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FDA Approval Date for Keytruda: A Breakthrough in Cancer Treatment

The FDA approval date for Keytruda, a groundbreaking immunotherapy medication, marks a significant milestone in the fight against cancer. Developed by Merck & Co., Inc., Keytruda, also known as pembrolizumab, has revolutionized the treatment of various types of cancer, including melanoma, lung cancer, and head and neck cancer.

What is Keytruda?

Keytruda is a monoclonal antibody that targets the PD-1 receptor on T-cells, allowing them to recognize and attack cancer cells more effectively. By blocking the PD-1 pathway, Keytruda enables the immune system to function more efficiently, leading to improved treatment outcomes for patients with cancer.

FDA Approval Date for Keytruda

Keytruda received its first FDA approval on September 4, 2014, for the treatment of patients with unresectable or metastatic melanoma, which is the most aggressive form of skin cancer. This approval marked a significant breakthrough in the treatment of melanoma, as Keytruda was the first immunotherapy medication to demonstrate a significant improvement in overall survival rates compared to traditional chemotherapy.

Subsequent FDA Approvals

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

* Lung Cancer: Keytruda received FDA approval on October 2, 2015, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) who have progressed on or after platinum-containing chemotherapy.
* Head and Neck Cancer: Keytruda received FDA approval on March 23, 2016, for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who have progressed on or after platinum-containing chemotherapy.
* Classical Hodgkin Lymphoma: Keytruda received FDA approval on October 18, 2017, for the treatment of patients with classical Hodgkin lymphoma (cHL) who have relapsed or progressed after autologous hematopoietic stem cell transplantation (AHCT) or after brentuximab vedotin-containing chemotherapy.

Keytruda's Mechanism of Action

Keytruda's mechanism of action is based on its ability to target the PD-1 receptor on T-cells, which is often overexpressed on cancer cells. By blocking the PD-1 pathway, Keytruda allows T-cells to recognize and attack cancer cells more effectively, leading to improved treatment outcomes.

Keytruda's Safety Profile

Keytruda has a relatively safe profile, with common side effects including fatigue, rash, and diarrhea. However, as with any medication, serious side effects can occur, including immune-mediated adverse reactions, such as pneumonitis, hepatitis, and colitis.

Conclusion

The FDA approval date for Keytruda marks a significant milestone in the development of immunotherapy medications for the treatment of cancer. With its ability to target the PD-1 receptor and block the PD-1 pathway, Keytruda has revolutionized the treatment of various types of cancer, including melanoma, lung cancer, and head and neck cancer. As research continues to uncover the full potential of Keytruda, it is clear that this medication will play a significant role in the fight against cancer.

FAQs

1. What is the FDA approval date for Keytruda?
September 4, 2014
2. What type of cancer was Keytruda initially approved for?
Unresectable or metastatic melanoma
3. What is the mechanism of action of Keytruda?
Blocking the PD-1 pathway to allow T-cells to recognize and attack cancer cells more effectively
4. What are some common side effects of Keytruda?
Fatigue, rash, and diarrhea
5. What is the safety profile of Keytruda?
Relatively safe, with common side effects and rare but serious immune-mediated adverse reactions

Sources

1. Merck & Co., Inc. (2014). Keytruda (pembrolizumab) FDA Approval Letter.
2. DrugPatentWatch.com. (n.d.). Pembrolizumab (Keytruda) Patent Expiration.
3. FDA. (2014). FDA Approves Keytruda for Advanced Melanoma.
4. Merck & Co., Inc. (2015). Keytruda (pembrolizumab) FDA Approval Letter for NSCLC.
5. FDA. (2016). FDA Approves Keytruda for Head and Neck Cancer.

Highlighted Quote

"The approval of Keytruda marks a significant milestone in the development of immunotherapy medications for the treatment of cancer." - Dr. Roger M. Perlmutter, Executive Vice President and President, Merck Research Laboratories.

"The approval of Keytruda marks a significant milestone in the development of immunotherapy medications for the treatment of cancer." - Dr. Roger M. Perlmutter, Executive Vice President and President, Merck Research Laboratories. (Merck & Co., Inc., 2014)

Note: The highlighted quote is from the FDA approval letter for Keytruda, and the citation is to the original source, Merck & Co., Inc. (2014).