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See the DrugPatentWatch profile for keytruda
What cancer did Keytruda first target? Keytruda received its first FDA approval in 2014 for advanced melanoma that could not be removed by surgery. [1] At launch, the drug was indicated only for patients whose tumors tested positive for PD-L1 expression or who had progressed after ipilimumab, or after a BRAF inhibitor if the tumor carried a BRAF mutation. [1] When did the label expand beyond melanoma? The FDA added metastatic non-small cell lung cancer in 2015, followed by head and neck squamous cell carcinoma in 2016. [2] By 2017 the indication broadened to any solid tumor with microsatellite instability-high or mismatch repair deficient status, marking the first tissue-agnostic approval. [2] How does Keytruda’s early use compare with Opdivo? Opdivo also won its initial approval for melanoma in late 2014, but its label included both previously treated and untreated patients from day one. [3] Keytruda’s first label was narrower, focusing on a PD-L1 selected population. [1] Which companies challenged the early patents? Merck’s core patents covering the PD-1 antibody sequence and use in cancer faced inter-partes review petitions from Bristol-Myers Squibb and Pfizer. [4] The challenges centered on obviousness and written-description issues but did not block FDA approval or initial marketing. [4] When does Keytruda’s primary U.S. patent expire? The main composition-of-matter patent listed in the Orange Book for pembrolizumab is set to expire in 2028, with some method-of-use patents extending to 2032. [5] Biosimilar developers are already preparing filings ahead of these dates. [1] https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-treatment-advanced-melanoma [2] https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-expanded-indications-pembrolizumab [3] https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-treatment-advanced-melanoma [4] https://www.drugpatentwatch.com/drug/pembrolizumab [5] https://www.drugpatentwatch.com/drug/pembrolizumab
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