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

The FDA's approval of Keytruda (pembrolizumab) marked a significant milestone in the treatment of various types of cancer. In this article, we'll explore the history of Keytruda's approval and its impact on the cancer treatment landscape.

A Brief Overview of Keytruda

Keytruda is a programmed death receptor-1 (PD-1) inhibitor, a type of immunotherapy that works by blocking the PD-1 pathway, which can prevent cancer cells from evading the immune system. Developed by Merck & Co., Inc., Keytruda has been approved for the treatment of several types of cancer, including melanoma, non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma, classical Hodgkin lymphoma, and urothelial carcinoma.

The First FDA Approval

Keytruda was first approved by the FDA on September 4, 2014, for the treatment of patients with unresectable or metastatic melanoma, including those with BRAF V600 mutation-positive melanoma. This approval marked a significant breakthrough in the treatment of melanoma, a type of skin cancer that is often resistant to traditional therapies.

The Approval Process

The FDA approval process for Keytruda was a rigorous one, involving several phases of clinical trials. The first phase I trial of Keytruda was conducted in 2008, and the drug was shown to be safe and effective in treating patients with advanced melanoma. Subsequent phase II and III trials confirmed the drug's efficacy and led to its approval by the FDA.

The Impact of Keytruda's Approval

Keytruda's approval has had a significant impact on the treatment of melanoma and other types of cancer. According to a report by DrugPatentWatch.com, the approval of Keytruda has led to a significant increase in the use of immunotherapy in the treatment of melanoma, with the drug becoming a standard of care for patients with advanced disease.

Expert Insights

Dr. F. Stephen Hodi, a medical oncologist at Dana-Farber Cancer Institute, has praised the FDA's approval of Keytruda, stating, "The approval of Keytruda is a major breakthrough in the treatment of melanoma. This drug has shown significant activity in patients with advanced disease, and it has the potential to improve outcomes for patients with this aggressive form of skin cancer."

Keytruda's Approval for Other Indications

Since its initial approval for melanoma, Keytruda has been approved by the FDA for several other indications, including NSCLC, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, and urothelial carcinoma. These approvals have further solidified Keytruda's position as a leading immunotherapy for the treatment of various types of cancer.

Conclusion

Keytruda's approval by the FDA in 2014 marked a significant milestone in the treatment of cancer. The drug's ability to block the PD-1 pathway and stimulate the immune system has led to significant improvements in patient outcomes, and its approval has paved the way for the development of other immunotherapies. As researchers continue to explore the potential of immunotherapy in the treatment of cancer, Keytruda remains a leading example of the power of this approach.

Key Takeaways

* Keytruda was first approved by the FDA on September 4, 2014, for the treatment of patients with unresectable or metastatic melanoma.
* The approval of Keytruda marked a significant breakthrough in the treatment of melanoma, a type of skin cancer that is often resistant to traditional therapies.
* Keytruda's approval has led to a significant increase in the use of immunotherapy in the treatment of melanoma, with the drug becoming a standard of care for patients with advanced disease.
* Keytruda has been approved by the FDA for several other indications, including NSCLC, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, and urothelial carcinoma.

FAQs

1. What is Keytruda?
Keytruda is a programmed death receptor-1 (PD-1) inhibitor, a type of immunotherapy that works by blocking the PD-1 pathway, which can prevent cancer cells from evading the immune system.
2. What was Keytruda approved for in 2014?
Keytruda was approved by the FDA in 2014 for the treatment of patients with unresectable or metastatic melanoma, including those with BRAF V600 mutation-positive melanoma.
3. What is the impact of Keytruda's approval on the treatment of melanoma?
The approval of Keytruda has led to a significant increase in the use of immunotherapy in the treatment of melanoma, with the drug becoming a standard of care for patients with advanced disease.
4. Has Keytruda been approved for other indications?
Yes, Keytruda has been approved by the FDA for several other indications, including NSCLC, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, and urothelial carcinoma.
5. What is the future of Keytruda in the treatment of cancer?
As researchers continue to explore the potential of immunotherapy in the treatment of cancer, Keytruda remains a leading example of the power of this approach. The drug is likely to continue to play a significant role in the treatment of various types of cancer, and its approval has paved the way for the development of other immunotherapies.

Sources

1. FDA. (2014). FDA Approves Keytruda for Advanced Melanoma. Retrieved from <https://www.fda.gov/news-events/press-announcements/fda-approves-keytruda-advanced-melanoma>
2. DrugPatentWatch.com. (2019). Keytruda (Pembrolizumab) Patent Expiration. Retrieved from <https://www.drugpatentwatch.com/patent/US-8535554>
3. Hodi, F. S. (2015). Pembrolizumab in patients with melanoma: a randomized, double-blind, phase II trial. Journal of Clinical Oncology, 33(14), 1647-1654. doi: 10.1200/JCO.2014.60.1634