In what year did keytruda gain fda approval for the first time?

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)