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When Did Keytruda Receive Its Maiden FDA Approval?

A Breakthrough in Cancer Treatment

Keytruda, also known as pembrolizumab, is a revolutionary immunotherapy medication that has changed the landscape of cancer treatment. Developed by Merck & Co., Inc., Keytruda is a programmed death receptor-1 (PD-1) inhibitor that has shown remarkable efficacy in treating various types of cancer. But when did Keytruda receive its maiden FDA approval?

The Journey to FDA Approval

Keytruda's journey to FDA approval began in 2009, when Merck & Co., Inc. acquired the rights to develop the medication from Ono Pharmaceutical Co., Ltd. The company conducted extensive clinical trials to evaluate the safety and efficacy of Keytruda in treating various types of cancer.

The Breakthrough

In 2014, Keytruda received breakthrough therapy designation from the FDA for the treatment of advanced melanoma. This designation was granted based on the medication's promising results in clinical trials, which showed significant improvements in overall survival and response rates compared to standard therapies.

The Maiden FDA Approval

On September 4, 2014, the FDA granted Keytruda its maiden approval for the treatment of patients with unresectable or metastatic melanoma who have progressed after prior treatment with ipilimumab and BRAF-targeted therapy, if applicable. This approval marked a significant milestone in the development of immunotherapy treatments for cancer.

The Approval Process

The FDA's approval process for Keytruda involved a thorough review of data from clinical trials, including the Phase I KEYNOTE-001 trial, which evaluated the safety and efficacy of Keytruda in patients with advanced melanoma. The trial results showed that Keytruda significantly improved overall survival and response rates compared to standard therapies.

What Does This Mean for Cancer Patients?

The FDA approval of Keytruda for the treatment of advanced melanoma marked a significant breakthrough in cancer treatment. For the first time, patients with this aggressive and often deadly form of skin cancer had a new treatment option that offered improved survival rates and response rates compared to standard therapies.

The Future of Cancer Treatment

The approval of Keytruda has paved the way for the development of other immunotherapy treatments for various types of cancer. As researchers continue to explore the potential of immunotherapy, we can expect to see even more innovative treatments emerge in the future.

Conclusion

In conclusion, Keytruda received its maiden FDA approval on September 4, 2014, for the treatment of patients with unresectable or metastatic melanoma who have progressed after prior treatment with ipilimumab and BRAF-targeted therapy, if applicable. This approval marked a significant milestone in the development of immunotherapy treatments for cancer and has paved the way for the development of new and innovative treatments.

FAQs

1. What is Keytruda?
Keytruda is a programmed death receptor-1 (PD-1) inhibitor that is used to treat various types of cancer.
2. What is the FDA's breakthrough therapy designation?
The FDA's breakthrough therapy designation is granted to medications that have shown significant improvement over existing treatments in clinical trials.
3. What is the most common side effect of Keytruda?
The most common side effects of Keytruda include fatigue, rash, and decreased appetite.
4. Who is eligible for Keytruda treatment?
Keytruda is approved for the treatment of patients with unresectable or metastatic melanoma who have progressed after prior treatment with ipilimumab and BRAF-targeted therapy, if applicable.
5. What is the future of cancer treatment?
The future of cancer treatment is expected to involve the development of new and innovative treatments, including immunotherapy and targeted therapies.

Sources

1. Merck & Co., Inc. (2014). Merck's Keytruda (pembrolizumab) Receives FDA Approval for the Treatment of Patients with Unresectable or Metastatic Melanoma. Retrieved from <https://www.merck.com/news/mercks-keytruda-pembrolizumab-receives-fda-approval-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-9248334-B2>
3. FDA. (2014). FDA Approves Keytruda for Advanced Melanoma. Retrieved from <https://www.fda.gov/news-events/press-announcements/fda-approves-keytruda-advanced-melanoma>