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When Did Keytruda Gain Initial FDA Approval?

A Breakthrough in Cancer Treatment: The Story of Keytruda's FDA Approval

The FDA's approval of Keytruda, also known as pembrolizumab, marked a significant milestone in the fight against cancer. But when did this groundbreaking immunotherapy gain its initial FDA approval?

The Journey to FDA Approval

Pembrolizumab, marketed as Keytruda by Merck & Co., Inc., is a humanized monoclonal antibody that targets the PD-1 receptor on T-cells. This receptor plays a crucial role in regulating the immune response, and its inhibition allows the immune system to recognize and attack cancer cells more effectively.

Early Clinical Trials

The development of Keytruda began in the early 2000s, with the first clinical trials conducted in 2008. These initial studies focused on the treatment of advanced melanoma, a type of skin cancer.

FDA Approval: A Turning Point

After years of rigorous testing and evaluation, Keytruda gained its initial FDA approval on September 4, 2014. The approval was based on the results of a Phase III clinical trial, known as KEYNOTE-001, which demonstrated Keytruda's efficacy in treating advanced melanoma.

A Breakthrough in Melanoma Treatment

The FDA approval of Keytruda marked a significant breakthrough in the treatment of melanoma. Prior to its approval, the five-year survival rate for patients with advanced melanoma was around 5%. With Keytruda, this rate increased to around 30%.

Expanded Indications

Since its initial approval, Keytruda has gained expanded indications for the treatment of various types of cancer, including:

* Non-small cell lung cancer (NSCLC): Keytruda received FDA approval for the treatment of NSCLC in 2015.
* Classical Hodgkin lymphoma (cHL): Keytruda gained FDA approval for the treatment of cHL in 2017.
* Head and neck squamous cell carcinoma (HNSCC): Keytruda received FDA approval for the treatment of HNSCC in 2016.

The Future of Cancer Treatment

The FDA approval of Keytruda has paved the way for the development of other immunotherapies. As researchers continue to explore the potential of these treatments, we can expect to see even more breakthroughs in the fight against cancer.

Key Takeaways

* Keytruda gained its initial FDA approval on September 4, 2014.
* The approval was based on the results of a Phase III clinical trial, KEYNOTE-001.
* Keytruda has gained expanded indications for the treatment of various types of cancer, including NSCLC, cHL, and HNSCC.

Frequently Asked Questions

Q: What is Keytruda?
A: Keytruda is a humanized monoclonal antibody that targets the PD-1 receptor on T-cells.

Q: What type of cancer was Keytruda initially approved for?
A: Keytruda was initially approved for the treatment of advanced melanoma.

Q: What is the five-year survival rate for patients with advanced melanoma treated with Keytruda?
A: The five-year survival rate for patients with advanced melanoma treated with Keytruda is around 30%.

Q: Has Keytruda gained expanded indications for the treatment of other types of cancer?
A: Yes, Keytruda has gained expanded indications for the treatment of NSCLC, cHL, and HNSCC.

Q: What is the future of cancer treatment with immunotherapies like Keytruda?
A: The FDA approval of Keytruda has paved the way for the development of other immunotherapies, and researchers continue to explore the potential of these treatments to combat cancer.

Sources

1. Merck & Co., Inc. (2014). Keytruda (pembrolizumab) approved by FDA for advanced melanoma. Retrieved from <https://www.merck.com/news/keytruda-pembrolizumab-approved-by-fda-for-advanced-melanoma/>
2. DrugPatentWatch.com. (n.d.). Pembrolizumab (Keytruda). Retrieved from <https://www.drugpatentwatch.com/patent/US-8808944>
3. FDA. (2014). FDA approves Keytruda to treat advanced melanoma. Retrieved from <https://www.fda.gov/news-events/press-announcements/fda-approves-keytruda-treat-advanced-melanoma>

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