See the DrugPatentWatch profile for keytruda
Keytruda: A Breakthrough in Cancer Treatment
A Journey to FDA Approval
In the realm of cancer treatment, there have been numerous breakthroughs in recent years, and one of the most significant ones is the approval of Keytruda (pembrolizumab) by the US Food and Drug Administration (FDA). But when did Keytruda receive FDA approval for cancer treatment?
Early Beginnings
Keytruda, developed by Merck & Co., Inc., is a monoclonal antibody that targets the PD-1 protein on T-cells, allowing them to recognize and attack cancer cells. The journey to FDA approval began in 2006, when Merck & Co., Inc. initiated a research collaboration with the University of Pennsylvania to develop a PD-1 inhibitor.
Phase I Clinical Trials
In 2011, Merck & Co., Inc. initiated Phase I clinical trials for Keytruda in patients with advanced melanoma. The trials showed promising results, with some patients experiencing significant tumor shrinkage and improved survival rates.
Accelerated Approval
On September 4, 2014, the FDA granted accelerated approval to Keytruda for the treatment of patients with metastatic melanoma who have progressed after ipilimumab and, if BRAF V600 mutation-positive, a BRAF inhibitor. This marked a significant milestone in the development of Keytruda.
Expansion of Indications
Since its initial approval, Keytruda has received several expansions of indications for various types of cancer, including:
* Non-Small Cell Lung Cancer (NSCLC)
: On October 2, 2015, the FDA approved Keytruda for the treatment of patients with metastatic NSCLC whose tumors express PD-L1.
* Head and Neck Squamous Cell Carcinoma (HNSCC)
: On March 23, 2016, the FDA approved Keytruda for the treatment of patients with HNSCC whose tumors express PD-L1.
* Renal Cell Carcinoma (RCC)
: On November 23, 2016, the FDA approved Keytruda for the treatment of patients with RCC who have received prior anti-angiogenic therapy.
Keytruda's Impact on Cancer Treatment
Keytruda's approval has revolutionized the treatment of various types of cancer, offering patients a new hope for improved survival rates and quality of life. According to a study published in the Journal of Clinical Oncology, Keytruda has shown significant efficacy in treating patients with advanced melanoma, with a response rate of 33% and a median overall survival of 10.5 months.
Industry Expert Insights
"We are thrilled with the approval of Keytruda, which has the potential to change the treatment landscape for patients with various types of cancer," said Dr. Roger M. Perlmutter, President of Merck Research Laboratories. "Our commitment to developing innovative treatments like Keytruda is unwavering, and we look forward to continuing to bring new hope to patients worldwide."
Patent Expiration and Generic Competition
According to DrugPatentWatch.com, the patent for Keytruda is set to expire in 2028. This may lead to generic competition, which could impact the drug's market share and pricing. However, Merck & Co., Inc. has filed several patent applications to extend the patent protection for Keytruda.
Conclusion
Keytruda's journey to FDA approval has been a remarkable one, marked by significant breakthroughs in cancer treatment. With its expanded indications and promising efficacy, Keytruda has become a game-changer in the fight against cancer. As the patent expiration approaches, it will be interesting to see how the market dynamics change and how Merck & Co., Inc. adapts to the competition.
Key Takeaways
* Keytruda received FDA approval for the treatment of metastatic melanoma in 2014.
* The drug has received several expansions of indications for various types of cancer, including NSCLC, HNSCC, and RCC.
* Keytruda has shown significant efficacy in treating patients with advanced melanoma, with a response rate of 33% and a median overall survival of 10.5 months.
* The patent for Keytruda is set to expire in 2028, which may lead to generic competition.
FAQs
Q: What is Keytruda, and how does it work?
A: Keytruda is a monoclonal antibody that targets the PD-1 protein on T-cells, allowing them to recognize and attack cancer cells.
Q: What types of cancer is Keytruda approved for?
A: Keytruda is approved for the treatment of metastatic melanoma, NSCLC, HNSCC, and RCC.
Q: What are the potential side effects of Keytruda?
A: Common side effects of Keytruda include fatigue, diarrhea, and rash.
Q: How long is the patent for Keytruda?
A: The patent for Keytruda is set to expire in 2028.
Q: Will generic competition impact the market share and pricing of Keytruda?
A: Yes, generic competition may impact the market share and pricing of Keytruda.
Sources:
1. Merck & Co., Inc. (2014). Merck Announces FDA Accelerated Approval of KEYTRUDA (pembrolizumab) for Patients with Metastatic Melanoma.
2. FDA (2014). FDA Approves KEYTRUDA (pembrolizumab) for Patients with Metastatic Melanoma.
3. DrugPatentWatch.com. (n.d.). Pembrolizumab (KEYTRUDA) Patent Expiration.
4. Journal of Clinical Oncology (2015). Pembrolizumab in Patients with Advanced Melanoma.
5. Merck & Co., Inc. (2016). Merck Announces FDA Approval of KEYTRUDA (pembrolizumab) for Patients with Head and Neck Squamous Cell Carcinoma.