Keytruda\u00a0(pembrolizumab) is a drug developed by\u00a0Merck\u00a0(or\u00a0MSD\u00a0outside of the U.S. and Canada). It has been approved by the U.S. Food and Drug Administration (FDA) and the European Commission for the treatment of a range of advanced cancers.<\/p>\n
Keytruda works\u00a0by aiding\u00a0the body\u2019s own immune system to fight and kill cancer cells.<\/p>\n
Normally, the immune system can detect and target an abnormal cell for destruction\u00a0using lymphocytes (white blood cells involved in the immune response) called\u00a0T-cells. However, to prevent the T-cells from attacking the body\u2019s own cells, the immune system has a series of\u00a0checkpoints. One of these checkpoints is the PD-1 pathway. Some tumor cells \u201chijack\u201d the pathway to hide from T-cells and escape being targeted. T-cells normally produce a receptor protein called programmed cell death 1\u00a0(PD-1), which\u00a0blocks killing a cell when it interacts with ligands (small molecules that, in this case, are attached to other cells) called PD-L1. Some tumor cells produce these ligands to evade T-cells.<\/p>\n
Keytruda is a monoclonal antibody designed to identify and block the PD-1 receptor. By blocking PD-1, the T-cells can \u201cfind\u201d and destroy the cancer cells. However, as Keytruda acts to remove an immune system checkpoint, it may also cause T-cells to attack healthy cells.<\/p>\n
Keytruda has been tested and continues to be tested in a wide range of clinical trials worldwide. These have been termed\u00a0Keynote\u00a0trials, and have been instrumental in gaining approval from the FDA and the European Commission.<\/p>\n
Keytruda received its first FDA approval \u2014 as a therapy for advanced or unresectable melanoma (a type of skin cancer) \u2014 on\u00a0Sept. 4, 2014, after key clinical trials demonstrated increased survival, tumor reduction, and reduced risk of disease progression in patients treated with Keytruda compared to those treated with a similar immunotherapy (Yervoy,\u00a0ipilimumab<\/a>).<\/p>\n Originally, Keytruda was to be prescribed following treatment with ipilimumab. \u00a0Then, on\u00a0\u00a0Dec. 18, 2015,\u00a0Keytruda was approved as a first-line treatment of melanoma on\u00a0\u00a0based on\u00a0results\u00a0of the Phase 3 KEYNOTE-006 (NCT01866319) trial, published in the\u00a0New England Journal of Medicine<\/em>. This drug\u00a0had previously been approved to treat advanced melanoma by the European Commission on\u00a0July 22, 2015.<\/p>\n The FDA approved Keytruda for the treatment of advanced non-small cell lung cancer (NSCLC) with high PD-L1 expression on\u00a0Oct. 24, 2016, expanding upon its\u00a0previous approval in 2015,\u00a0which required these patients to have failed to respond to other treatments first. Keytruda was likewise\u00a0approved for first-line use on NSCLC with high PD-L1 expression by the European Commission on\u00a0Jan. 31, 2017.<\/p>\n On\u00a0May 10, 2017, Keytruda was\u00a0granted accelerated approval by the FDA as a first-line combination therapy for metastatic non-squamous NSCLC regardless of PD-L1 status, based on the\u00a0results\u00a0of the KEYNOTE-021 Phase 1\/2 clinical trial (NCT02039674), published in\u00a0The Lancet Oncology<\/em>.<\/p>\n Keytruda\u00a0more\u00a0recently received FDA approval for the treatment of several other cancers. These include: recurrent or metastatic head and neck squamous cell carcinoma (approved on\u00a0Aug. 5 2016,\u00a0and on\u00a0Jan. 31, 2017, by the European Commission); refractory classical Hodgkin lymphoma (cHL) (approved on\u00a0March 15, 2017, and on\u00a0May 5, 2017, by the European Commission) and locally advanced metastatic urothelial carcinoma, or bladder cancer (approved on\u00a0May 18, 2017).<\/p>\n Keytruda is\u00a0under priority review\u00a0for FDA approval to treat\u00a0recurrent or advanced gastric or gastroesophageal junction adenocarcinoma.<\/p>\n On\u00a0May 23, 2017, the FDA granted Keytruda accelerated approval for the treatment of unresectable or metastatic solid tumors with a specific biomarker \u2014 microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). Accelerated approval\u00a0status means the FDA has approved the treatment for\u00a0marketing, but continued approval is\u00a0contingent on the results of ongoing clinical trials. The FDA aims to have made a final decision within the next six months, as part of Keytruda\u2019s\u00a0priority review for this indication. This decision\u00a0makes Keytruda\u00a0the first cancer treatment to be approved based on a genetic marker as opposed to the location in the body\u00a0where\u00a0a tumor originated.<\/p>\n <\/p>\n Source:\u00a0https:\/\/immuno-oncologynews.com\/keytruda-pembrolizumab\/<\/p>\n","protected":false},"excerpt":{"rendered":" Keytruda\u00a0(pembrolizumab) is a drug developed by\u00a0Merck\u00a0(or\u00a0MSD\u00a0outside of the U.S. and Canada). It has been approved by the U.S. Food and Drug Administration (FDA) and the European Commission for the treatment of aRead More…<\/a><\/p>\n","protected":false},"author":1,"featured_media":433,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,3],"tags":[7,5,6],"_links":{"self":[{"href":"https:\/\/www.creativebiolabs.net\/blog\/wp-json\/wp\/v2\/posts\/62"}],"collection":[{"href":"https:\/\/www.creativebiolabs.net\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.creativebiolabs.net\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.creativebiolabs.net\/blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.creativebiolabs.net\/blog\/wp-json\/wp\/v2\/comments?post=62"}],"version-history":[{"count":4,"href":"https:\/\/www.creativebiolabs.net\/blog\/wp-json\/wp\/v2\/posts\/62\/revisions"}],"predecessor-version":[{"id":434,"href":"https:\/\/www.creativebiolabs.net\/blog\/wp-json\/wp\/v2\/posts\/62\/revisions\/434"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.creativebiolabs.net\/blog\/wp-json\/wp\/v2\/media\/433"}],"wp:attachment":[{"href":"https:\/\/www.creativebiolabs.net\/blog\/wp-json\/wp\/v2\/media?parent=62"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.creativebiolabs.net\/blog\/wp-json\/wp\/v2\/categories?post=62"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.creativebiolabs.net\/blog\/wp-json\/wp\/v2\/tags?post=62"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}