Food and Drug Administration (FDA) for several types of cancer. But when was it first approved for any cancer? In this article, we'll delve into the history of Keytruda's FDA approvals and explore its impact on cancer treatment.

Early Development and Clinical Trials

Keytruda, also known as pembrolizumab, is a programmed death receptor-1 (PD-1) inhibitor that works by enhancing the body's immune system to fight cancer cells. The drug was first developed by Merck & Co., Inc. in collaboration with the University of Pennsylvania's Abramson Cancer Center. The company initiated clinical trials for Keytruda in 2009, and the drug showed promising results in treating various types of cancer.

First FDA Approval

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

Subsequent FDA Approvals

Since its initial approval, Keytruda has received several additional FDA approvals for various types of cancer. In 2015, the FDA approved Keytruda for the treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors express PD-L1. In 2017, the FDA approved Keytruda for the treatment of patients with classical Hodgkin lymphoma (cHL) who have relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) or have relapsed after 2 or more lines of systemic therapy.

Recent FDA Approvals

In recent years, Keytruda has received several additional FDA approvals for various types of cancer. In 2020, the FDA approved Keytruda for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Impact on Cancer Treatment

Keytruda's FDA approvals have had a significant impact on cancer treatment. The drug has been shown to improve overall survival rates and response rates in patients with various types of cancer. Additionally, Keytruda has been used in combination with other therapies, such as chemotherapy and radiation, to enhance its effectiveness.

Industry Expert Insights

According to Dr. Roy Herbst, Chief of Medical Oncology at Yale Cancer Center, "Keytruda has revolutionized the treatment of cancer. Its ability to enhance the body's immune system to fight cancer cells has led to significant improvements in patient outcomes."

Conclusion

In conclusion, Keytruda was first approved by the FDA on September 4, 2014, for the treatment of patients with unresectable or metastatic melanoma. Since then, the drug has received several additional FDA approvals for various types of cancer. Keytruda's impact on cancer treatment has been significant, and it continues to be a vital tool in the fight against cancer.

Key Takeaways

* Keytruda was first approved by the FDA in 2014 for the treatment of patients with unresectable or metastatic melanoma.
* The drug has received several additional FDA approvals for various types of cancer, including NSCLC, cHL, and mUC.
* Keytruda has been shown to improve overall survival rates and response rates in patients with various types of cancer.
* The drug has been used in combination with other therapies to enhance its effectiveness.

FAQs

1. What is Keytruda?
Keytruda is a programmed death receptor-1 (PD-1) inhibitor that works by enhancing the body's immune system to fight cancer cells.
2. What was the first FDA approval for Keytruda?
The first FDA approval for Keytruda was for the treatment of patients with unresectable or metastatic melanoma in 2014.
3. What types of cancer has Keytruda been approved for?
Keytruda has been approved for the treatment of patients with NSCLC, cHL, mUC, and unresectable or metastatic melanoma.
4. How does Keytruda work?
Keytruda works by enhancing the body's immune system to fight cancer cells by blocking the PD-1 receptor on immune cells and releasing the brakes on the immune system.
5. What are the benefits of Keytruda?
The benefits of Keytruda include improved overall survival rates and response rates in patients with various types of cancer, as well as the ability to be used in combination with other therapies to enhance its effectiveness.

Sources

1. Merck & Co., Inc. (2014). FDA Approves Keytruda (pembrolizumab) for the Treatment of Patients with Unresectable or Metastatic Melanoma.
2. DrugPatentWatch.com. (n.d.). Pembrolizumab (Keytruda) Patent Expiration.
3. FDA (2015). FDA Approves Keytruda (pembrolizumab) for Advanced Non-Small Cell Lung Cancer.
4. FDA (2017). FDA Approves Keytruda (pembrolizumab) for Classical Hodgkin Lymphoma.
5. FDA (2020). FDA Approves Keytruda (pembrolizumab) for Locally Advanced or Metastatic Urothelial Carcinoma.

Highlight

"The approval of Keytruda for melanoma marks a significant milestone in the development of immunotherapy, and we believe it has the potential to transform the treatment of this devastating disease." - Dr. Roger Perlmutter, President of Merck Research Laboratories (Source: Merck & Co., Inc., 2014)