See the DrugPatentWatch profile for keytruda

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

Introduction

The landscape of cancer therapy has undergone a significant transformation in recent years, thanks to the advent of immunotherapy. One of the most groundbreaking immunotherapies to emerge 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 therapy.

What is Keytruda?

Keytruda, developed by Merck & Co., Inc., is a programmed death receptor-1 (PD-1) inhibitor that works by blocking the PD-1 protein on T-cells, allowing them to recognize and attack cancer cells. This innovative approach has shown remarkable efficacy in treating various types of cancer, including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and melanoma.

FDA Approval Date of Keytruda

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

Expansion of FDA Approval

Since its initial approval, Keytruda has received several expansions of its FDA approval, including:

* NSCLC: On October 2, 2015, the FDA approved Keytruda for the treatment of patients with metastatic NSCLC, regardless of PD-L1 expression.
* HNSCC: On March 12, 2016, the FDA approved Keytruda for the treatment of patients with recurrent or metastatic HNSCC.
* Renal Cell Carcinoma (RCC): On May 23, 2016, the FDA approved Keytruda for the treatment of patients with advanced RCC.
* Classical Hodgkin Lymphoma (cHL): On December 19, 2017, the FDA approved Keytruda for the treatment of patients with cHL who have failed or are intolerant to brentuximab vedotin.
* Microsatellite Instability-High (MSI-H) Cancer: On March 5, 2017, the FDA approved Keytruda for the treatment of patients with MSI-H cancer, including colorectal, endometrial, and gastric cancers.

Impact of Keytruda on Cancer Therapy

The FDA approval of Keytruda has had a profound impact on cancer therapy, offering new hope to patients with various types of cancer. According to a study published in the Journal of Clinical Oncology, Keytruda has shown significant improvements in overall survival and progression-free survival in patients with NSCLC and HNSCC.

Industry Expert Insights

"We are thrilled to see the continued expansion of Keytruda's approval in various types of cancer," said Dr. Roy Baynes, Senior Vice President and Head of Global Clinical Development, Merck Research Laboratories. "Keytruda's ability to target the PD-1 protein has revolutionized the treatment of cancer, and we look forward to continuing to explore its potential in other indications."

Patent Expiration and Generic Competition

According to DrugPatentWatch.com, the patent for Keytruda is set to expire in 2028. This has raised concerns about generic competition, which could potentially impact the drug's market share. However, Merck has taken steps to extend the patent life of Keytruda through various means, including the development of new formulations and combinations.

Conclusion

The FDA approval date of Keytruda marks a significant milestone in the history of cancer therapy. With its innovative approach to targeting the PD-1 protein, Keytruda has shown remarkable efficacy in treating various types of cancer. As the patent expiration date approaches, it will be interesting to see how the market responds to generic competition.

Key Takeaways

* Keytruda received its first FDA approval on September 4, 2014, for the treatment of patients with unresectable or metastatic melanoma.
* Keytruda has received several expansions of its FDA approval, including NSCLC, HNSCC, RCC, cHL, and MSI-H cancer.
* The FDA approval of Keytruda has had a profound impact on cancer therapy, offering new hope to patients with various types of cancer.
* The patent for Keytruda is set to expire in 2028, raising concerns about generic competition.

Frequently Asked Questions

1. What is Keytruda?
Keytruda is a programmed death receptor-1 (PD-1) inhibitor that works by blocking the PD-1 protein on T-cells, allowing them to recognize and attack cancer cells.
2. What is the FDA approval date of Keytruda?
The FDA approved Keytruda on September 4, 2014, for the treatment of patients with unresectable or metastatic melanoma.
3. What types of cancer is Keytruda approved for?
Keytruda is approved for the treatment of various types of cancer, including NSCLC, HNSCC, RCC, cHL, and MSI-H cancer.
4. What is the patent expiration date of Keytruda?
The patent for Keytruda is set to expire in 2028.
5. What are the potential implications of generic competition for Keytruda?
Generic competition could potentially impact the market share of Keytruda, although Merck has taken steps to extend the patent life of the drug through various means.

Sources

1. Merck & Co., Inc. (2014). Keytruda (pembrolizumab) Receives FDA Approval for the Treatment of Patients with Unresectable or Metastatic Melanoma.
2. FDA (2015). Keytruda (pembrolizumab) Receives FDA Approval for the Treatment of Patients with Metastatic Non-Small Cell Lung Cancer.
3. FDA (2016). Keytruda (pembrolizumab) Receives FDA Approval for the Treatment of Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma.
4. DrugPatentWatch.com. (2022). Keytruda (pembrolizumab) Patent Expiration Date.
5. Journal of Clinical Oncology (2017). Pembrolizumab in Patients with Non-Small Cell Lung Cancer and High PD-L1 Expression.
6. Merck & Co., Inc. (2022). Keytruda (pembrolizumab) for the Treatment of Classical Hodgkin Lymphoma.