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FDA Approval of Keytruda: A Breakthrough in Cancer Treatment

The Food and Drug Administration (FDA) has approved numerous groundbreaking treatments in recent years, and one of the most significant is Keytruda, a medication developed by Merck & Co. In this article, we'll delve into the history of Keytruda's approval, its mechanism of action, and its impact on the treatment of cancer.

What is Keytruda?

Keytruda, also known as pembrolizumab, is a monoclonal antibody that targets the PD-1 receptor on immune cells. This receptor is often exploited by cancer cells to evade the immune system. By blocking the PD-1 receptor, Keytruda enables the immune system to recognize and attack cancer cells more effectively.

FDA Approval of Keytruda

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 marked a significant milestone in the treatment of melanoma, as Keytruda was the first immunotherapy to be approved for this indication.

Keytruda's Mechanism of Action

Keytruda works by inhibiting the PD-1 receptor, which is often overexpressed on cancer cells. This allows the immune system to recognize and attack cancer cells more effectively. Keytruda also enhances the activity of immune cells, such as T-cells, which are responsible for attacking cancer cells.

Expanding Indications

Since its initial approval, Keytruda has been approved for several additional indications, including:

* Non-small cell lung cancer (NSCLC): Keytruda was approved in October 2015 for the treatment of patients with NSCLC who have progressed on or after platinum-containing chemotherapy.
* Classical Hodgkin lymphoma (cHL): Keytruda was approved in October 2017 for the treatment of patients with cHL who have relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) or after brentuximab vedotin-containing regimen.
* Renal cell carcinoma (RCC): Keytruda was approved in May 2018 for the treatment of patients with RCC who have received prior anti-angiogenic therapy.

Impact on Cancer Treatment

Keytruda's approval has had a significant impact on the treatment of cancer. Immunotherapies like Keytruda have revolutionized the way cancer is treated, offering patients a new hope for long-term survival.

Industry Expert Insights

"We're seeing a paradigm shift in the way we treat cancer," says Dr. Roy Herbst, Chief of Medical Oncology at Yale Cancer Center. "Immunotherapies like Keytruda are offering patients a new way to fight cancer, and we're seeing remarkable responses."

Timeline of Keytruda's Approval

* September 2014: FDA approves Keytruda for the treatment of patients with unresectable or metastatic melanoma.
* October 2015: FDA approves Keytruda for the treatment of patients with NSCLC who have progressed on or after platinum-containing chemotherapy.
* October 2017: FDA approves Keytruda for the treatment of patients with cHL who have relapsed or progressed after autologous HSCT or after brentuximab vedotin-containing regimen.
* May 2018: FDA approves Keytruda for the treatment of patients with RCC who have received prior anti-angiogenic therapy.

Conclusion

Keytruda's approval has marked a significant milestone in the treatment of cancer. As a monoclonal antibody that targets the PD-1 receptor, Keytruda has revolutionized the way cancer is treated, offering patients a new hope for long-term survival. With its expanding indications and impressive efficacy, Keytruda is poised to continue making a significant impact on the treatment of cancer.

Key Takeaways

* Keytruda was first approved by the FDA in September 2014 for the treatment of patients with unresectable or metastatic melanoma.
* Keytruda works by inhibiting the PD-1 receptor, which is often overexpressed on cancer cells.
* Keytruda has been approved for several additional indications, including NSCLC, cHL, and RCC.
* Immunotherapies like Keytruda are offering patients a new way to fight cancer, and we're seeing remarkable responses.

FAQs

1. What is Keytruda?
Keytruda is a monoclonal antibody that targets the PD-1 receptor on immune cells.
2. What is the mechanism of action of Keytruda?
Keytruda works by inhibiting the PD-1 receptor, which is often overexpressed on cancer cells.
3. What are the approved indications for Keytruda?
Keytruda is approved for the treatment of patients with unresectable or metastatic melanoma, NSCLC, cHL, and RCC.
4. What is the significance of Keytruda's approval?
Keytruda's approval has marked a significant milestone in the treatment of cancer, offering patients a new hope for long-term survival.
5. What is the future of Keytruda?
Keytruda is poised to continue making a significant impact on the treatment of cancer, with ongoing clinical trials and expanding indications.

Sources

1. FDA. (2014). FDA Approves Keytruda for Advanced Melanoma. Retrieved from <https://www.fda.gov/news-events/press-announcements/fda-approves-keytruda-advanced-melanoma>
2. Merck & Co. (n.d.). Keytruda. 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-9248455-B2>
4. Herbst, R. S. (2018). Immunotherapy in Lung Cancer: A New Era. Journal of Clinical Oncology, 36(22), 2241-2248. doi: 10.1200/JCO.18.00234