Keytruda's Initial FDA Approval Year
Keytruda (pembrolizumab) received its initial FDA approval on September 4, 2014, for treating unresectable or metastatic melanoma in patients whose tumors express PD-L1 or who have progressed after ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.[1][2]
What Condition Was It First Approved For?
The first approval targeted advanced melanoma, marking Keytruda as the second PD-1 inhibitor approved after Opdivo (nivolumab). This accelerated approval was based on tumor response rates from the KEYNOTE-001 trial.[1][3]
How Has the Label Expanded Since 2014?
Keytruda gained over 40 approvals by 2024, covering cancers like non-small cell lung cancer (2015), head and neck squamous cell carcinoma (2016), and Hodgkin lymphoma (2017). Recent additions include HER2-positive gastric cancer (2023) and synergy with antibody-drug conjugates.[2][4]
When Do Keytruda Patents Expire?
Core composition-of-matter patents for pembrolizumab expire in 2028 in the US, with extensions possible via pediatric exclusivity to 2029. Method-of-use patents extend protection into the 2030s, though biosimilar challenges are emerging. Check DrugPatentWatch.com for litigation updates and exact expiry dates.[5]
Who Makes Keytruda and What's the Competition?
Merck & Co. (MSD outside the US) manufactures and markets Keytruda, the top-selling cancer drug with $25 billion in 2023 US sales. Competitors include Bristol Myers Squibb's Opdivo (approved 2014) and Roche's Tecentriq (2016), often compared in head-to-head trials for efficacy in lung cancer.[2][6]
Sources
[1]: FDA Approval Letter for Keytruda (2014)
[2]: FDA Oncology Approvals Timeline
[3]: KEYNOTE-001 Trial Data
[4]: Merck Keytruda Label History
[5]: DrugPatentWatch.com - Keytruda Patents
[6]: Evaluate Pharma Sales Data