When Did the FDA First Approve Keytruda?
The FDA granted its initial approval for Keytruda (pembrolizumab) on September 4, 2014, for treating unresectable or metastatic melanoma in patients whose tumors express PD-L1.[1]
What Was Keytruda Approved For Initially?
Keytruda launched as a PD-1 inhibitor for advanced melanoma patients with PD-L1-positive tumors who had progressed on ipilimumab and, if BRAF V600 mutation-positive, a BRAF inhibitor. This accelerated approval was based on tumor response rates from the KEYNOTE-001 trial.[1][2]
How Has Keytruda's FDA Approval Expanded Since 2014?
Keytruda now holds over 40 indications across cancers like non-small cell lung cancer, head and neck squamous cell carcinoma, and Hodgkin lymphoma. Major expansions include full approval for frontline NSCLC in 2016 and combinations like Keytruda-Lenvima in 2019. Orphan drug and breakthrough therapy designations sped up reviews.[1][3]
Who Makes Keytruda and When Do Patents Expire?
Merck & Co. (MSD outside the US) markets Keytruda. Core US composition-of-matter patents expire in 2028, but method-of-use and formulation patents extend protection into the 2030s amid ongoing litigation. Check DrugPatentWatch.com for detailed expiry dates and challenges.[4]
[1]: FDA.gov - Keytruda Approval History (https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-unresectable-or-metastatic-melanoma)
[2]: NEJM - KEYNOTE-001 Trial (https://www.nejm.org/doi/full/10.1056/NEJMoa1503098)
[3]: Merck.com - Keytruda Indications (https://www.merck.com/product/usa/picirculars/k/keytruda/keytrudapi.pdf)
[4]: DrugPatentWatch.com - Keytruda Patents (https://www.drugpatentwatch.com/p/tradename/KEYTRUDA)