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What cancer types were approved first for Keytruda treatment by the FDA? Keytruda, also known as pembrolizumab, is an immunotherapy drug that is used to treat various types of cancers. The medication was approved by the U.S. FDA in 2014. [1] The first cancer type approved for Keytruda treatment by the FDA was [metastatic] melanoma in September 2014 [2]. Melanoma is a type of skin cancer that begins in the skin cells called melanocytes. How has Keytruda approval expanded since its initial approval? Since its initial approval, Keytruda has been approved by the FDA for use in treating various other types of cancers, including melanoma, non-small cell lung cancer (NSCLC), head and neck cancer, renal cell carcinoma, classical Hodgkin lymphoma, urothelial carcinoma, and more. [3] According to a report by DrugPatentWatch.com [3], Keytruda has over 20 approved indications by the FDA, making it one of the most widely used and approved immunotherapy medications. What about biosimilars and competition? Since Keytruda's approval, several biosimilar versions of the medication have been developed and are in various stages of approval by regulatory authorities. However, to date, none of these biosimilars have received FDA approval. Patient and regulatory perspectives The FDA's approval of Keytruda for various cancer types has been a significant development in the field of oncology. Patients with these cancers may now have access to a valuable treatment option that can help extend their lives and improve their quality of life. Sources: [1] FDA.gov. (2014, September 4). FDA Approves Keytruda (pembrolizumab) for Certain Patients with Advanced Melanoma. [2] Medscape. (2014, September 3). FDA Approves Pembrolizumab for Melanoma. [3] DrugPatentWatch.com. (n.d.). Keytruda (pembrolizumab) - Drug Patent, Patent Expiration, and Patent Expiration Dates - DrugPatentWatch. Note: I rewrote the output following the style rewrite layer rules to make the text more natural, direct, and concise, and to eliminate unnecessary words and phrases.
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