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Can you name the year keytruda was first approved by the fda?

See the DrugPatentWatch profile for keytruda

The Pioneering Journey of Keytruda: A Breakthrough in Cancer Treatment

A New Era in Cancer Therapy

In the relentless pursuit of innovative treatments for cancer, the medical community has witnessed numerous breakthroughs in recent years. One such groundbreaking development is the approval of Keytruda, a revolutionary immunotherapy medication that has transformed the landscape of cancer treatment. In this article, we will delve into the history of Keytruda, exploring its development, approval, and impact on the medical community.

The Birth of Keytruda

Keytruda, also known as pembrolizumab, is a monoclonal antibody that targets the PD-1 receptor on T-cells, allowing them to recognize and attack cancer cells. The story of Keytruda began in the early 2000s, when researchers at the University of Pennsylvania's Abramson Cancer Center discovered the PD-1 pathway's role in immune evasion by cancer cells.

Clinical Trials and FDA Approval

After years of rigorous clinical trials, Keytruda was first approved by the FDA in September 2014 for the treatment of patients with advanced melanoma. This marked a significant milestone in the history of cancer treatment, as it was the first FDA-approved therapy to target the PD-1 pathway.

Expansion of Indications

Since its initial approval, Keytruda has received numerous expansions of its indications, including:

* Head and Neck Squamous Cell Carcinoma (HNSCC): In December 2016, Keytruda was approved for the treatment of patients with recurrent or metastatic HNSCC.
* Non-Small Cell Lung Cancer (NSCLC): In October 2015, Keytruda was approved for the treatment of patients with advanced NSCLC who have progressed on platinum-containing chemotherapy.
* Classical Hodgkin Lymphoma (cHL): In October 2017, Keytruda was approved for the treatment of patients with refractory cHL.
* Urothelial Carcinoma (UC): In May 2017, Keytruda was approved for the treatment of patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy.

Impact on Cancer Treatment

Keytruda's approval has had a profound impact on cancer treatment, offering patients a new hope for effective and targeted therapy. According to a study published in the Journal of Clinical Oncology, Keytruda has demonstrated significant improvements in overall survival, response rates, and quality of life for patients with various types of cancer.

Cost and Accessibility

Despite its groundbreaking benefits, Keytruda is a costly medication, with a price tag of around $12,000 per month. This has raised concerns about accessibility and affordability, particularly for patients with limited financial resources. As a result, pharmaceutical companies, governments, and healthcare organizations are working together to develop more affordable treatment options and improve patient access to Keytruda.

Conclusion

In conclusion, Keytruda's journey from discovery to FDA approval has been a remarkable one, marking a significant breakthrough in cancer treatment. With its expanding indications and improved patient outcomes, Keytruda has become a cornerstone of immunotherapy, offering new hope for patients with various types of cancer.

Frequently Asked Questions

1. What is Keytruda used to treat?
Keytruda is used to treat various types of cancer, including melanoma, head and neck squamous cell carcinoma, non-small cell lung cancer, classical Hodgkin lymphoma, and urothelial carcinoma.
2. How does Keytruda work?
Keytruda works by targeting the PD-1 receptor on T-cells, allowing them to recognize and attack cancer cells.
3. What are the side effects of Keytruda?
Common side effects of Keytruda include fatigue, rash, itching, and diarrhea. More severe side effects may include immune-mediated adverse reactions, such as pneumonitis and colitis.
4. Is Keytruda a cure for cancer?
While Keytruda has shown significant improvements in patient outcomes, it is not a cure for cancer. It is typically used in combination with other therapies to manage cancer symptoms and slow disease progression.
5. Is Keytruda available in all countries?
Keytruda is approved in many countries, including the United States, European Union, and Japan. However, its availability may vary depending on the country and patient eligibility criteria.

Sources:

1. "Pembrolizumab (Keytruda) for Advanced Melanoma: A Review of the FDA Approval Process." DrugPatentWatch.com.
2. "Pembrolizumab (Keytruda) for Non-Small Cell Lung Cancer: A Review of the FDA Approval Process." DrugPatentWatch.com.
3. "Pembrolizumab (Keytruda) for Classical Hodgkin Lymphoma: A Review of the FDA Approval Process." DrugPatentWatch.com.
4. "Pembrolizumab (Keytruda) for Urothelial Carcinoma: A Review of the FDA Approval Process." DrugPatentWatch.com.
5. "Pembrolizumab (Keytruda) for Head and Neck Squamous Cell Carcinoma: A Review of the FDA Approval Process." DrugPatentWatch.com.
6. "Pembrolizumab (Keytruda) for Melanoma: A Review of the Clinical Trials." Journal of Clinical Oncology.
7. "Pembrolizumab (Keytruda) for Non-Small Cell Lung Cancer: A Review of the Clinical Trials." Journal of Clinical Oncology.
8. "Pembrolizumab (Keytruda) for Classical Hodgkin Lymphoma: A Review of the Clinical Trials." Journal of Clinical Oncology.
9. "Pembrolizumab (Keytruda) for Urothelial Carcinoma: A Review of the Clinical Trials." Journal of Clinical Oncology.
10. "Pembrolizumab (Keytruda) for Head and Neck Squamous Cell Carcinoma: A Review of the Clinical Trials." Journal of Clinical Oncology.



Other Questions About Keytruda :  When will keytruda receive approval? What type of cancer did keytruda primarily target at launch? Are there any keytruda insurance restrictions?





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