See the DrugPatentWatch profile for keytruda

Keytruda's Initial FDA-Approved Cancer Indication: A Breakthrough in Immunotherapy

The FDA's approval of Keytruda (pembrolizumab) in 2014 marked a significant milestone in the treatment of cancer. But what was the initial FDA-approved cancer indication for this groundbreaking immunotherapy drug? In this article, we'll delve into the history of Keytruda's development and explore its initial FDA-approved indication.

The Birth of Keytruda

Keytruda is a programmed death receptor-1 (PD-1) inhibitor, a type of immunotherapy that works by blocking the PD-1 protein on T-cells, allowing them to recognize and attack cancer cells more effectively. The development of Keytruda began in the early 2000s, when researchers at Merck & Co. Inc. discovered the potential of PD-1 inhibitors in treating cancer.

The First FDA Approval

On September 4, 2014, the FDA approved Keytruda for the treatment of patients with unresectable or metastatic melanoma, a type of skin cancer, who have progressed after treatment with ipilimumab (Yervoy) or a BRAF inhibitor (e.g., vemurafenib, Zelboraf). This approval marked the first FDA approval of a PD-1 inhibitor and paved the way for the use of immunotherapy in other types of cancer.

The Science Behind the Approval

The approval of Keytruda was based on the results of a phase III clinical trial, known as KEYNOTE-006, which compared the efficacy and safety of Keytruda to ipilimumab in patients with unresectable or metastatic melanoma. The study found that Keytruda significantly improved overall survival, progression-free survival, and objective response rate compared to ipilimumab.

The Impact of Keytruda's Initial FDA Approval

The initial FDA approval of Keytruda for melanoma treatment marked a significant shift in the treatment landscape for this disease. Prior to Keytruda's approval, treatment options for melanoma were limited, and patients often had poor outcomes. Keytruda's approval offered a new hope for patients with advanced melanoma, and its subsequent approvals for other indications have further expanded its use.

Keytruda's Expanded Indications

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

* Head and Neck Squamous Cell Carcinoma (HNSCC): Keytruda was approved in 2016 for the treatment of patients with recurrent or metastatic HNSCC who have progressed after platinum-containing chemotherapy.
* Non-Small Cell Lung Cancer (NSCLC): Keytruda was approved in 2017 for the treatment of patients with NSCLC who have progressed after platinum-containing chemotherapy and have a PD-L1 tumor proportion score (TPS) ≥1%.
* Classical Hodgkin Lymphoma (cHL): Keytruda was approved in 2017 for the treatment of patients with cHL who have relapsed or progressed after autologous stem cell transplantation and have a PD-1 positive tumor.
* Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer: Keytruda was approved in 2017 for the treatment of patients with MSI-H or dMMR colorectal cancer who have progressed after fluoropyrimidine-based chemotherapy.

Conclusion

Keytruda's initial FDA approval for the treatment of unresectable or metastatic melanoma marked a significant milestone in the development of immunotherapy for cancer treatment. Since then, Keytruda has been approved for several other indications, offering new hope for patients with a range of cancer types. As research continues to uncover the potential of immunotherapy, it's likely that Keytruda will play a key role in the treatment of many more patients with cancer.

FAQs

1. What was Keytruda's initial FDA-approved cancer indication?
Unresectable or metastatic melanoma.
2. What type of immunotherapy is Keytruda?
A programmed death receptor-1 (PD-1) inhibitor.
3. What was the name of the phase III clinical trial that led to Keytruda's initial FDA approval?
KEYNOTE-006.
4. What type of cancer was Keytruda approved for in 2016?
Head and Neck Squamous Cell Carcinoma (HNSCC).
5. What type of cancer was Keytruda approved for in 2017, in addition to NSCLC and cHL?
Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer.

Sources:

1. Merck & Co. Inc. (2014). FDA Approves Merck's KEYTRUDA (pembrolizumab) for Patients with Unresectable or Metastatic Melanoma.
2. DrugPatentWatch.com. (n.d.). Pembrolizumab (KEYTRUDA) Patent Expiration.
3. National Cancer Institute. (n.d.). Pembrolizumab.
4. FDA. (2014). FDA Approves Merck's KEYTRUDA (pembrolizumab) for Patients with Unresectable or Metastatic Melanoma.
5. Merck & Co. Inc. (2016). FDA Approves Merck's KEYTRUDA (pembrolizumab) for Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma.
6. FDA. (2017). FDA Approves Merck's KEYTRUDA (pembrolizumab) for Patients with Non-Small Cell Lung Cancer.
7. FDA. (2017). FDA Approves Merck's KEYTRUDA (pembrolizumab) for Patients with Classical Hodgkin Lymphoma.
8. FDA. (2017). FDA Approves Merck's KEYTRUDA (pembrolizumab) for Patients with Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer.