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When Did Keytruda First Receive FDA Approval for Cancer Treatment?

Introduction

Cancer is a devastating disease that affects millions of people worldwide. In recent years, advancements in cancer treatment have led to the development of innovative therapies that have improved patient outcomes. One such therapy is Keytruda, a medication developed by Merck & Co. that has revolutionized the treatment of various types of cancer. In this article, we will explore the history of Keytruda's FDA approval and its impact on cancer treatment.

Early Development

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

FDA Approval

Keytruda first received FDA approval on September 4, 2014, for the treatment of patients with unresectable or metastatic melanoma who have progressed after prior treatment. This approval marked a significant milestone in the development of immunotherapy for cancer treatment.

Expansion of Indications

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

* Classical Hodgkin lymphoma: Keytruda received FDA approval in 2017 for the treatment of adult patients with classical Hodgkin lymphoma who have relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin.
* Non-small cell lung cancer: Keytruda received FDA approval in 2015 for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) who have progressed after platinum-containing chemotherapy.
* Head and neck squamous cell carcinoma: Keytruda received FDA approval in 2016 for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who have progressed after platinum-containing chemotherapy.
* Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors: Keytruda received FDA approval in 2017 for the treatment of patients with MSI-H or dMMR solid tumors that have progressed after prior treatment.

Impact on Cancer Treatment

Keytruda's FDA approvals have had a significant impact on cancer treatment. The medication has been shown to improve patient outcomes, including overall survival, response rates, and quality of life.

Industry Expert Insights

"We are thrilled to see the progress that Keytruda has made in the treatment of various types of cancer," said Dr. Roy Baynes, Senior Vice President and Head of Global Clinical Development, Merck Research Laboratories. "Keytruda's ability to target the PD-1 protein has opened up new avenues for cancer treatment, and we are committed to continuing to explore its potential in various settings."

Conclusion

Keytruda's FDA approval in 2014 marked a significant milestone in the development of immunotherapy for cancer treatment. Since then, the medication has received additional approvals for the treatment of various types of cancer, including melanoma, classical Hodgkin lymphoma, non-small cell lung cancer, head and neck squamous cell carcinoma, and microsatellite instability-high or mismatch repair deficient solid tumors. Keytruda's impact on cancer treatment has been significant, and its continued development holds promise for improving patient outcomes.

Key Takeaways

* Keytruda received FDA approval in 2014 for the treatment of patients with unresectable or metastatic melanoma who have progressed after prior treatment.
* Keytruda has received additional FDA approvals for the treatment of various types of cancer, including classical Hodgkin lymphoma, non-small cell lung cancer, head and neck squamous cell carcinoma, and microsatellite instability-high or mismatch repair deficient solid tumors.
* Keytruda has been shown to improve patient outcomes, including overall survival, response rates, and quality of life.

FAQs

1. What is Keytruda?
Keytruda is a medication developed by Merck & Co. that targets the PD-1 protein on immune cells to enable the immune system to recognize and attack cancer cells more effectively.

2. What is the mechanism of action of Keytruda?
Keytruda works by blocking the PD-1 protein on immune cells, allowing the immune system to recognize and attack cancer cells more effectively.

3. What types of cancer has Keytruda received FDA approval for?
Keytruda has received FDA approval for the treatment of various types of cancer, including melanoma, classical Hodgkin lymphoma, non-small cell lung cancer, head and neck squamous cell carcinoma, and microsatellite instability-high or mismatch repair deficient solid tumors.

4. What are the benefits of Keytruda treatment?
Keytruda treatment has been shown to improve patient outcomes, including overall survival, response rates, and quality of life.

5. Is Keytruda a new treatment option for cancer?
Yes, Keytruda is a new treatment option for cancer that has revolutionized the treatment of various types of cancer.

Sources

1. Merck & Co. (2014). FDA Approves KEYTRUDA (pembrolizumab) for the Treatment of Patients with Unresectable or Metastatic Melanoma Who Have Progressed After Prior Treatment. Retrieved from <https://www.merck.com/news/fda-approves-keytruda-pembrolizumab-for-the-treatment-of-patients-with-unresectable-or-metastatic-melanoma-who-have-progressed-after-prior-treatment/>

2. DrugPatentWatch.com. (n.d.). Pembrolizumab (KEYTRUDA) Patent Expiration. Retrieved from <https://www.drugpatentwatch.com/patent-expiration/pembrolizumab-keytruda>

3. National Cancer Institute. (n.d.). Pembrolizumab. Retrieved from <https://www.cancer.gov/about-cancer/treatment/types/immunotherapy/pembrolizumab>

4. Merck & Co. (2017). KEYTRUDA (pembrolizumab) Receives FDA Approval for the Treatment of Classical Hodgkin Lymphoma. Retrieved from <https://www.merck.com/news/keytruda-pembrolizumab-receives-fda-approval-for-the-treatment-of-classical-hodgkin-lymphoma/>

5. American Cancer Society. (n.d.). Pembrolizumab (Keytruda). Retrieved from <https://www.cancer.org/treatment/treatments-and-side-effects/treatment-types/immunotherapy/pembrolizumab.html>