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When Was Keytruda's First FDA Approval Granted?

A Breakthrough in Cancer Treatment

Keytruda, a revolutionary immunotherapy medication, has been a game-changer in the fight against cancer. Developed by Merck & Co., Inc., Keytruda has been approved by the US Food and Drug Administration (FDA) for the treatment of various types of cancer. But when was Keytruda's first FDA approval granted?

The Early Years of Keytruda

Keytruda, also known as pembrolizumab, is a programmed death receptor-1 (PD-1) inhibitor. It works by blocking the PD-1 pathway, which allows the immune system to recognize and attack cancer cells. The medication was first discovered in the early 2000s by researchers at the University of California, Los Angeles (UCLA).

FDA Approval: A Long and Winding Road

Keytruda's journey to FDA approval was not without its challenges. The medication underwent extensive clinical trials, involving thousands of patients worldwide. The FDA requires rigorous testing to ensure that a medication is safe and effective for human use.

First FDA Approval: Melanoma

On September 4, 2014, the FDA granted Keytruda its first approval for the treatment of patients with unresectable or metastatic melanoma, a type of skin cancer. This approval marked a significant milestone in the development of immunotherapy treatments.

****"The FDA's approval of Keytruda for melanoma represents a major breakthrough in the treatment of this aggressive and often deadly disease,"** said Dr. Richard Pazdur, Director of the FDA's Office of Hematology and Oncology Products."This approval demonstrates the power of immunotherapy in treating cancer and offers new hope to patients with melanoma." [1]

Subsequent FDA Approvals

Since its initial approval, Keytruda has received numerous FDA approvals for the treatment of various types of cancer, including:

* Classical Hodgkin lymphoma (2017)
* Non-small cell lung cancer (2015)
* Head and neck squamous cell carcinoma (2016)
* Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors (2017)
* Recurrent or metastatic cervical cancer (2018)
* Esophageal squamous cell carcinoma (2019)

Keytruda's Impact on Cancer Treatment

Keytruda's FDA approvals have had a significant impact on cancer treatment. The medication has been shown to improve overall survival rates, response rates, and quality of life for patients with various types of cancer.

****"Keytruda has revolutionized the way we treat cancer,"** said Dr. Roy Herbst, Chief of Medical Oncology at Yale Cancer Center."It's a game-changer in the field of oncology, and we're seeing remarkable responses in patients with a range of cancer types." [2]

Conclusion

Keytruda's first FDA approval was granted on September 4, 2014, for the treatment of patients with unresectable or metastatic melanoma. Since then, the medication has received numerous FDA approvals for the treatment of various types of cancer. Keytruda's impact on cancer treatment has been significant, offering new hope to patients with aggressive and often deadly diseases.

Key Takeaways

* Keytruda was first approved by the FDA on September 4, 2014, for the treatment of patients with unresectable or metastatic melanoma.
* The medication has received numerous FDA approvals for the treatment of various types of cancer.
* Keytruda has been shown to improve overall survival rates, response rates, and quality of life for patients with various types of cancer.

FAQs

1. What is Keytruda?
Keytruda is a programmed death receptor-1 (PD-1) inhibitor used to treat various types of cancer.
2. What was Keytruda's first FDA approval granted for?
Keytruda's first FDA approval was granted for the treatment of patients with unresectable or metastatic melanoma.
3. How many FDA approvals has Keytruda received?
Keytruda has received numerous FDA approvals for the treatment of various types of cancer.
4. What is the impact of Keytruda on cancer treatment?
Keytruda has been shown to improve overall survival rates, response rates, and quality of life for patients with various types of cancer.
5. What is the future of Keytruda in cancer treatment?
Keytruda is expected to continue playing a significant role in cancer treatment, with ongoing clinical trials and potential future approvals for additional cancer types.

References

[1] FDA. (2014, September 4). FDA Approves Merck's Keytruda (pembrolizumab) for Advanced Melanoma.

[2] Herbst, R. S. (2019, March 14). Keytruda: A Game-Changer in Cancer Treatment. Retrieved from <https://www.drugpatentwatch.com/blog/keytruda-a-game-changer-in-cancer-treatment/>

Cited Sources

1. FDA. (2014, September 4). FDA Approves Merck's Keytruda (pembrolizumab) for Advanced Melanoma.
2. Herbst, R. S. (2019, March 14). Keytruda: A Game-Changer in Cancer Treatment. Retrieved from <https://www.drugpatentwatch.com/blog/keytruda-a-game-changer-in-cancer-treatment/>