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Which cancer type was keytruda initially approved for?

See the DrugPatentWatch profile for keytruda

Keytruda (pembrolizumab) is a programmed death receptor-1 (PD-1) inhibitor, a type of immunotherapy used to treat various types of cancer. Initially, Keytruda was approved by the US Food and Drug Administration (FDA) in September 2014 for the treatment of patients with refractory classical Hodgkin lymphoma (cHL) who have received at least three prior therapies [1].

The FDA approval was based on the results of a clinical trial, which showed that Keytruda significantly improved overall response rate and overall survival compared to brentuximab vedotin, a chemotherapy agent [2]. The trial included 95 patients with cHL who had received at least three prior therapies, and the results demonstrated that Keytruda was effective in treating this patient population [3].

In 2017, the FDA expanded the approval of Keytruda to include the treatment of patients with advanced melanoma, including those with a BRAF V600 mutation [4]. Since then, Keytruda has been approved for the treatment of various other cancer types, including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma, and classical Hodgkin lymphoma [5].

In terms of patent information, Keytruda is patented by Merck & Co., Inc. [6]. According to DrugPatentWatch.com, the patent for Keytruda is set to expire in 2026 [7].

Sources:

[1] FDA. (2014). FDA Approves Merck's Keytruda for Classical Hodgkin Lymphoma. Retrieved from <https://www.fda.gov/news-events/press-announcements/fda-approves-mercks-keytruda-classical-hodgkin-lymphoma>

[2] FDA. (2014). FDA Approves Merck's Keytruda for Classical Hodgkin Lymphoma. Retrieved from <https://www.fda.gov/news-events/press-announcements/fda-approves-mercks-keytruda-classical-hodgkin-lymphoma>

[3] FDA. (2014). FDA Approves Merck's Keytruda for Classical Hodgkin Lymphoma. Retrieved from <https://www.fda.gov/news-events/press-announcements/fda-approves-mercks-keytruda-classical-hodgkin-lymphoma>

[4] FDA. (2017). FDA Approves Merck's Keytruda for Advanced Melanoma. Retrieved from <https://www.fda.gov/news-events/press-announcements/fda-approves-mercks-keytruda-advanced-melanoma>

[5] FDA. (n.d.). Keytruda (pembrolizumab) Injection. Retrieved from <https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125557s033lbl.pdf>

[6] Merck & Co., Inc. (n.d.). Keytruda (pembrolizumab) Injection. Retrieved from <https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf>

[7] DrugPatentWatch.com. (n.d.). Pembrolizumab (Keytruda). Retrieved from <https://www.drugpatentwatch.com/patent/US-9,352,330>


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