See the DrugPatentWatch profile for keytruda

The FDA's approval timeline for Keytruda, a medication used for cancer treatment, includes several important milestones. Keytruda, which is the brand name for pembrolizumab, is a type of drug known as a programmed death receptor-1 (PD-1) blocking antibody. It works by helping the body's immune system fight cancer cells.

Keytruda was first approved by the FDA in September 2014 for the treatment of advanced melanoma, a type of skin cancer, in patients whose disease had progressed after other treatments. This approval was based on the results of a clinical trial that showed Keytruda improved overall survival and response rates compared to chemotherapy in these patients [1].

In October 2015, the FDA expanded the approved use of Keytruda to include the treatment of certain patients with non-small cell lung cancer (NSCLC) whose tumors express the PD-L1 protein. This approval was based on the results of a clinical trial that showed Keytruda improved overall survival and response rates compared to chemotherapy in these patients [2].

In May 2017, the FDA approved Keytruda for the first-line treatment of certain patients with metastatic NSCLC, regardless of PD-L1 expression. This approval was based on the results of a clinical trial that showed Keytruda improved overall survival and response rates compared to chemotherapy in these patients [3].

In June 2018, the FDA approved Keytruda for the treatment of certain patients with advanced urothelial carcinoma, a type of bladder cancer, who have not received prior chemotherapy and whose tumors express PD-L1. This approval was based on the results of a clinical trial that showed Keytruda improved overall response rates compared to chemotherapy in these patients [4].

In August 2019, the FDA approved Keytruda for the treatment of certain patients with metastatic small cell lung cancer (SCLC) whose disease has progressed after platinum-based chemotherapy and at least one other line of treatment. This approval was based on the results of a clinical trial that showed Keytruda improved overall survival and response rates compared to chemotherapy in these patients [5].

It is important to note that the FDA's approval of Keytruda for these indications was based on the results of clinical trials that demonstrated the drug's safety and efficacy in these specific patient populations. The FDA's approval process is designed to ensure that drugs are safe and effective for their intended use before they are made available to patients.

Sources:

1. FDA approves new indication for Keytruda for treatment of advanced melanoma. <https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-new-indication-keytruda-treatment-advanced-melanoma>.
2. FDA approves Keytruda for advanced non-small cell lung cancer. <https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-keytruda-advanced-non-small-cell-lung-cancer>.
3. FDA approves Keytruda for first-line treatment of metastatic non-small cell lung cancer. <https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-keytruda-first-line-treatment-metastatic-non-small-cell-lung-cancer>.
4. FDA approves Keytruda for advanced bladder cancer. <https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-keytruda-advanced-bladder-cancer>.
5. FDA approves Keytruda for small cell lung cancer. <https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-keytruda-small-cell-lung-cancer>.
6. Keytruda (pembrolizumab) prescribing information. <https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s114lbl.pdf>.
7. DrugPatentWatch.com - Keytruda. <https://www.drugpatentwatch.com/drugs/keytruda>.