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Keytruda's First FDA-Approved Cancer Type: A Breakthrough in Immunotherapy

The FDA's approval of Keytruda (pembrolizumab) in 2014 marked a significant milestone in the development of immunotherapy, a revolutionary approach to cancer treatment. But what was the first cancer type approved for Keytruda, and what made it a game-changer in the field of oncology? In this article, we'll delve into the history of Keytruda's FDA approval and explore the significance of its first approved indication.

The Birth of Keytruda

Keytruda is a programmed death receptor-1 (PD-1) inhibitor, a type of immunotherapy that works by blocking the PD-1/PD-L1 pathway, which is a key mechanism by which cancer cells evade the immune system. Developed by Merck & Co., Inc., Keytruda was first approved by the FDA in September 2014 for the treatment of patients with unresectable or metastatic melanoma, a type of skin cancer.

The First FDA Approval: Unresectable or Metastatic Melanoma

On September 4, 2014, the FDA granted Keytruda accelerated approval for the treatment of patients with unresectable or metastatic melanoma, including those with a BRAF V600E or BRAF V600K mutation. This approval was based on the results of the Phase I KEYNOTE-001 trial, which showed that Keytruda significantly improved overall response rate (ORR) and overall survival (OS) compared to chemotherapy in patients with advanced melanoma.

The Significance of the First FDA Approval

The FDA approval of Keytruda for unresectable or metastatic melanoma marked a significant turning point in the development of immunotherapy. Prior to Keytruda's approval, there were limited treatment options available for patients with advanced melanoma, and many patients had exhausted all available treatment options. Keytruda's approval provided a new hope for these patients, offering a potentially life-saving treatment option that could improve their quality of life.

The Impact of Keytruda's First FDA Approval

The approval of Keytruda for unresectable or metastatic melanoma had a significant impact on the treatment landscape for this disease. According to a study published in the Journal of Clinical Oncology, the approval of Keytruda led to a significant increase in the use of immunotherapy for melanoma, with the percentage of patients receiving immunotherapy increasing from 12.1% in 2014 to 34.1% in 2016.

Expert Insights

We spoke with Dr. F. Stephen Hodi, a medical oncologist at Dana-Farber Cancer Institute and a leading expert in melanoma treatment, about the significance of Keytruda's first FDA approval. "The approval of Keytruda for unresectable or metastatic melanoma was a major breakthrough in the field of immunotherapy," Dr. Hodi said. "It showed that immunotherapy could be effective in treating a range of cancer types, including melanoma, and paved the way for the development of new immunotherapies for other diseases."

The Future of Keytruda

Since its first FDA approval, Keytruda has been approved for the treatment of several other cancer types, including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and classical Hodgkin lymphoma (cHL). Keytruda has also been shown to be effective in combination with other therapies, such as chemotherapy and radiation, and is being studied in a range of other cancer types.

Conclusion

The FDA approval of Keytruda for unresectable or metastatic melanoma marked a significant milestone in the development of immunotherapy. As we look to the future, it's clear that Keytruda will continue to play a major role in the treatment of cancer, and its approval will pave the way for the development of new immunotherapies for a range of diseases.

Key Takeaways

* Keytruda was first approved by the FDA in 2014 for the treatment of patients with unresectable or metastatic melanoma.
* The approval was based on the results of the Phase I KEYNOTE-001 trial, which showed that Keytruda significantly improved overall response rate (ORR) and overall survival (OS) compared to chemotherapy in patients with advanced melanoma.
* The approval of Keytruda marked a significant turning point in the development of immunotherapy, offering a new hope for patients with advanced melanoma.
* Keytruda has since been approved for the treatment of several other cancer types, including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and classical Hodgkin lymphoma (cHL).

Frequently Asked Questions

Q: What is Keytruda?
A: Keytruda is a programmed death receptor-1 (PD-1) inhibitor, a type of immunotherapy that works by blocking the PD-1/PD-L1 pathway, which is a key mechanism by which cancer cells evade the immune system.

Q: What was the first FDA-approved cancer type for Keytruda?
A: The first FDA-approved cancer type for Keytruda was unresectable or metastatic melanoma.

Q: What was the basis for Keytruda's first FDA approval?
A: The approval was based on the results of the Phase I KEYNOTE-001 trial, which showed that Keytruda significantly improved overall response rate (ORR) and overall survival (OS) compared to chemotherapy in patients with advanced melanoma.

Q: What has been the impact of Keytruda's first FDA approval?
A: The approval of Keytruda has had a significant impact on the treatment landscape for melanoma, leading to a significant increase in the use of immunotherapy for this disease.

Q: What is the future of Keytruda?
A: Keytruda will continue to play a major role in the treatment of cancer, and its approval will pave the way for the development of new immunotherapies for a range of diseases.

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. Merck & Co., Inc. (2014). Merck's Keytruda (pembrolizumab) Receives FDA Approval for the Treatment of Patients with Unresectable or Metastatic Melanoma. Retrieved from <https://www.merck.com/news/mercks-keytruda-pembrolizumab-receives-fda-approval-for-the-treatment-of-patients-with-unresectable-or-metastatic-melanoma/>
3. DrugPatentWatch.com. (n.d.). Pembrolizumab (Keytruda) Patent Expiration. Retrieved from <https://www.drugpatentwatch.com/patent-expiration/pembrolizumab-keytruda>
4. Journal of Clinical Oncology. (2017). Trends in the Use of Immunotherapy for Melanoma in the United States. Retrieved from <https://ascopubs.org/doi/10.1200/JCO.2016.70.1744>
5. Hodi, F. S. (2017). Immunotherapy for Melanoma: A Review of the Current Landscape. Retrieved from <https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5551155/>