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Unlocking the Power of Immunotherapy: The FDA Approval of Keytruda in Cancer Therapy

A Breakthrough in Cancer Treatment: The Story of Keytruda

Cancer, a disease that has plagued humanity for centuries, has been a major focus of medical research in recent years. With the advancement of technology and our understanding of the human body, scientists have been working tirelessly to develop new and innovative treatments to combat this deadly disease. One such breakthrough is the FDA approval of Keytruda, a revolutionary immunotherapy medication that has changed the face of cancer treatment.

What is Keytruda?

Keytruda, also known as pembrolizumab, is a monoclonal antibody that targets the PD-1 protein on the surface of T-cells. This protein is a checkpoint that prevents the immune system from attacking cancer cells. By blocking this checkpoint, Keytruda allows the immune system to recognize and destroy cancer cells, thereby providing a new hope for patients with advanced cancer.

The FDA Approval of Keytruda

Keytruda gained FDA approval in September 2014 for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose disease progressed on or after platinum-based chemotherapy. This approval marked a significant milestone in the history of cancer treatment, as it was the first time an immunotherapy medication had been approved for the treatment of NSCLC.

Expansion of Indications

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

*

Head and Neck Squamous Cell Carcinoma (HNSCC)

: In 2016, the FDA approved Keytruda for the treatment of patients with HNSCC whose disease progressed on or after platinum-based chemotherapy.
*

Classical Hodgkin Lymphoma (cHL)

: In 2017, the FDA approved Keytruda for the treatment of patients with cHL who have failed or are intolerant to brentuximab vedotin.
*

Urothelial Carcinoma (UC)

: In 2017, the FDA approved Keytruda for the treatment of patients with UC who have disease progression during or following platinum-containing chemotherapy.
*

Microsatellite Instability-High (MSI-H) Cancer

: In 2017, the FDA approved Keytruda for the treatment of patients with MSI-H cancer, including colorectal, endometrial, and other types of cancer.
*

Renal Cell Carcinoma (RCC)

: In 2019, the FDA approved Keytruda for the treatment of patients with RCC who have disease progression during or following prior anti-angiogenic therapy.

Why is Keytruda a Game-Changer in Cancer Treatment?

Keytruda has been hailed as a game-changer in cancer treatment due to its ability to provide durable responses in patients with advanced cancer. According to a study published in the Journal of Clinical Oncology, Keytruda has been shown to improve overall survival in patients with NSCLC, with a median overall survival of 10.3 months compared to 6.4 months with chemotherapy.

What is the Future of Keytruda in Cancer Treatment?

The future of Keytruda in cancer treatment looks bright, with ongoing research and development aimed at expanding its indications and improving its efficacy. According to a report by DrugPatentWatch.com, Keytruda is expected to maintain its market share in the immunotherapy market, with sales projected to reach $10.3 billion by 2025.

Conclusion

The FDA approval of Keytruda in 2014 marked a significant milestone in the history of cancer treatment. With its ability to provide durable responses in patients with advanced cancer, Keytruda has changed the face of cancer treatment. As research and development continue to advance, the future of Keytruda looks bright, with ongoing efforts aimed at expanding its indications and improving its efficacy.

Key Takeaways

* Keytruda is a monoclonal antibody that targets the PD-1 protein on the surface of T-cells.
* Keytruda was approved by the FDA in September 2014 for the treatment of patients with metastatic NSCLC.
* Keytruda has been approved for the treatment of several other types of cancer, including HNSCC, cHL, UC, MSI-H cancer, and RCC.
* Keytruda has been shown to improve overall survival in patients with NSCLC.
* The future of Keytruda looks bright, with ongoing research and development aimed at expanding its indications and improving its efficacy.

FAQs

Q: What is Keytruda used for?
A: Keytruda is used to treat patients with advanced cancer, including NSCLC, HNSCC, cHL, UC, MSI-H cancer, and RCC.

Q: How does Keytruda work?
A: Keytruda works by blocking the PD-1 protein on the surface of T-cells, allowing the immune system to recognize and destroy cancer cells.

Q: What are the side effects of Keytruda?
A: Common side effects of Keytruda include fatigue, rash, and diarrhea.

Q: Is Keytruda a cure for cancer?
A: Keytruda is not a cure for cancer, but it has been shown to provide durable responses in patients with advanced cancer.

Q: What is the future of Keytruda in cancer treatment?
A: The future of Keytruda looks bright, with ongoing research and development aimed at expanding its indications and improving its efficacy.

Sources:

1. FDA Approval of Keytruda. (2014). Retrieved from <https://www.fda.gov/drugs/information-drug-class/pembrolizumab>
2. DrugPatentWatch.com. (2020). Pembrolizumab (Keytruda) Patent Expiration. Retrieved from <https://www.drugpatentwatch.com/patent/US-20130214251>
3. Journal of Clinical Oncology. (2016). Pembrolizumab in Patients with Advanced Non-Small-Cell Lung Cancer. Retrieved from <https://jco.ascopubs.org/content/34/17/1970>
4. National Cancer Institute. (2020). Pembrolizumab. Retrieved from <https://www.cancer.gov/about-cancer/treatment/drugs/pembrolizumab>
5. Merck & Co., Inc. (2020). Keytruda (pembrolizumab) Prescribing Information. Retrieved from <https://www.merck.com/product/usa/picirculars/k/keytruda/keytrudapi.pdf>