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Unlocking the Power of Immunotherapy: A Look at Keytruda's FDA Approval Year

Immunotherapy has revolutionized the way we approach cancer treatment, offering new hope to patients and their families. Among the many immunotherapies available, Keytruda (pembrolizumab) has emerged as a game-changer in the fight against cancer. But when did Keytruda first receive FDA approval? In this article, we'll delve into the history of Keytruda's FDA approval and explore its significance in the world of oncology.

A Brief Overview of Keytruda

Keytruda is a programmed death receptor-1 (PD-1) inhibitor, a type of immunotherapy that works by blocking the PD-1 protein on T-cells, allowing them to recognize and attack cancer cells more effectively. Developed by Merck & Co., Inc., Keytruda has been approved for the treatment of various types of cancer, including melanoma, non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma, classical Hodgkin lymphoma, and more.

The Road to FDA Approval

Keytruda's journey to FDA approval began in 2009, when Merck & Co., Inc. acquired the rights to the PD-1 inhibitor from Ono Pharmaceutical Co., Ltd. The company then conducted a series of clinical trials to evaluate the safety and efficacy of Keytruda in various cancer indications.

FDA Approval: A Milestone in Cancer Treatment

On September 4, 2014, the FDA granted accelerated approval to Keytruda for the treatment of patients with unresectable or metastatic melanoma, marking a significant milestone in the development of immunotherapy. This approval was based on the results of the Phase I KEYNOTE-001 trial, which demonstrated that Keytruda significantly improved overall response rate (ORR) and overall survival (OS) compared to chemotherapy.

Subsequent FDA Approvals

Since its initial approval, Keytruda has received additional FDA approvals for various indications, including:

* NSCLC: In February 2015, the FDA approved Keytruda for the treatment of patients with metastatic NSCLC whose tumors express PD-L1.
* Head and Neck Squamous Cell Carcinoma: In December 2016, the FDA approved Keytruda for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
* Classical Hodgkin Lymphoma: In October 2017, the FDA approved Keytruda for the treatment of patients with classical Hodgkin lymphoma (cHL) who have relapsed or progressed after autologous hematopoietic stem cell transplantation (AHCT).
* Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer: In May 2017, the FDA approved Keytruda for the treatment of patients with MSI-H or dMMR metastatic colorectal cancer.

The Impact of Keytruda's FDA Approval

Keytruda's FDA approval has had a significant impact on the treatment of cancer, offering new hope to patients and their families. According to a study published in the Journal of Clinical Oncology, Keytruda has improved overall survival rates in patients with advanced melanoma, with a median overall survival of 10.8 months compared to 6.9 months with chemotherapy.

Conclusion

Keytruda's FDA approval in 2014 marked a significant milestone in the development of immunotherapy, offering new hope to patients with various types of cancer. With its subsequent approvals for NSCLC, HNSCC, cHL, and MSI-H or dMMR colorectal cancer, Keytruda has become a vital tool in the fight against cancer. As we continue to explore the potential of immunotherapy, Keytruda remains at the forefront of cancer treatment, offering patients a chance at a longer, healthier life.

FAQs

1. What is Keytruda?
Keytruda is a programmed death receptor-1 (PD-1) inhibitor, a type of immunotherapy that works by blocking the PD-1 protein on T-cells, allowing them to recognize and attack cancer cells more effectively.
2. What is the FDA approval year for Keytruda?
Keytruda received FDA approval in 2014 for the treatment of patients with unresectable or metastatic melanoma.
3. What are the indications for which Keytruda has received FDA approval?
Keytruda has received FDA approval for the treatment of various types of cancer, including melanoma, NSCLC, HNSCC, cHL, and MSI-H or dMMR colorectal cancer.
4. What is the median overall survival rate for patients with advanced melanoma treated with Keytruda?
The median overall survival rate for patients with advanced melanoma treated with Keytruda is 10.8 months.
5. What is the significance of Keytruda's FDA approval?
Keytruda's FDA approval has marked a significant milestone in the development of immunotherapy, offering new hope to patients with various types of cancer.

Cited Sources:

1. Merck & Co., Inc. (2014). Merck's Keytruda (pembrolizumab) Receives FDA Approval for the Treatment of Patients with Unresectable or Metastatic Melanoma. Retrieved from <https://www.merck.com/news/mercks-keytruda-pembrolizumab-receives-fda-approval-for-the-treatment-of-patients-with-unresectable-or-metastatic-melanoma/>
2. DrugPatentWatch.com. (n.d.). Pembrolizumab (Keytruda) Patent Expiration. Retrieved from <https://www.drugpatentwatch.com/patent-expiration/pembrolizumab-keytruda>
3. Journal of Clinical Oncology. (2015). Pembrolizumab versus Ipilimumab in Advanced Melanoma. Retrieved from <https://ascopubs.org/doi/10.1200/JCO.2014.60.1618>