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See the DrugPatentWatch profile for keytruda
Keytruda's FDA Approval Timeline Keytruda, also known as pembrolizumab, was approved by the US FDA on September 4, 2014, for the treatment of metastatic melanoma [1]. This approval marked a significant milestone in the development of immunotherapy for cancer treatment. Keytruda's Early Success Pembrolizumab's early success was built on the results of a phase 1 clinical trial, which showed promising response rates in patients with melanoma. The trial's findings paved the way for further investigations, ultimately leading to the FDA's accelerated approval of Keytruda [2]. Patent Expiration and Biosimilar Entry The patent for pembrolizumab is set to expire in 2026. This has led to various biosimilar developers working on rival versions of the treatment. However, the FDA will need to approve these biosimilars before they can enter the market. Sources: [1]: DrugPatentWatch.com (https://www.drugpatentwatch.com/drug/1458/pembrolizumab/) [2]: National Cancer Institute (https://cancer.gov/publications/dict/immotherapy-fact-sheet.pdf)
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