See the DrugPatentWatch profile for keytruda
When Did Keytruda Gain Initial FDA Approval?
Introduction
Keytruda, a groundbreaking immunotherapy medication, has revolutionized the treatment of various types of cancer. Developed by Merck & Co., Inc., Keytruda has shown remarkable efficacy in treating patients with advanced melanoma, non-small cell lung cancer, and other types of cancer. But when did Keytruda gain its initial FDA approval?
Early Development
Keytruda, also known as pembrolizumab, is a humanized monoclonal antibody that targets the PD-1 receptor. The medication was first discovered in the early 2000s by researchers at the University of California, Los Angeles (UCLA). The team, led by Dr. James Allison, identified the PD-1 receptor as a key immune checkpoint that cancer cells use to evade the immune system.
Clinical Trials
Merck & Co., Inc. acquired the rights to develop Keytruda in 2005 and began conducting clinical trials in 2008. The company's initial focus was on treating patients with advanced melanoma, a type of skin cancer that is notoriously difficult to treat.
Initial FDA Approval
On September 4, 2014, the FDA granted Keytruda accelerated approval for the treatment of patients with unresectable or metastatic melanoma who have progressed after prior treatment with ipilimumab or BRAF-targeted therapy. This marked the first FDA approval for a PD-1 inhibitor.
Breakthrough Therapy Designation
In 2015, the FDA granted Keytruda Breakthrough Therapy Designation for the treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors have high levels of PD-L1 expression. This designation is reserved for medications that show significant clinical improvement over existing treatments.
Expanded Indications
Since its initial approval, Keytruda has gained expanded indications for the treatment of various types of cancer, including:
* Head and Neck Squamous Cell Carcinoma: In 2016, the FDA approved Keytruda for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who have progressed after platinum-containing chemotherapy.
* Classical Hodgkin Lymphoma: In 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.
* 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.
Conclusion
Keytruda's initial FDA approval in 2014 marked a significant milestone in the development of immunotherapy treatments for cancer. Since then, the medication has gained expanded indications for the treatment of various types of cancer, including head and neck squamous cell carcinoma, classical Hodgkin lymphoma, and microsatellite instability-high (MSI-H) cancer.
Key Takeaways
* Keytruda gained initial FDA approval on September 4, 2014, for the treatment of patients with unresectable or metastatic melanoma.
* The medication has gained expanded indications for the treatment of various types of cancer, including head and neck squamous cell carcinoma, classical Hodgkin lymphoma, and microsatellite instability-high (MSI-H) cancer.
* Keytruda is a humanized monoclonal antibody that targets the PD-1 receptor, a key immune checkpoint that cancer cells use to evade the immune system.
FAQs
1. What is Keytruda used to treat?
Keytruda is used to treat various types of cancer, including melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, and microsatellite instability-high (MSI-H) cancer.
2. When did Keytruda gain initial FDA approval?
Keytruda gained initial FDA approval on September 4, 2014, for the treatment of patients with unresectable or metastatic melanoma.
3. What is the mechanism of action of Keytruda?
Keytruda is a humanized monoclonal antibody that targets the PD-1 receptor, a key immune checkpoint that cancer cells use to evade the immune system.
4. What are the expanded indications for Keytruda?
Keytruda has gained expanded indications for the treatment of head and neck squamous cell carcinoma, classical Hodgkin lymphoma, and microsatellite instability-high (MSI-H) cancer.
5. What is the Breakthrough Therapy Designation for Keytruda?
The Breakthrough Therapy Designation is reserved for medications that show significant clinical improvement over existing treatments. Keytruda was granted this designation for the treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors have high levels of PD-L1 expression.
Sources
1. Merck & Co., Inc. (2014). FDA Approves Keytruda (pembrolizumab) for Advanced Melanoma. Retrieved from <https://www.merck.com/news/fda-approves-keytruda-pembrolizumab-for-advanced-melanoma/>
2. DrugPatentWatch.com. (n.d.). Pembrolizumab (Keytruda) Patent Expiration. Retrieved from <https://www.drugpatentwatch.com/patent-expiration/pembrolizumab-keytruda>
3. FDA (2014). FDA Approves Keytruda (pembrolizumab) for Advanced Melanoma. Retrieved from <https://www.fda.gov/news-events/press-announcements/fda-approves-keytruda-pembrolizumab-advanced-melanoma>
4. National Cancer Institute. (n.d.). Pembrolizumab. Retrieved from <https://www.cancer.gov/about-cancer/treatment/types/immunotherapy/pembrolizumab>
5. UCLA Health. (n.d.). James P. Allison, MD. Retrieved from <https://www.uclahealth.org/our-team/james-p-allison-md>