Keytruda's First FDA Approval
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 Approved For Initially?
The maiden approval targeted advanced melanoma, marking Keytruda as the first PD-1 inhibitor approved in the US. It was granted accelerated approval based on tumor response rates and duration from the KEYNOTE-001 trial.[1]
How Has Its Label Expanded Since 2014?
FDA has since approved Keytruda for over 30 indications, including non-small cell lung cancer (October 2015), head and neck squamous cell carcinoma (2016), and many others like Hodgkin lymphoma and triple-negative breast cancer. Expansions often rely on accelerated approvals later converted to full based on confirmatory trials.[1][3]
When Do Keytruda Patents Expire?
Core composition-of-matter patents for pembrolizumab expire in 2028 (US Patent 8,354,509), with others extending protection into the 2030s via formulation, method-of-use, and pediatric exclusivity. Challenges from biosimilar makers like Samsung Bioepis are ongoing.[4][2]
Who Makes Keytruda and What's the Competition?
Merck & Co. (MSD outside the US) manufactures and markets Keytruda, the world's top-selling drug with $25 billion in 2023 sales. Main rivals include Bristol Myers Squibb's Opdivo (nivolumab), also a PD-1 inhibitor approved shortly after in 2014.[1][3]
[1]: FDA Approval History - https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125514lbl.pdf
[2]: Drugs@FDA - https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125514
[3]: Merck Press Release (2014) - https://www.merck.com/news/merck-receives-fda-approval-for-keytruda-pembrolizumab/
[4]: DrugPatentWatch.com - https://www.drugpatentwatch.com/p/tradename/KEYTRUDA