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Keytruda's Journey to FDA Approval: A Timeline of Triumph

The story of Keytruda, a groundbreaking immunotherapy drug, is a testament to the power of innovation and perseverance in the field of medicine. Developed by Merck & Co., Inc., Keytruda has revolutionized the treatment of various types of cancer, including melanoma, lung cancer, and head and neck cancer. But when did this remarkable drug first gain FDA approval? Let's take a closer look at the timeline of Keytruda's journey to FDA approval.

Early Beginnings

Keytruda, also known as pembrolizumab, is a programmed death receptor-1 (PD-1) inhibitor, a type of immunotherapy that works by enhancing the body's natural defense against cancer cells. The development of Keytruda began in the early 2000s, when researchers at Merck & Co., Inc. identified the potential of PD-1 inhibitors in treating cancer.

Clinical Trials

In 2009, Merck & Co., Inc. initiated a Phase I clinical trial to evaluate the safety and efficacy of Keytruda in patients with advanced melanoma. The trial, known as MK-3475-001, was a dose-escalation study that aimed to determine the maximum tolerated dose of the drug.

Breakthrough Therapy Designation

In 2014, the FDA granted Keytruda Breakthrough Therapy Designation for the treatment of patients with unresectable or metastatic melanoma who have progressed after prior therapy. This designation was based on the results of a Phase I clinical trial, which showed that Keytruda was able to achieve a response rate of 38% in patients with advanced melanoma.

FDA Approval

On September 4, 2014, the FDA approved Keytruda for the treatment of patients with unresectable or metastatic melanoma who have progressed after prior therapy. This marked the first FDA approval of a PD-1 inhibitor and a major milestone in the development of immunotherapy.

Expansion of Indications

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

* Lung Cancer: In 2015, Keytruda was approved for the treatment of patients with advanced non-small cell lung cancer (NSCLC) who have progressed after prior therapy.
* Head and Neck Cancer: In 2016, Keytruda was approved for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who have progressed after prior therapy.
* Classical Hodgkin Lymphoma: In 2017, Keytruda was approved for the treatment of patients with classical Hodgkin lymphoma who have relapsed or progressed after prior therapy.

Current Status

Today, Keytruda is approved for the treatment of several types of cancer, including melanoma, lung cancer, head and neck cancer, and classical Hodgkin lymphoma. It is also being studied in various clinical trials for the treatment of other types of cancer, including breast cancer, pancreatic cancer, and multiple myeloma.

Key Takeaways

* Keytruda was first approved by the FDA on September 4, 2014, for the treatment of patients with unresectable or metastatic melanoma who have progressed after prior therapy.
* The drug has since gained approval for the treatment of several other types of cancer, including lung cancer, head and neck cancer, and classical Hodgkin lymphoma.
* Keytruda is a programmed death receptor-1 (PD-1) inhibitor, a type of immunotherapy that works by enhancing the body's natural defense against cancer cells.

FAQs

1. What is Keytruda?
Keytruda is a programmed death receptor-1 (PD-1) inhibitor, a type of immunotherapy that works by enhancing the body's natural defense against cancer cells.
2. 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.
3. What types of cancer is Keytruda approved for?
Keytruda is approved for the treatment of patients with unresectable or metastatic melanoma, advanced non-small cell lung cancer (NSCLC), recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), and classical Hodgkin lymphoma.
4. What is the most common side effect of Keytruda?
The most common side effects of Keytruda include fatigue, musculoskeletal pain, and decreased appetite.
5. Is Keytruda available in the United States?
Yes, Keytruda is available in the United States and is marketed by Merck & Co., Inc.

Sources

1. Merck & Co., Inc. (2014). FDA Approves Keytruda (pembrolizumab) for the Treatment of Patients with Unresectable or Metastatic Melanoma. Retrieved from <https://www.merck.com/news/fda-approves-keytruda-pembrolizumab-for-the-treatment-of-patients-with-unresectable-or-metastatic-melanoma/>
2. DrugPatentWatch.com. (n.d.). Pembrolizumab (Keytruda). Retrieved from <https://www.drugpatentwatch.com/patent/US-2014-024-001>
3. National Cancer Institute. (n.d.). Pembrolizumab. Retrieved from <https://www.cancer.gov/about-cancer/treatment/types/immunotherapy/pembrolizumab-fact-sheet>

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