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FDA Approval Date for Keytruda in Cancer Treatment: A Breakthrough in Immunotherapy

The FDA approval date for Keytruda, a groundbreaking immunotherapy drug, marks a significant milestone in the treatment of various types of cancer. Developed by Merck & Co., Inc., Keytruda (pembrolizumab) has revolutionized the way cancer is treated, offering new hope to patients and their families.

What is Keytruda?

Keytruda is a programmed death receptor-1 (PD-1) inhibitor, a type of immunotherapy that works by enhancing the body's natural defense against cancer cells. By blocking the PD-1 pathway, Keytruda allows the immune system to recognize and attack cancer cells more effectively.

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, a type of skin cancer. This approval marked a significant breakthrough in the treatment of melanoma, offering patients a new option with improved response rates and overall survival compared to traditional therapies.

Subsequent FDA Approvals

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

* Head and Neck Squamous Cell Carcinoma (HNSCC): FDA approval on December 20, 2016, for patients with recurrent or metastatic HNSCC who have progressed on or are intolerant to platinum-containing chemotherapy.
* Classical Hodgkin Lymphoma (cHL): FDA approval on October 18, 2017, for patients with refractory cHL who have progressed on or after autologous hematopoietic stem cell transplantation (HSCT) or have relapsed after two or more prior lines of therapy.
* Non-Small Cell Lung Cancer (NSCLC): FDA approval on October 18, 2015, for patients with metastatic NSCLC who have progressed on or after platinum-containing chemotherapy.
* Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer: FDA approval on March 23, 2017, for patients with MSI-H or dMMR metastatic colorectal cancer who have progressed on or are intolerant to prior therapy.

Keytruda's Mechanism of Action

Keytruda's mechanism of action is based on the concept of immune checkpoint inhibition. Cancer cells often evade the immune system by expressing PD-L1, a protein that binds to PD-1 on immune cells, preventing them from attacking the cancer cells. Keytruda blocks this interaction, allowing the immune system to recognize and attack cancer cells more effectively.

Clinical Trials and Results

Keytruda has been studied in numerous clinical trials, with impressive results. In a phase III clinical trial, Keytruda demonstrated a significant improvement in overall survival compared to chemotherapy in patients with advanced NSCLC. Another phase III trial showed that Keytruda improved overall survival and response rates compared to chemotherapy in patients with advanced HNSCC.

Conclusion

The FDA approval date for Keytruda in cancer treatment marks a significant milestone in the development of immunotherapy. With its mechanism of action based on immune checkpoint inhibition, Keytruda has revolutionized the way cancer is treated, offering new hope to patients and their families. As research continues to uncover the full potential of Keytruda, it is clear that this drug will play a crucial role in the fight against cancer.

FAQs

1. What is the FDA approval date for Keytruda in cancer treatment?
* 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?
* Immune checkpoint inhibition
4. How many FDA approvals has Keytruda received?
* 5 (melanoma, HNSCC, cHL, NSCLC, and MSI-H or dMMR colorectal cancer)
5. What is the primary goal of Keytruda in cancer treatment?
* To enhance the body's natural defense against cancer cells

Sources:

1. DrugPatentWatch.com. (n.d.). Pembrolizumab (Keytruda) Patent Expiration. Retrieved from <https://www.drugpatentwatch.com/patent-expiration-date/pembrolizumab-keytruda>
2. Merck & Co., Inc. (n.d.). Keytruda (pembrolizumab) Prescribing Information. Retrieved from <https://www.merck.com/product/usa/picirculars/k/keytruda/keytrudapi.pdf>
3. FDA. (2014, September 4). FDA Approves Keytruda (pembrolizumab) for Advanced Melanoma. Retrieved from <https://www.fda.gov/news-events/press-announcements/fda-approves-keytruda-pembrolizumab-advanced-melanoma>
4.

“The FDA approval of Keytruda marks a significant milestone in the development of immunotherapy for cancer treatment.” — Dr. Richard Pazdur, Director, FDA's Office of Hematology and Oncology Products