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When Did Keytruda Receive Initial FDA Approval for Any Cancer?

A Breakthrough in Cancer Treatment: The Story of Keytruda

In the world of oncology, few treatments have made as significant an impact as Keytruda, a groundbreaking immunotherapy developed by Merck & Co. Since its introduction, Keytruda has revolutionized the way we approach cancer treatment, offering new hope to patients and their families. But when did Keytruda first receive FDA approval for any cancer?

The Early Days of Keytruda

Keytruda, also known as pembrolizumab, is a monoclonal antibody that targets the PD-1 receptor on immune cells. This receptor is often exploited by cancer cells to evade the immune system, allowing them to grow and spread. By blocking the PD-1 receptor, Keytruda enables the immune system to recognize and attack cancer cells more effectively.

The FDA Approval Journey

Keytruda's journey to FDA approval began in 2014, when Merck submitted a new drug application (NDA) for the treatment of advanced melanoma. The FDA granted priority review status to the application, recognizing the potential of Keytruda to significantly improve patient outcomes.

Initial FDA Approval: Melanoma

On September 4, 2014, the FDA approved Keytruda for the treatment of patients with unresectable or metastatic melanoma, which had progressed after treatment with ipilimumab or a BRAF inhibitor. This marked the first FDA approval for Keytruda, and it paved the way for further approvals in other cancer types.

Subsequent FDA Approvals

Since its initial approval, Keytruda has received FDA approval for several other cancer types, including:

* Non-Small Cell Lung Cancer (NSCLC): In February 2017, the FDA approved Keytruda for the treatment of patients with advanced NSCLC, regardless of PD-L1 expression.
* Classical Hodgkin Lymphoma: In October 2017, the FDA approved Keytruda for the treatment of patients with classical Hodgkin lymphoma who have relapsed or progressed after autologous hematopoietic stem cell transplantation (AHCT) or three or more lines of systemic therapy.
* Head and Neck Squamous Cell Carcinoma (HNSCC): In March 2019, the FDA approved Keytruda for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.
* Cervical Cancer: In November 2019, the FDA approved Keytruda for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

The Future of Keytruda

With its impressive track record of FDA approvals, Keytruda is poised to continue playing a significant role in the treatment of various cancer types. As researchers continue to explore the potential of immunotherapy, we can expect to see even more exciting developments in the future.

Conclusion

Keytruda's journey to FDA approval began with a groundbreaking approval in melanoma in 2014. Since then, the treatment has received approval for several other cancer types, offering new hope to patients and their families. As we look to the future, it's clear that Keytruda will continue to be a game-changer in the fight against cancer.

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, head and neck squamous cell carcinoma, and cervical cancer.
2. How does Keytruda work?
Keytruda works by blocking the PD-1 receptor on immune cells, allowing the immune system to recognize and attack cancer cells more effectively.
3. What is the most common side effect of Keytruda?
The most common side effects of Keytruda include fatigue, rash, and diarrhea.
4. Can Keytruda be used in combination with other treatments?
Yes, Keytruda can be used in combination with other treatments, such as chemotherapy or radiation therapy.
5. Is Keytruda available in all countries?
No, Keytruda is not available in all countries. Availability may vary depending on the country and region.

Sources:

1. Merck & Co. (2014). Merck Submits New Drug Application to U.S. FDA for Pembrolizumab (MK-3475) for the Treatment of Advanced Melanoma.
2. FDA (2014). FDA Approves Keytruda (pembrolizumab) for Advanced Melanoma.
3. DrugPatentWatch.com. Pembrolizumab (Keytruda) Patent Expiration.
4. Merck & Co. (2017). FDA Approves Keytruda (pembrolizumab) for Advanced Non-Small Cell Lung Cancer.
5. FDA (2017). FDA Approves Keytruda (pembrolizumab) for Classical Hodgkin Lymphoma.
6. Merck & Co. (2019). FDA Approves Keytruda (pembrolizumab) for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma.
7. FDA (2019). FDA Approves Keytruda (pembrolizumab) for Recurrent or Metastatic Cervical Cancer.