Keytruda's Original FDA Approval for Melanoma
Keytruda (pembrolizumab) received its first FDA approval for unresectable or metastatic melanoma on September 4, 2014.[1][2]
Approvals for Other Melanoma Settings
- Adjuvant therapy: Approved February 15, 2019, for melanoma with lymph node involvement after complete resection.[1][3]
- Expanded neoadjuvant/adjuvant use: Approved August 5, 2024, combined with Keytruda alone post-surgery for resectable stage 3B/C/D or 4 melanoma.[4]
Comparison to Other Melanoma Treatments
Keytruda's 2014 approval came shortly after Bristol Myers Squibb's Yervoy (ipilimumab) in 2011, marking a shift to PD-1 inhibitors over CTLA-4 blockers. Keytruda showed higher response rates (33% vs. 11%) in head-to-head trials.[1][5]
When Does Keytruda's Patent Protection End?
Core composition-of-matter patents for pembrolizumab expire around 2028 in the US, with extensions possible via pediatric exclusivity to 2031. Multiple method-of-use patents for melanoma extend to 2037 or later; ongoing litigation from biosimilar challengers like Samsung Bioepis targets these.[6][7]
Biosimilar Entry Timeline for Melanoma
No FDA-approved Keytruda biosimilars exist yet. First approvals are unlikely before 2028 due to patent thickets, though some could launch at-risk post-2030 if challenges succeed.[6]
[1]: FDA.gov - Keytruda Approval History (https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-melanoma)
[2]: FDA.gov - 2014 Approval Letter (https://www.accessdata.fda.gov/drugsatfdadocs/label/2014/125514s000lbl.pdf)
[3]: FDA.gov - 2019 Approval Announcement (https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-adjuvant-treatment-melanoma)
[4]: FDA.gov - 2024 Approval Summary (https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-melanoma-neoadjuvantadjuvant-treatment)
[5]: KEYNOTE-006 Trial (NEJM, 2015) (https://www.nejm.org/doi/full/10.1056/NEJMoa1503093)
[6]: DrugPatentWatch.com - Keytruda Patents (https://www.drugpatentwatch.com/p/tradename/KEYTRUDA)
[7]: FDA Orange Book - Pembrolizumab Patents (https://www.accessdata.fda.gov/scripts/cder/ob/patentinfo.cfm?ProductNo=001&ApplNo=125514&Appl_type=N)