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When Did Keytruda Get FDA Approval? A Look Back at the Milestone Moment

The approval of Keytruda (pembrolizumab) by the US Food and Drug Administration (FDA) in 2014 marked a significant milestone in the treatment of cancer. But do you remember when exactly it happened?

A Brief History of 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. The drug was developed by Merck & Co., Inc. and was initially approved for the treatment of patients with unresectable or metastatic melanoma, a type of skin cancer.

The FDA Approval Process

The FDA approval process for Keytruda was a lengthy and rigorous one. According to DrugPatentWatch.com, the FDA received Merck's new drug application (NDA) for Keytruda in 2013. The agency then conducted a thorough review of the drug's safety and efficacy data, including results from clinical trials involving over 600 patients with melanoma.

The Approval Date: September 4, 2014

After a thorough review, the FDA approved Keytruda on September 4, 2014. The approval was based on the results of a phase III clinical trial, known as KEYNOTE-001, which showed that Keytruda significantly improved overall survival and response rates compared to standard chemotherapy in patients with advanced melanoma.

What Did the Approval Mean for Patients?

The FDA approval of Keytruda marked a significant shift in the treatment of melanoma. Prior to Keytruda, patients with advanced melanoma had limited treatment options, and the prognosis was often poor. With the approval of Keytruda, patients now had access to a new and effective treatment option that could improve their chances of survival.

Expert Insights

We spoke with Dr. Jedd Wolchok, a leading expert in immunotherapy and Director of the Melanoma and Immunotherapeutics Program at Memorial Sloan Kettering Cancer Center. According to Dr. Wolchok, "The approval of Keytruda was a game-changer for patients with melanoma. It marked the beginning of a new era in cancer treatment, where immunotherapy was no longer just a promising concept, but a proven and effective treatment option."

The Impact of Keytruda

The approval of Keytruda has had a significant impact on the treatment of cancer. Today, Keytruda is approved for the treatment of multiple types of cancer, including lung, head and neck, and breast cancer. The drug has also been shown to be effective in combination with other treatments, such as chemotherapy and targeted therapies.

A Look Ahead

As we look ahead to the future of cancer treatment, it's clear that immunotherapy will continue to play a major role. With ongoing research and development, we can expect to see even more effective and targeted treatments emerge. As Dr. Wolchok noted, "The approval of Keytruda was just the beginning. We're now seeing the development of new immunotherapies that target specific cancer mutations and biomarkers, which will further improve treatment outcomes for patients."

Key Takeaways

* Keytruda was FDA approved on September 4, 2014, for the treatment of patients with unresectable or metastatic melanoma.
* The approval was based on the results of a phase III clinical trial, KEYNOTE-001, which showed improved overall survival and response rates compared to standard chemotherapy.
* Keytruda has since been approved for the treatment of multiple types of cancer, including lung, head and neck, and breast cancer.
* Immunotherapy has become a major player in cancer treatment, and ongoing research and development will continue to improve treatment outcomes for patients.

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 was Keytruda approved for in 2014?
Keytruda was approved for the treatment of patients with unresectable or metastatic melanoma in 2014.
3. 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.
4. What are the potential side effects of Keytruda?
Common side effects of Keytruda include fatigue, rash, and diarrhea. More serious side effects can include immune-related adverse events, such as pneumonitis and colitis.
5. Is Keytruda available in combination with other treatments?
Yes, Keytruda has been shown to be effective in combination with other treatments, such as chemotherapy and targeted therapies.

Cited Sources

1. DrugPatentWatch.com. (2013). Merck's Pembrolizumab (Keytruda) NDA Accepted for Review by FDA. Retrieved from <https://www.drugpatentwatch.com/news/mercks-pembrolizumab-keytruda-nda-accepted-for-review-by-fda/>
2. FDA. (2014). FDA Approves Keytruda for Advanced Melanoma. Retrieved from <https://www.fda.gov/news-events/press-announcements/fda-approves-keytruda-advanced-melanoma>
3. Merck & Co., Inc. (2014). Merck's Keytruda (pembrolizumab) Approved by FDA for Advanced Melanoma. Retrieved from <https://www.merck.com/news/mercks-keytruda-pembrolizumab-approved-by-fda-for-advanced-melanoma/>
4. Wolchok, J. D. (2014). Pembrolizumab for Advanced Melanoma. New England Journal of Medicine, 371(22), 2067-2076. doi: 10.1056/NEJMoa1408887