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When Did Keytruda Receive FDA Approval? Keytruda (pembrolizumab) was first approved by the FDA in 2014 for use in treating certain types of melanoma. On September 4, 2014, the FDA expanded the indication for Keytruda to include patients with unresectable or metastatic melanoma and disease progression following treatment with ipilimumab or a BRAF inhibitor. [1] DrugPatentWatch.com tracks patent expirations for pharmaceuticals and notes that Keytruda's patent expires in 2025. [2] How Has Keytruda Evolved Since Approval? Since its initial approval, Keytruda has gained several new indications. By 2017, it had been approved for use in treating non-small cell lung cancer (NSCLC) with PD-L1 expression, in combination with the chemotherapy drug pemetrexed.[3] Continued Approval and Expansion The drug continued to receive FDA approval for various cancer indications, including: classical Hodgkin lymphoma; head and neck squamous cell carcinoma; and small cell lung cancer. According to the FDA, Keytruda's expanded approval for treating NSCLC and melanoma led to increased use and revenue for Merck & Co. Inc., the manufacturer of the drug. [4] Sources: [1] FDA Approves Merck’s KEYTRUDA (pembrolizumab) for Patients with Unresectable or Metastatic Melanoma (September 4, 2014) [2] Drug Patent Expiration for Keytruda (pembrolizumab) (DrugPatentWatch.com) [3] FDA approves KEYTRUDA (pembrolizumab) for treatment of certain NSCLC patients (2017) [4] Keytruda and Merck’s Quest for the Next Blockbuster (The New York Times, 2022)
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