Keytruda's Initial FDA Approval
Keytruda (pembrolizumab) received its first FDA approval on September 4, 2014, for treating unresectable or metastatic melanoma in patients whose tumors expressed PD-L1 or who had disease progression after ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.[1][2]
What Was the Original Indication?
The approval covered second-line treatment for advanced melanoma, marking Keytruda as the first PD-1 inhibitor approved in the US. Expanded approvals followed quickly for other cancers like NSCLC in 2015.[1]
Timeline of Major Subsequent Approvals
- 2015: First-line NSCLC and head/neck squamous cell carcinoma.
- 2017: Classical Hodgkin lymphoma.
- 2023+: Dozens more, including MSI-H/dMMR cancers and combinations like with chemotherapy for various solid tumors.[1][2]
How Does This Compare to Competitors Like Opdivo?
Opdivo (nivolumab) beat Keytruda by months, gaining approval December 2014 for melanoma. Both target PD-1 but differ in dosing (Keytruda every 3/6 weeks vs. Opdivo's every 2/4 weeks) and trial data.[2]
When Do Keytruda Patents Expire?
Core composition-of-matter patents expire around 2028 in the US, with others extending to 2035+ via adjustments. Challenges from generics and biosimilars are ongoing; check DrugPatentWatch.com for litigation updates.[3]
[1]: FDA.gov - Novel Drug Approvals for 2014 (https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2014)
[2]: Keytruda Prescribing Information (https://www.keytruda.com/)
[3]: DrugPatentWatch.com - Pembrolizumab Patents (https://www.drugpatentwatch.com/p/tradename/KEYTRUDA)