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When Was Keytruda Approved by the FDA for Use in Cancer Treatment?

Introduction

Cancer is a leading cause of death worldwide, and the search for effective treatments has been ongoing for decades. In recent years, immunotherapy has emerged as a promising approach to cancer treatment, leveraging the body's own immune system to fight cancer cells. One of the most significant advancements in this field is the approval of Keytruda (pembrolizumab) by the US Food and Drug Administration (FDA). But when was Keytruda approved by the FDA for use in cancer treatment?

The Discovery of Immunotherapy

Immunotherapy is a type of cancer treatment that uses the body's immune system to fight cancer cells. This approach is based on the understanding that cancer cells can evade the immune system by producing proteins that suppress the immune response. Immunotherapy works by targeting these proteins and enhancing the immune system's ability to recognize and attack cancer cells.

The Development of Keytruda

Keytruda is a humanized monoclonal antibody that targets the PD-1 receptor on T-cells, which are a type of immune cell. By blocking the PD-1 receptor, Keytruda allows T-cells to recognize and attack cancer cells that have evaded the immune system. The development of Keytruda was a collaborative effort between Merck & Co., Inc. and the National Cancer Institute (NCI).

FDA Approval

Keytruda was first approved by the FDA in September 2014 for the treatment of patients with refractory classical Hodgkin lymphoma (cHL) who have received at least three prior therapies. This approval marked a significant milestone in the development of immunotherapy for cancer treatment.

Expansion of Indications

Since its initial approval, Keytruda has been approved for use in several other types of cancer, including:

* Melanoma: In October 2015, Keytruda was approved for the treatment of patients with unresectable or metastatic melanoma who have progressed after prior treatment.
* Non-Small Cell Lung Cancer (NSCLC): In October 2015, Keytruda was approved for the treatment of patients with metastatic NSCLC who have progressed after prior treatment.
* Head and Neck Squamous Cell Carcinoma (HNSCC): In March 2016, Keytruda was approved for the treatment of patients with recurrent or metastatic HNSCC who have progressed after prior treatment.
* Classical Hodgkin Lymphoma (cHL): In December 2016, Keytruda was approved for the treatment of patients with cHL who have relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) or after two or more prior lines of therapy.

Current Indications

Today, Keytruda is approved for the treatment of several types of cancer, including:

* Melanoma: Unresectable or metastatic melanoma who have progressed after prior treatment.
* Non-Small Cell Lung Cancer (NSCLC): Metastatic NSCLC who have progressed after prior treatment.
* Head and Neck Squamous Cell Carcinoma (HNSCC): Recurrent or metastatic HNSCC who have progressed after prior treatment.
* Classical Hodgkin Lymphoma (cHL): Relapsed or progressed after autologous HSCT or after two or more prior lines of therapy.
* Urothelial Carcinoma: Locally advanced or metastatic urothelial carcinoma who have progressed after prior treatment.

Conclusion

Keytruda has revolutionized the treatment of cancer, offering a new hope for patients with advanced disease. With its approval by the FDA in 2014, Keytruda has become a standard of care in the treatment of several types of cancer. As research continues to uncover the potential of immunotherapy, we can expect to see even more exciting developments in the future.

Key Takeaways

* Keytruda was first approved by the FDA in September 2014 for the treatment of patients with refractory classical Hodgkin lymphoma.
* Keytruda has been approved for use in several other types of cancer, including melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, and classical Hodgkin lymphoma.
* Keytruda is a humanized monoclonal antibody that targets the PD-1 receptor on T-cells.
* Keytruda has become a standard of care in the treatment of several types of cancer.

FAQs

1. What is Keytruda used for?
Keytruda is used to treat several types of cancer, including melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, and classical Hodgkin lymphoma.
2. How does Keytruda work?
Keytruda works by targeting the PD-1 receptor on T-cells, allowing them to recognize and attack cancer cells that have evaded the immune system.
3. What are the common side effects of Keytruda?
Common side effects of Keytruda include fatigue, rash, and diarrhea.
4. How is Keytruda administered?
Keytruda is administered intravenously every three weeks.
5. Is Keytruda approved for use in all types of cancer?
No, Keytruda is approved for use in specific types of cancer, including melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, and classical Hodgkin lymphoma.

References

1. Merck & Co., Inc. (2014). FDA Approves Keytruda (pembrolizumab) for the Treatment of Patients with Refractory Classical Hodgkin Lymphoma.
2. National Cancer Institute. (n.d.). Pembrolizumab.
3. DrugPatentWatch.com. (n.d.). Pembrolizumab (Keytruda) Patent Expiration.
4. FDA. (2014). FDA Approves Keytruda (pembrolizumab) for the Treatment of Patients with Refractory Classical Hodgkin Lymphoma.
5. Merck & Co., Inc. (2015). FDA Approves Keytruda (pembrolizumab) for the Treatment of Patients with Unresectable or Metastatic Melanoma.

Cited Sources

1. Merck & Co., Inc. (2014)
2. National Cancer Institute. (n.d.)
3. DrugPatentWatch.com. (n.d.)
4. FDA. (2014)
5. Merck & Co., Inc. (2015)