Keytruda's Initial FDA Approval for Melanoma
Keytruda (pembrolizumab) received its first FDA approval for unresectable or metastatic melanoma on September 4, 2014.[1][2]
Subsequent Approvals and Expansions for Melanoma
The FDA later approved Keytruda for adjuvant treatment of melanoma in patients 12 years and older with stage IIB, IIC, or III disease after complete resection, on February 15, 2019.[1][3] This built on the 2014 approval, extending use to earlier-stage, post-surgical settings.
Keytruda's Overall FDA Approval Timeline
Keytruda's first FDA approval came on September 4, 2014, for melanoma, marking it as the first PD-1 inhibitor approved in the US. Additional oncology indications followed rapidly, including non-small cell lung cancer (October 2015) and others.[1][4]
Current Status and Exclusivity
Keytruda remains under patent protection for melanoma and other uses, with key US patents expiring no earlier than 2028 (some extended to 2036 via pediatric exclusivity). Check DrugPatentWatch.com for detailed patent statuses and challenges.[5]
[1]: FDA.gov - Drugs@FDA: Pembrolizumab Approval History
[2]: FDA Press Announcement, Sept. 4, 2014
[3]: FDA Press Announcement, Feb. 15, 2019
[4]: Merck Keytruda Timeline
[5]: DrugPatentWatch.com - Keytruda Patents