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When Did Keytruda Gain FDA Approval for Use in Cancer Therapy?

Introduction

Cancer is a devastating disease that affects millions of people worldwide. The treatment options for cancer have evolved significantly over the years, and immunotherapy has emerged as a promising approach. One of the most widely used immunotherapies is Keytruda, a medication developed by Merck & Co. In this article, we will explore the journey of Keytruda's approval by the US Food and Drug Administration (FDA) for use in cancer therapy.

Early Development and Clinical Trials

Keytruda, also known as pembrolizumab, is a humanized monoclonal antibody that targets the PD-1 receptor. The development of Keytruda began in the early 2000s, with the first clinical trials commencing in 2008. The initial studies focused on the treatment of advanced melanoma, a type of skin cancer.

FDA Approval for Melanoma

On September 4, 2014, the FDA granted accelerated approval to Keytruda for the treatment of patients with unresectable or metastatic melanoma who had progressed after prior therapy. This marked a significant milestone in the development of immunotherapy for cancer treatment.

Expansion of Indications

Building on the success of Keytruda in melanoma, Merck & Co. conducted clinical trials to evaluate its efficacy in other types of cancer. In 2015, the FDA approved Keytruda for the treatment of patients with classical Hodgkin lymphoma who had progressed after autologous stem cell transplant and brentuximab vedotin.

Breakthrough Therapy Designation

In 2015, the FDA granted Breakthrough Therapy Designation to Keytruda for the treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors express PD-L1. This designation expedited the development and review process for Keytruda, allowing it to reach patients more quickly.

FDA Approval for NSCLC

On October 2, 2015, the FDA approved Keytruda for the treatment of patients with advanced NSCLC whose tumors express PD-L1 with a combined positive score (CPS) of 1 or higher. This marked the first FDA approval of an immunotherapy for NSCLC.

Widespread Adoption

Since its initial approval, Keytruda has been approved for use in multiple cancer types, including head and neck squamous cell carcinoma, small cell lung cancer, and cervical cancer. Its widespread adoption has led to significant improvements in patient outcomes, including increased overall survival rates and reduced toxicity.

Cost and Access

Despite its life-changing benefits, Keytruda is a costly medication, with a list price of over $12,000 per month. This has raised concerns about access and affordability, particularly for patients with limited financial resources. As a result, Merck & Co. has implemented various programs to reduce the cost of Keytruda, including patient assistance programs and copay assistance programs.

Conclusion

Keytruda's journey to FDA approval has been marked by significant milestones and breakthroughs. From its initial approval for melanoma to its widespread adoption across multiple cancer types, Keytruda has revolutionized the treatment of cancer. As the landscape of cancer therapy continues to evolve, Keytruda remains a vital component of the fight against this devastating disease.

Key Takeaways

* Keytruda was first approved by the FDA in 2014 for the treatment of patients with unresectable or metastatic melanoma.
* The FDA granted Breakthrough Therapy Designation to Keytruda for the treatment of patients with advanced NSCLC in 2015.
* Keytruda was approved for the treatment of patients with advanced NSCLC in 2015.
* Keytruda has been approved for use in multiple cancer types, including head and neck squamous cell carcinoma, small cell lung cancer, and cervical cancer.
* Keytruda is a costly medication, with a list price of over $12,000 per month.

FAQs

1. What is Keytruda?
Keytruda is a humanized monoclonal antibody that targets the PD-1 receptor and is used to treat various types of cancer.
2. When was Keytruda first approved by the FDA?
Keytruda was first approved by the FDA in 2014 for the treatment of patients with unresectable or metastatic melanoma.
3. What is the list price of Keytruda?
The list price of Keytruda is over $12,000 per month.
4. What is the Breakthrough Therapy Designation?
The Breakthrough Therapy Designation is a designation granted by the FDA to expedite the development and review process for a medication that has shown significant clinical improvement over existing treatments.
5. What is the CPS score?
The CPS score is a measure of the level of PD-L1 expression in a patient's tumor, with a score of 1 or higher indicating a higher likelihood of response to Keytruda.

Sources

1. Merck & Co. (2014). FDA Approves Keytruda (pembrolizumab) for Patients with Unresectable or Metastatic Melanoma. Retrieved from <https://www.merck.com/news/fda-approves-keytruda-pembrolizumab-for-patients-with-unresectable-or-metastatic-melanoma/>
2. DrugPatentWatch.com. (n.d.). Pembrolizumab (Keytruda) Patent Expiration. Retrieved from <https://www.drugpatentwatch.com/patent/US-9315341>
3. FDA (2014). FDA Approves Keytruda (pembrolizumab) for Patients with Unresectable or Metastatic Melanoma. Retrieved from <https://www.fda.gov/news-events/press-announcements/fda-approves-keytruda-pembrolizumab-patients-unresectable-or-metastatic-melanoma>
4. Merck & Co. (2015). FDA Grants Breakthrough Therapy Designation to Keytruda (pembrolizumab) for Advanced Non-Small Cell Lung Cancer. Retrieved from <https://www.merck.com/news/fda-grants-breakthrough-therapy-designation-to-keytruda-pembrolizumab-for-advanced-non-small-cell-lung-cancer/>
5. FDA (2015). FDA Approves Keytruda (pembrolizumab) for Patients with Advanced Non-Small Cell Lung Cancer. Retrieved from <https://www.fda.gov/news-events/press-announcements/fda-approves-keytruda-pembrolizumab-patients-advanced-non-small-cell-lung-cancer>