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FDA Approval of Keytruda: A Game-Changer in Cancer Treatment

The approval of Keytruda (pembrolizumab) by the US Food and Drug Administration (FDA) in 2014 marked a significant milestone in the treatment of various types of cancer. Developed by Merck & Co., Inc., Keytruda is a programmed death receptor-1 (PD-1) inhibitor that has revolutionized the way cancer is treated.

What is Keytruda?

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

FDA Approval Timeline

Keytruda was first approved by the FDA in September 2014 for the treatment of patients with unresectable or metastatic melanoma, a type of skin cancer. This approval was based on the results of the KEYNOTE-001 trial, which demonstrated a significant improvement in overall response rate (ORR) and overall survival (OS) compared to chemotherapy.

Expanded Indications

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

* Non-small cell lung cancer (NSCLC): Keytruda was approved in October 2015 for the treatment of patients with advanced NSCLC who have progressed on or after platinum-containing chemotherapy.
* Classical Hodgkin lymphoma: Keytruda was approved in October 2017 for the treatment of patients with classical Hodgkin lymphoma who have relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) or three or more lines of systemic therapy.
* Urothelial carcinoma: Keytruda was approved in May 2017 for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or after platinum-containing chemotherapy.

Keytruda's Mechanism of Action

Keytruda's mechanism of action is based on the concept of immune checkpoint inhibition. Immune checkpoints are molecules that regulate the activity of immune cells, such as T-cells, to prevent them from attacking healthy tissues. Cancer cells can exploit these checkpoints to evade the immune system. Keytruda blocks the PD-1 receptor, allowing T-cells to recognize and attack cancer cells more effectively.

Clinical Trials and Results

Keytruda has been studied in numerous clinical trials, including the KEYNOTE-001, KEYNOTE-006, and KEYNOTE-189 trials. These trials have demonstrated significant improvements in ORR, OS, and progression-free survival (PFS) compared to chemotherapy and other treatments.

Industry Expert Insights

"We believe that Keytruda has the potential to be a game-changer in the treatment of various types of cancer," said Dr. Roy Baynes, Senior Vice President and Head of Global Clinical Development, Merck Research Laboratories. "The results of our clinical trials have shown that Keytruda can provide significant improvements in treatment outcomes for patients with advanced cancer."

Conclusion

The FDA approval of Keytruda in 2014 marked a significant milestone in the treatment of cancer. With its expanded indications and proven efficacy in various types of cancer, Keytruda has become a standard of care in the treatment of advanced cancer. As researchers continue to explore the potential of Keytruda and other immunotherapies, we can expect to see even more innovative treatments emerge in the future.

Key Takeaways

* Keytruda was approved by the FDA in 2014 for the treatment of patients with unresectable or metastatic melanoma.
* Keytruda has received expanded indications for the treatment of various types of cancer, including NSCLC, classical Hodgkin lymphoma, and urothelial carcinoma.
* Keytruda's mechanism of action is based on immune checkpoint inhibition, which allows T-cells to recognize and attack cancer cells more effectively.
* Clinical trials have demonstrated significant improvements in ORR, OS, and PFS compared to chemotherapy and other treatments.

FAQs

1. What is Keytruda?
Keytruda is a programmed death receptor-1 (PD-1) inhibitor that targets the PD-1 receptor on immune cells, allowing them to recognize and attack cancer cells more effectively.
2. What types of cancer is Keytruda approved for?
Keytruda is approved for the treatment of patients with unresectable or metastatic melanoma, non-small cell lung cancer, classical Hodgkin lymphoma, and urothelial carcinoma.
3. How does Keytruda work?
Keytruda works by blocking the PD-1 receptor, allowing T-cells to recognize and attack cancer cells more effectively.
4. What are the benefits of Keytruda?
The benefits of Keytruda include improved overall response rate, overall survival, and progression-free survival compared to chemotherapy and other treatments.
5. Is Keytruda a standard of care in the treatment of advanced cancer?
Yes, Keytruda has become a standard of care in the treatment of advanced cancer, with its expanded indications and proven efficacy in various types of cancer.

Sources

1. FDA. (2014). FDA Approves Merck's Keytruda (pembrolizumab) for Certain Patients with Unresectable or Metastatic Melanoma. Retrieved from <https://www.fda.gov/news-events/press-announcements/fda-approves-mercks-keytruda-pembrolizumab-certain-patients-unresectable-or-metastatic-melanoma>
2. Merck & Co., Inc. (n.d.). Keytruda (pembrolizumab). Retrieved from <https://www.merck.com/product/usa/picirculars/k/keytruda/keytrudapi.pdf>
3. DrugPatentWatch.com. (n.d.). Pembrolizumab (Keytruda). Retrieved from <https://www.drugpatentwatch.com/patent/US-9248444>
4. Baynes, R. (2018). Pembrolizumab (Keytruda) for the treatment of advanced melanoma. Retrieved from <https://www.merck.com/clinical-trials/pembrolizumab-keytruda-advanced-melanoma>
5. National Cancer Institute. (n.d.). Pembrolizumab. Retrieved from <https://www.cancer.gov/about-cancer/treatment/types/immunotherapy/pembrolizumab-fact-sheet>