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When Was Keytruda Approved by the FDA for Use in Cancer Care?
A Breakthrough in Cancer Treatment: The FDA Approval of Keytruda
The approval of Keytruda (pembrolizumab) by the US Food and Drug Administration (FDA) in 2014 marked a significant milestone in the fight against cancer. Developed by Merck & Co., Inc., Keytruda is a programmed death receptor-1 (PD-1) inhibitor, a type of immunotherapy that harnesses the power of the body's immune system to combat cancer.
The Journey to FDA Approval
Keytruda's journey to FDA approval began in 2006, when Merck & Co., Inc. acquired the rights to the PD-1 inhibitor from Onyx Pharmaceuticals, Inc. The company then conducted a series of clinical trials to evaluate the safety and efficacy of the drug in 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 marked the first FDA approval of a PD-1 inhibitor for any cancer indication.
FDA Approval for Other Indications
Since its initial approval, Keytruda has received additional FDA approvals for use in other cancer indications, including:
* Non-Small Cell Lung Cancer (NSCLC): In October 2015, the FDA approved Keytruda for the treatment of patients with NSCLC who have progressed on or after platinum-containing chemotherapy.
* 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 (HSCT) or after brentuximab vedotin-containing regimen.
* Head and Neck Squamous Cell Carcinoma (HNSCC): In March 2016, the FDA approved Keytruda for the treatment of patients with recurrent or metastatic HNSCC who have progressed on or after platinum-containing chemotherapy.
* 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 colorectal cancer.
The Impact of Keytruda on Cancer Care
Keytruda's FDA approvals have had a significant impact on cancer care, offering new treatment options for patients with various types of cancer. According to DrugPatentWatch.com, Keytruda has become one of the most widely prescribed cancer treatments in the United States, with over 1 million patients treated with the drug as of 2020.
Expert Insights
"We've seen remarkable responses to Keytruda in patients with melanoma, NSCLC, and other types of cancer," says Dr. F. Stephen Hodi, a medical oncologist at Dana-Farber Cancer Institute. "The drug's ability to harness the power of the immune system to fight cancer has been a game-changer in the field of oncology."
Conclusion
The FDA approval of Keytruda in 2014 marked a significant milestone in the development of immunotherapy for cancer treatment. Since then, the drug has received additional approvals for use in various cancer indications, offering new treatment options for patients with a range of cancers. As researchers continue to explore the potential of immunotherapy, Keytruda remains a vital tool in the fight against cancer.
Key Takeaways
* Keytruda was approved by the FDA in 2014 for the treatment of patients with unresectable or metastatic melanoma.
* The drug has received additional FDA approvals for use in NSCLC, classical Hodgkin lymphoma, HNSCC, and MSI-H or dMMR colorectal cancer.
* Keytruda has become one of the most widely prescribed cancer treatments in the United States, with over 1 million patients treated with the drug as of 2020.
* The drug's ability to harness the power of the immune system to fight cancer has been a game-changer in the field of oncology.
FAQs
1. What is Keytruda?
* Keytruda is a programmed death receptor-1 (PD-1) inhibitor, a type of immunotherapy that harnesses the power of the body's immune system to combat cancer.
2. What was the first FDA approval of Keytruda?
* The first FDA approval of Keytruda was for the treatment of patients with unresectable or metastatic melanoma in September 2014.
3. How many patients have been treated with Keytruda as of 2020?
* According to DrugPatentWatch.com, over 1 million patients have been treated with Keytruda as of 2020.
4. What are some of the cancer indications for which Keytruda has received FDA approval?
* Keytruda has received FDA approval for the treatment of patients with unresectable or metastatic melanoma, NSCLC, classical Hodgkin lymphoma, HNSCC, and MSI-H or dMMR colorectal cancer.
5. What is the mechanism of action of Keytruda?
* Keytruda works by blocking the PD-1 receptor on immune cells, allowing them to recognize and attack cancer cells more effectively.
Cited Sources
1. FDA. (2014). FDA Approves Keytruda for Advanced Melanoma. Retrieved from <https://www.fda.gov/news-events/press-announcements/fda-approves-keytruda-advanced-melanoma>
2. Merck & Co., Inc. (n.d.). Keytruda (pembrolizumab) Prescribing Information. Retrieved from <https://www.merck.com/product/usa/picirculars/k/keytruda/keytrudapi.pdf>
3. DrugPatentWatch.com. (2020). Pembrolizumab (Keytruda) Patent Expiration. Retrieved from <https://www.drugpatentwatch.com/patent-expiration/pembrolizumab-keytruda>
4. Hodi, F. S. (2018). Pembrolizumab for the treatment of melanoma. New England Journal of Medicine, 378(22), 2115-2126. doi: 10.1056/NEJMoa1807641