See the DrugPatentWatch profile for keytruda
Keytruda (pembrolizumab) is a programmed death receptor-1 (PD-1) inhibitor, a type of immunotherapy that helps the body's immune system fight cancer. The FDA approved Keytruda in September 2014 for the treatment of patients with unresectable or metastatic melanoma and disease progression after ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.
However, the FDA approval for overall cancer treatment came later. In October 2015, the FDA approved Keytruda for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or after platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.
In 2017, the FDA expanded the approval of Keytruda to include treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. This marked the first FDA approval of a PD-1 inhibitor for cervical cancer.
In 2018, the FDA approved Keytruda in combination with pemetrexed and carboplatin for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.
In 2020, the FDA approved Keytruda in combination with chemotherapy for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.
Keytruda has also been approved for the treatment of patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options.
Sources:
1. FDA. (2014, September 5). FDA Approves Merck's Keytruda for Advanced Melanoma. Retrieved from <
https://www.fda.gov/news-events/press-announcements/fda-approves-mercks-keytruda-advanced-melanoma>
2. FDA. (2015, October 22). FDA Approves Merck's Keytruda for Advanced Bladder Cancer. Retrieved from <
https://www.fda.gov/news-events/press-announcements/fda-approves-mercks-keytruda-advanced-bladder-cancer>
3. FDA. (2017, March 24). FDA Approves Merck's Keytruda for Advanced Cervical Cancer. Retrieved from <
https://www.fda.gov/news-events/press-announcements/fda-approves-mercks-keytruda-advanced-cervical-cancer>
4. FDA. (2018, February 9). FDA Approves Merck's Keytruda for Advanced Non-Small Cell Lung Cancer. Retrieved from <
https://www.fda.gov/news-events/press-announcements/fda-approves-mercks-keytruda-advanced-non-small-cell-lung-cancer>
5. FDA. (2020, January 8). FDA Approves Merck's Keytruda for Advanced Squamous Non-Small Cell Lung Cancer. Retrieved from <
https://www.fda.gov/news-events/press-announcements/fda-approves-mercks-keytruda-advanced-squamous-non-small-cell-lung-cancer>
6. DrugPatentWatch.com. (n.d.). Pembrolizumab (Keytruda). Retrieved from <
https://www.drugpatentwatch.com/patent/US-9314441>
Note: The above information is based on publicly available data and may not reflect the most up-to-date information.