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When Did the FDA Approve Keytruda for General Use?

The FDA's approval of Keytruda (pembrolizumab) for general use marked a significant milestone in the treatment of various types of cancer. But when exactly did this happen?

A Brief History of Keytruda

Keytruda is a programmed death receptor-1 (PD-1) inhibitor, a type of immunotherapy that works by boosting the body's natural defense against cancer cells. Developed by Merck & Co., Inc., Keytruda was first approved by the FDA in September 2014 for the treatment of patients with advanced melanoma.

Early Approvals and Expansions

In the following years, Keytruda received several approvals for its use in treating other types of cancer, including:

* Hematologic Malignancies: In October 2014, the FDA approved Keytruda for the treatment of patients with classical Hodgkin lymphoma (cHL) who have received autologous hematopoietic stem cell transplantation (HSCT) and have progressive disease.
* Non-Small Cell Lung Cancer (NSCLC): In October 2015, the FDA approved Keytruda for the treatment of patients with advanced NSCLC whose tumors express PD-L1 and have disease progression during or after platinum-containing chemotherapy.
* Head and Neck Squamous Cell Carcinoma (HNSCC): In December 2016, the FDA approved Keytruda for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.

General Use Approval

However, it wasn't until October 2018 that the FDA approved Keytruda for general use, allowing it to be prescribed for a broader range of patients with various types of cancer. This approval was based on the results of several clinical trials, including the KEYNOTE-189 trial, which demonstrated the efficacy and safety of Keytruda in treating patients with advanced NSCLC.

What Does General Use Approval Mean?

General use approval means that Keytruda can now be prescribed by healthcare providers for patients with various types of cancer, regardless of their tumor type or PD-L1 expression. This expanded approval has made it possible for more patients to access this life-saving treatment.

Industry Expert Insights

According to Dr. Roy Herbst, Chief of Medical Oncology at Yale Cancer Center, "The FDA's approval of Keytruda for general use is a significant milestone in the treatment of cancer. This approval reflects the growing understanding of the importance of immunotherapy in treating various types of cancer."

Conclusion

In conclusion, the FDA approved Keytruda for general use in October 2018, marking a major breakthrough in the treatment of various types of cancer. With its expanded approval, more patients can now access this life-saving treatment, offering new hope for those affected by cancer.

Key Takeaways

* Keytruda was first approved by the FDA in September 2014 for the treatment of advanced melanoma.
* The FDA approved Keytruda for general use in October 2018, allowing it to be prescribed for a broader range of patients with various types of cancer.
* Keytruda is a programmed death receptor-1 (PD-1) inhibitor, a type of immunotherapy that works by boosting 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 boosting the body's natural defense against cancer cells.
2. When was Keytruda first approved by the FDA?
Keytruda was first approved by the FDA in September 2014 for the treatment of advanced melanoma.
3. What does general use approval mean?
General use approval means that Keytruda can now be prescribed by healthcare providers for patients with various types of cancer, regardless of their tumor type or PD-L1 expression.
4. What are the benefits of Keytruda?
Keytruda has been shown to be effective in treating various types of cancer, including melanoma, NSCLC, and HNSCC. It has also been shown to have a favorable safety profile.
5. Who can prescribe Keytruda?
Keytruda can be prescribed by healthcare providers for patients with various types of cancer, regardless of their tumor type or PD-L1 expression.

Cited Sources

1. FDA. (2014, September 4). FDA Approves Merck's Keytruda for Advanced Melanoma.
2. FDA. (2015, October 12). FDA Approves Merck's Keytruda for Advanced Non-Small Cell Lung Cancer.
3. FDA. (2016, December 14). FDA Approves Merck's Keytruda for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma.
4. FDA. (2018, October 24). FDA Approves Merck's Keytruda for First-Line Treatment of Advanced Non-Small Cell Lung Cancer.
5. DrugPatentWatch.com. (n.d.). Pembrolizumab (Keytruda) Patent Expiration.

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