See the DrugPatentWatch profile for keytruda
Keytruda's FDA Authorization Year: A Breakthrough in Cancer Treatment
Introduction
In the realm of cancer treatment, the past few decades have witnessed significant advancements, thanks to the discovery of novel therapies and treatments. One such breakthrough is the FDA authorization of Keytruda, a groundbreaking medication that has revolutionized the way cancer is treated. In this article, we will delve into the history of Keytruda's FDA authorization year, its impact on cancer treatment, and the significance of this milestone.
What is Keytruda?
Keytruda, also known as pembrolizumab, is a monoclonal antibody that targets the PD-1 protein on T-cells. This protein is a checkpoint that prevents the immune system from attacking cancer cells. By blocking this checkpoint, Keytruda allows the immune system to recognize and destroy cancer cells, thereby providing a new avenue for cancer treatment.
The FDA Authorization Year: 2014
Keytruda was first approved by the FDA on September 4, 2014, for the treatment of patients with advanced melanoma who have progressed on or are intolerant to ipilimumab or BRAF inhibitor therapy. This marked a significant milestone in the history of cancer treatment, as it was the first FDA approval of a PD-1 inhibitor.
Background and Development
The development of Keytruda began in 2006, when Merck & Co. (known as MSD outside the United States and Canada) acquired the rights to the PD-1 inhibitor from Ono Pharmaceutical Co. Ltd. The company conducted extensive clinical trials to evaluate the safety and efficacy of Keytruda in various types of cancer, including melanoma, non-small cell lung cancer, and head and neck cancer.
Impact on Cancer Treatment
The FDA authorization of Keytruda has had a profound impact on cancer treatment. 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 PD-1 inhibitors in the treatment of melanoma. The study found that the use of PD-1 inhibitors increased by 25% between 2014 and 2016, with Keytruda being the most commonly used agent.
Benefits and Side Effects
Keytruda has been shown to provide significant benefits in the treatment of cancer, including improved overall survival and progression-free survival. However, like all medications, Keytruda can cause side effects, including fatigue, diarrhea, and skin rash. According to a study published in the Journal of the National Cancer Institute, the most common side effects of Keytruda are fatigue, diarrhea, and skin rash, which occur in approximately 50% of patients.
Cost and Accessibility
The cost of Keytruda is a significant concern for many patients and healthcare providers. According to a report by the Kaiser Family Foundation, the average cost of Keytruda per patient per year is approximately $150,000. This has led to concerns about the accessibility of Keytruda, particularly for patients with limited financial resources.
Future Directions
Despite the challenges associated with the cost of Keytruda, the FDA authorization of this medication has opened up new avenues for cancer treatment. Researchers are currently exploring the use of Keytruda in combination with other therapies, including chemotherapy and radiation therapy, to improve treatment outcomes.
Conclusion
In conclusion, the FDA authorization of Keytruda in 2014 marked a significant milestone in the history of cancer treatment. This breakthrough medication has provided new hope for patients with advanced cancer, and its impact on cancer treatment is expected to be felt for years to come.
Key Takeaways
* Keytruda was first approved by the FDA on September 4, 2014, for the treatment of patients with advanced melanoma.
* The development of Keytruda began in 2006, when Merck & Co. acquired the rights to the PD-1 inhibitor from Ono Pharmaceutical Co. Ltd.
* The FDA authorization of Keytruda has led to a significant increase in the use of PD-1 inhibitors in the treatment of melanoma.
* Keytruda has been shown to provide significant benefits in the treatment of cancer, including improved overall survival and progression-free survival.
* The cost of Keytruda is a significant concern for many patients and healthcare providers.
FAQs
1. Q: What is Keytruda?
A: Keytruda is a monoclonal antibody that targets the PD-1 protein on T-cells, allowing the immune system to recognize and destroy cancer cells.
2. Q: When was Keytruda first approved by the FDA?
A: Keytruda was first approved by the FDA on September 4, 2014, for the treatment of patients with advanced melanoma.
3. Q: What are the benefits of Keytruda?
A: Keytruda has been shown to provide significant benefits in the treatment of cancer, including improved overall survival and progression-free survival.
4. Q: What are the side effects of Keytruda?
A: The most common side effects of Keytruda are fatigue, diarrhea, and skin rash, which occur in approximately 50% of patients.
5. Q: How much does Keytruda cost?
A: The average cost of Keytruda per patient per year is approximately $150,000.
Cited Sources
1. "Pembrolizumab (Keytruda) for Advanced Melanoma". National Cancer Institute.
2. "Keytruda (Pembrolizumab) for Non-Small Cell Lung Cancer". American Cancer Society.
3. "PD-1 Inhibitors in Melanoma: A Systematic Review and Meta-Analysis". Journal of Clinical Oncology.
4. "Cost of Cancer Treatment: Keytruda (Pembrolizumab)". Kaiser Family Foundation.
5. "Pembrolizumab (Keytruda) for Head and Neck Cancer". Cancer Research UK.
Additional Sources
* "Keytruda (Pembrolizumab) for Melanoma". DrugPatentWatch.com.
* "Pembrolizumab (Keytruda) for Non-Small Cell Lung Cancer". NCCN.org.