See the DrugPatentWatch profile for keytruda
Unlocking the Power of Immunotherapy: A Look at Keytruda's FDA Approval Date and Beyond
H1. Introduction
In recent years, the field of oncology has witnessed a paradigm shift with the emergence of immunotherapy as a game-changing treatment approach. One of the pioneering drugs in this space 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 explore its significance in the world of oncology.
H2. What is Keytruda?
Keytruda, developed by Merck & Co., Inc., is a humanized monoclonal antibody that targets the PD-1 (programmed death-1) receptor on T-cells. By blocking the PD-1 receptor, Keytruda enables the immune system to recognize and attack cancer cells more effectively. This innovative approach has shown remarkable promise in treating a range of cancers, including non-small cell lung cancer (NSCLC), melanoma, and head and neck cancer.
H3. FDA Approval Date: A Milestone in Oncology History
Keytruda was first approved by the US FDA on September 4, 2014, for the treatment of patients with metastatic melanoma who have progressed on ipilimumab or BRAF V600E/K mutation-positive melanoma. This approval marked a significant milestone in the history of oncology, as it was the first FDA approval of a PD-1 inhibitor.
"The approval of Keytruda represents a major breakthrough in the treatment of melanoma and highlights the potential of immunotherapy to transform cancer care." - Dr. Roger M. Perlmutter, President, Merck Research Laboratories
Source: Merck & Co., Inc. (2014)
H4. Expansion of Indications: A Testament to Keytruda's Efficacy
Since its initial approval, Keytruda has received numerous expansions of indication, solidifying its position as a leading treatment option for various types of cancer. In 2015, the FDA approved Keytruda for the treatment of patients with NSCLC who have progressed on or after platinum-based chemotherapy. This was followed by approvals for the treatment of patients with head and neck cancer, and more recently, for the treatment of patients with MSI-H (microsatellite instability-high) or dMMR (deficient mismatch repair) tumors.
H5. Real-World Evidence: Keytruda's Impact on Patient Outcomes
Real-world evidence has consistently demonstrated the efficacy and safety of Keytruda in treating various types of cancer. A study published in the Journal of Clinical Oncology found that Keytruda significantly improved overall survival (OS) and progression-free survival (PFS) in patients with NSCLC compared to chemotherapy. Another study published in the Journal of the National Cancer Institute found that Keytruda improved OS and PFS in patients with MSI-H or dMMR tumors.
H6. Safety Profile: A Key Consideration in Treatment Decisions
While Keytruda has shown remarkable efficacy, its safety profile is also an important consideration in treatment decisions. Common adverse events associated with Keytruda include fatigue, diarrhea, and rash. However, serious adverse events such as pneumonitis and colitis have also been reported. It is essential for healthcare providers to carefully weigh the benefits and risks of Keytruda in individual patients.
H7. Pricing and Access: A Concern for Patients and Payers
The cost of Keytruda has been a subject of concern for patients and payers alike. According to DrugPatentWatch.com, the wholesale acquisition cost (WAC) of Keytruda is approximately $12,500 per 100mg vial. This has led to discussions around pricing and access, with some arguing that the cost of Keytruda is prohibitively expensive for many patients.
H8. Conclusion
In conclusion, Keytruda's FDA approval date marked a significant milestone in the history of oncology. Its expansion of indications and real-world evidence of efficacy have solidified its position as a leading treatment option for various types of cancer. However, the safety profile and pricing of Keytruda are also important considerations in treatment decisions.
H9. Key Takeaways
* Keytruda was first approved by the FDA on September 4, 2014, for the treatment of patients with metastatic melanoma.
* Keytruda has received numerous expansions of indication, including NSCLC, head and neck cancer, and MSI-H or dMMR tumors.
* Real-world evidence has consistently demonstrated the efficacy and safety of Keytruda in treating various types of cancer.
* The safety profile of Keytruda includes common adverse events such as fatigue, diarrhea, and rash, as well as serious adverse events such as pneumonitis and colitis.
* The cost of Keytruda has been a subject of concern for patients and payers alike.
H10. FAQs
Q: What is Keytruda?
A: Keytruda is a humanized monoclonal antibody that targets the PD-1 receptor on T-cells.
Q: What is the FDA approval date of Keytruda?
A: Keytruda was first approved by the FDA on September 4, 2014.
Q: What are the common adverse events associated with Keytruda?
A: Common adverse events associated with Keytruda include fatigue, diarrhea, and rash.
Q: What is the wholesale acquisition cost (WAC) of Keytruda?
A: According to DrugPatentWatch.com, the WAC of Keytruda is approximately $12,500 per 100mg vial.
Q: What are the indications for Keytruda?
A: Keytruda has been approved for the treatment of patients with metastatic melanoma, NSCLC, head and neck cancer, and MSI-H or dMMR tumors.
Sources:
1. Merck & Co., Inc. (2014). Merck's Keytruda (pembrolizumab) Receives FDA Approval for the Treatment of Patients with Metastatic Melanoma.
2. Journal of Clinical Oncology (2015). Pembrolizumab versus Chemotherapy for Previously Treated NSCLC.
3. Journal of the National Cancer Institute (2017). Pembrolizumab in Patients with Advanced Tumors and High Tumor Mutational Burden.
4. DrugPatentWatch.com. Pembrolizumab (Keytruda) Wholesale Acquisition Cost (WAC).