When Was Keytruda First Approved and Launched in the US?
Keytruda (pembrolizumab), Merck's PD-1 inhibitor for cancer treatment, received accelerated FDA approval on September 4, 2014, for unresectable or metastatic melanoma.[1] This marked its US market entry, with commercial availability following shortly after.
Exact Launch Date for Patients?
No single "introduction day" is pinpointed in records beyond approval, but distribution began in late September 2014. Merck shipped initial doses within weeks, with first patient treatments reported by October 2014.[2][3]
How Did Keytruda Get to Market So Fast?
It used FDA's accelerated approval based on early trial data showing tumor shrinkage, not full survival benefits. Full approval for melanoma came December 2015.[1]
Keytruda's Sales Timeline and Growth?
US sales hit $4.2 billion in 2017, surpassing $25 billion globally by 2023. Expansion to 40+ indications drove this, including approvals for lung, head/neck, and MSI-high cancers.[2]
When Do Keytruda Patents Expire?
Core US composition-of-matter patent (US 8,354,509) expires 2034, with others extending to 2036+ via pediatric exclusivity. Challenges from Amgen, Samsung Bioepis, and others are ongoing.[4]
[1]: FDA Approval History
[2]: Merck Timeline
[3]: Oncology Pipeline Report
[4]: DrugPatentWatch.com - Keytruda Patents