{"id":2139,"date":"2017-05-24T17:00:22","date_gmt":"2017-05-24T11:30:22","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=2139"},"modified":"2021-10-12T11:33:05","modified_gmt":"2021-10-12T06:03:05","slug":"the-snippet-fda-grants-accelerated-approval-to-pembrolizumab","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/the-snippet-fda-grants-accelerated-approval-to-pembrolizumab","title":{"rendered":"FDA grants accelerated approval to pembrolizumab"},"content":{"rendered":"<p style=\"text-align: justify;\">The U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA, Merck &amp; Co.) for adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options or with MSI-H or dMMR colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This is the FDA\u2019s first tissue\/site-agnostic approval. The approval was based on data from 149 patients with MSI-H or dMMR cancers enrolled across five uncontrolled, multi-cohort, multi-center, single-arm clinical trials. The major efficacy outcome measures were objective response rate (ORR) assessed by blinded independent central radiologists\u2019 review according to RECIST 1.1, and response duration. ORR was 39.6% (95% CI: 31.7, 47.9). Responses lasted six months or more for 78% percent of those who responded to pembrolizumab. There were 11 complete responses and 48 partial responses. ORR was similar irrespective of whether patients were diagnosed with CRC (36%) or a different cancer type (46% across the 14 other cancer types). The recommended pembrolizumab dose for this indication is 200 mg for adults or 2 mg\/kg (up to a maximum of 200 mg) for children, administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.<\/p>\n<p style=\"text-align: justify;\">To read more, click <a href=\"https:\/\/www.fda.gov\/Drugs\/InformationOnDrugs\/ApprovedDrugs\/ucm560040.htm\">FDA approval to pembrolizumab<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA, Merck &amp; Co.) for adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options or with MSI-H or dMMR colorectal cancer [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":2140,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[17434,41],"tags":[904,137,906,174,345,905,595],"industry":[17225],"therapeutic_areas":[17228],"class_list":["post-2139","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-facts-and-figures","category-snippets","tag-accelerated-approval","tag-cancer","tag-cancer-therapies","tag-colorectal-cancer","tag-keytruda","tag-pembrolizumab","tag-usfda","industry-pharmaceutical","therapeutic_areas-oncology"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.8 (Yoast SEO v25.8) - 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href=\"https:\/\/www.delveinsight.com\/blog\/facts-and-figures\/\" class=\"advgb-post-tax-term\">Facts and Figures<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/snippets\/\" class=\"advgb-post-tax-term\">Snippets - A Small piece of News or Article<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Facts and Figures<\/span>","<span class=\"advgb-post-tax-term\">Snippets - A Small piece of News or Article<\/span>"]},"tags":{"linked":["<a href=\"https:\/\/www.delveinsight.com\/blog\/snippets\/\" class=\"advgb-post-tax-term\">Accelerated approval<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/snippets\/\" class=\"advgb-post-tax-term\">Cancer<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/snippets\/\" class=\"advgb-post-tax-term\">Cancer therapies<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/snippets\/\" class=\"advgb-post-tax-term\">Colorectal Cancer<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/snippets\/\" 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