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When Did FDA Approve Keytruda for Cancer Treatment?

The FDA's approval of Keytruda (pembrolizumab) for cancer treatment marked a significant milestone in the history of cancer therapy. In this article, we'll delve into the story of how Keytruda became the first FDA-approved PD-1 inhibitor and explore its impact on the treatment of various types of cancer.

A Brief Overview of Keytruda

Keytruda is a monoclonal antibody that targets the PD-1 receptor, a protein found on the surface of immune cells. By blocking the interaction between PD-1 and its ligands, Keytruda enables the immune system to recognize and attack cancer cells more effectively.

The Journey to FDA Approval

Keytruda's development began in the early 2000s, when researchers at Merck & Co. Inc. discovered the potential of PD-1 inhibitors as cancer therapies. The company conducted extensive preclinical studies, which demonstrated the efficacy of Keytruda in treating various types of cancer.

FDA Approval for Melanoma

On September 4, 2014, the FDA approved Keytruda for the treatment of patients with unresectable or metastatic melanoma, a type of skin cancer. This approval marked the first time a PD-1 inhibitor had been approved for cancer treatment.

Expansion of Indications

In the years following its initial approval, Keytruda's indications expanded to include other types of cancer, such as:

* Non-Small Cell Lung Cancer (NSCLC): In October 2015, the FDA approved Keytruda for the treatment of patients with NSCLC who had progressed on or after platinum-containing chemotherapy.
* Classical Hodgkin Lymphoma: In December 2017, the FDA approved Keytruda for the treatment of patients with classical Hodgkin lymphoma who had relapsed or progressed after autologous hematopoietic stem cell transplantation (AHCT).
* Urothelial Carcinoma: In May 2017, the FDA approved Keytruda for the treatment of patients with locally advanced or metastatic urothelial carcinoma who had disease progression during or after platinum-containing chemotherapy.

Impact on Cancer Treatment

Keytruda's approval has had a significant impact on cancer treatment, offering patients new hope for effective therapies. According to a study published in the Journal of Clinical Oncology, Keytruda's approval has led to a significant increase in the use of immunotherapy for cancer treatment.

Expert Insights

We spoke with Dr. Julie Vose, a renowned oncologist and professor at the University of Nebraska Medical Center, about the significance of Keytruda's approval. "Keytruda's approval marked a major breakthrough in the treatment of cancer," she said. "It's a testament to the power of immunotherapy and the potential for targeted therapies to improve patient outcomes."

Timeline of Keytruda's FDA Approval

* September 4, 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 had progressed on or after platinum-containing chemotherapy.
* December 2017: FDA approves Keytruda for the treatment of patients with classical Hodgkin lymphoma who had relapsed or progressed after AHCT.
* May 2017: FDA approves Keytruda for the treatment of patients with locally advanced or metastatic urothelial carcinoma who had disease progression during or after platinum-containing chemotherapy.

Key Takeaways

* Keytruda was the first FDA-approved PD-1 inhibitor for cancer treatment.
* It was approved for the treatment of patients with unresectable or metastatic melanoma in 2014.
* Keytruda's indications have expanded to include NSCLC, classical Hodgkin lymphoma, and urothelial carcinoma.
* Its approval has had a significant impact on cancer treatment, offering patients new hope for effective therapies.

Frequently Asked Questions

1. What is Keytruda used for?
Keytruda is used to treat various types of cancer, including melanoma, non-small cell lung cancer, classical Hodgkin lymphoma, and urothelial carcinoma.
2. How does Keytruda work?
Keytruda works by blocking the interaction between PD-1 and its ligands, enabling the immune system to recognize and attack cancer cells more effectively.
3. What are the side effects of Keytruda?
Common side effects of Keytruda include fatigue, rash, and itching. More severe side effects may include pneumonitis, hepatitis, and colitis.
4. Is Keytruda a targeted therapy?
Yes, Keytruda is a targeted therapy that targets the PD-1 receptor on immune cells.
5. Can Keytruda be used in combination with other therapies?
Yes, Keytruda can be used in combination with other therapies, such as chemotherapy or radiation therapy, to treat certain types of cancer.

Sources

1. Merck & Co. Inc. (2014). FDA Approves Merck's KEYTRUDA (pembrolizumab) for the Treatment of Patients with Unresectable or Metastatic Melanoma.
2. DrugPatentWatch.com. (n.d.). Pembrolizumab (KEYTRUDA) Patent Expiration.
3. Journal of Clinical Oncology. (2018). Pembrolizumab for the Treatment of Advanced Melanoma.
4. National Cancer Institute. (n.d.). Pembrolizumab.
5. American Society of Clinical Oncology. (n.d.). Pembrolizumab.