{"product_id":"nda-216059-s-001-jaypirca-pirtobrutinib-fda-approval-package-cll-sll-supplemental-approval","title":"NDA 216059\/S-001 — Jaypirca (pirtobrutinib) FDA Approval Package -- CLL\/SLL Supplemental Approval","description":"\u003cp data-start=\"297\" data-end=\"740\"\u003eThis FDA approval package contains the agency's complete multidisciplinary review supporting the supplemental approval of \u003cstrong data-start=\"419\" data-end=\"447\"\u003eJaypirca (pirtobrutinib)\u003c\/strong\u003e for the treatment of \u003cstrong data-start=\"469\" data-end=\"507\"\u003echronic lymphocytic leukemia (CLL)\u003c\/strong\u003e and \u003cstrong data-start=\"512\" data-end=\"548\"\u003esmall lymphocytic lymphoma (SLL)\u003c\/strong\u003e. The release includes FDA's scientific, clinical, statistical, pharmacology, and regulatory evaluations, documenting how the agency assessed the application and reached its approval decision.\u003c\/p\u003e\n\u003ch2 data-section-id=\"1tdxqw8\" data-start=\"747\" data-end=\"766\"\u003eDocument Details\u003c\/h2\u003e\n\u003cdiv class=\"TyagGW_tableContainer\"\u003e\n\u003cdiv class=\"group TyagGW_tableWrapper flex flex-col-reverse w-fit\" tabindex=\"-1\"\u003e\n\u003ctable data-start=\"768\" data-end=\"1122\" class=\"w-fit min-w-(--thread-content-width)\"\u003e\n\u003cthead data-start=\"768\" data-end=\"773\"\u003e\n\u003ctr data-start=\"768\" data-end=\"773\"\u003e\n\u003cth data-start=\"768\" data-end=\"770\" data-col-size=\"sm\" class=\"last:pe-10\"\u003e\u003c\/th\u003e\n\u003cth data-start=\"770\" data-end=\"773\" data-col-size=\"sm\" class=\"last:pe-10\"\u003e\u003c\/th\u003e\n\u003c\/tr\u003e\n\u003c\/thead\u003e\n\u003ctbody data-start=\"784\" data-end=\"1122\"\u003e\n\u003ctr data-start=\"784\" data-end=\"809\"\u003e\n\u003ctd data-start=\"784\" data-end=\"801\" data-col-size=\"sm\"\u003e\u003cstrong data-start=\"786\" data-end=\"800\"\u003eFDA Center\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd data-start=\"801\" data-end=\"809\" data-col-size=\"sm\"\u003eCDER\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr data-start=\"810\" data-end=\"848\"\u003e\n\u003ctd data-start=\"810\" data-end=\"828\" data-col-size=\"sm\"\u003e\u003cstrong data-start=\"812\" data-end=\"827\"\u003eApplication\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd data-col-size=\"sm\" data-start=\"828\" data-end=\"848\"\u003eNDA 216059\/S-001\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr data-start=\"849\" data-end=\"888\"\u003e\n\u003ctd data-start=\"849\" data-end=\"865\" data-col-size=\"sm\"\u003e\u003cstrong data-start=\"851\" data-end=\"864\"\u003eApplicant\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd data-col-size=\"sm\" data-start=\"865\" data-end=\"888\"\u003eLoxo Oncology, Inc.\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr data-start=\"889\" data-end=\"915\"\u003e\n\u003ctd data-start=\"889\" data-end=\"903\" data-col-size=\"sm\"\u003e\u003cstrong data-start=\"891\" data-end=\"902\"\u003eProduct\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd data-col-size=\"sm\" data-start=\"903\" data-end=\"915\"\u003eJaypirca\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr data-start=\"916\" data-end=\"952\"\u003e\n\u003ctd data-start=\"916\" data-end=\"935\" data-col-size=\"sm\"\u003e\u003cstrong data-start=\"918\" data-end=\"934\"\u003eGeneric Name\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd data-col-size=\"sm\" data-start=\"935\" data-end=\"952\"\u003epirtobrutinib\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr data-start=\"953\" data-end=\"993\"\u003e\n\u003ctd data-start=\"953\" data-end=\"973\" data-col-size=\"sm\"\u003e\u003cstrong data-start=\"955\" data-end=\"972\"\u003eApproval Date\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd data-col-size=\"sm\" data-start=\"973\" data-end=\"993\"\u003eDecember 1, 2023\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr data-start=\"994\" data-end=\"1029\"\u003e\n\u003ctd data-start=\"994\" data-end=\"1016\" data-col-size=\"sm\"\u003e\u003cstrong data-start=\"996\" data-end=\"1015\"\u003eDocument Length\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd data-col-size=\"sm\" data-start=\"1016\" data-end=\"1029\"\u003e290 pages\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr data-start=\"1030\" data-end=\"1066\"\u003e\n\u003ctd data-start=\"1030\" data-end=\"1048\" data-col-size=\"sm\"\u003e\u003cstrong data-start=\"1032\" data-end=\"1047\"\u003eFile Format\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd data-col-size=\"sm\" data-start=\"1048\" data-end=\"1066\"\u003eSearchable PDF\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr data-start=\"1067\" data-end=\"1122\"\u003e\n\u003ctd data-start=\"1067\" data-end=\"1086\" data-col-size=\"sm\"\u003e\u003cstrong data-start=\"1069\" data-end=\"1085\"\u003eAvailability\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd data-col-size=\"sm\" data-start=\"1086\" data-end=\"1122\"\u003eAvailable for immediate download\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003ch2 data-section-id=\"hiily6\" data-start=\"1129\" data-end=\"1147\"\u003e\u003c\/h2\u003e\n\u003ch2 data-section-id=\"hiily6\" data-start=\"1129\" data-end=\"1147\"\u003eRedaction Level\u003c\/h2\u003e\n\u003cp data-start=\"1149\" data-end=\"1188\"\u003e\u003cstrong data-start=\"1149\" data-end=\"1188\"\u003eLight redaction (approximately 3%).\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp data-start=\"1190\" data-end=\"1528\"\u003eRedactions are limited primarily to proprietary commercial information, selected regulatory correspondence, bioanalytical methods, and operational details. FDA's approval rationale, clinical and safety reviews, benefit-risk assessment, inspection findings, labeling decisions, and postmarketing requirements remain substantially readable.\u003c\/p\u003e\n\u003ch2 data-section-id=\"w3a6bn\" data-start=\"1535\" data-end=\"1553\"\u003eWhat's Included\u003c\/h2\u003e\n\u003cul data-start=\"1555\" data-end=\"2040\"\u003e\n\u003cli data-section-id=\"w5to5u\" data-start=\"1555\" data-end=\"1576\"\u003eFDA approval letter\u003c\/li\u003e\n\u003cli data-section-id=\"cy976u\" data-start=\"1577\" data-end=\"1608\"\u003eFinal prescribing information\u003c\/li\u003e\n\u003cli data-section-id=\"1pi992q\" data-start=\"1609\" data-end=\"1643\"\u003eFDA-approved patient information\u003c\/li\u003e\n\u003cli data-section-id=\"wp9voe\" data-start=\"1644\" data-end=\"1670\"\u003eMultidisciplinary review\u003c\/li\u003e\n\u003cli data-section-id=\"1x1w65j\" data-start=\"1671\" data-end=\"1696\"\u003eBenefit-risk assessment\u003c\/li\u003e\n\u003cli data-section-id=\"x6u5jd\" data-start=\"1697\" data-end=\"1723\"\u003eClinical efficacy review\u003c\/li\u003e\n\u003cli data-section-id=\"skjkpl\" data-start=\"1724\" data-end=\"1750\"\u003eIntegrated safety review\u003c\/li\u003e\n\u003cli data-section-id=\"10yru1\" data-start=\"1751\" data-end=\"1771\"\u003eStatistical review\u003c\/li\u003e\n\u003cli data-section-id=\"ihj697\" data-start=\"1772\" data-end=\"1802\"\u003eClinical pharmacology review\u003c\/li\u003e\n\u003cli data-section-id=\"ldkqx9\" data-start=\"1803\" data-end=\"1840\"\u003ePopulation pharmacokinetic analysis\u003c\/li\u003e\n\u003cli data-section-id=\"oytgt6\" data-start=\"1841\" data-end=\"1869\"\u003eExposure-response modeling\u003c\/li\u003e\n\u003cli data-section-id=\"lwb75g\" data-start=\"1870\" data-end=\"1918\"\u003eNonclinical pharmacology and toxicology review\u003c\/li\u003e\n\u003cli data-section-id=\"1c4976d\" data-start=\"1919\" data-end=\"1948\"\u003eClinical inspection summary\u003c\/li\u003e\n\u003cli data-section-id=\"4n4a9z\" data-start=\"1949\" data-end=\"1974\"\u003ePatient labeling review\u003c\/li\u003e\n\u003cli data-section-id=\"n8zg7r\" data-start=\"1975\" data-end=\"2011\"\u003eMedication error prevention review\u003c\/li\u003e\n\u003cli data-section-id=\"1d61y0o\" data-start=\"2012\" data-end=\"2040\"\u003ePostmarketing requirements\u003c\/li\u003e\n\u003c\/ul\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51408883384484,"sku":"FDANDA216059\/S-01","price":667.61,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/FDANDA216059_S-01.png?v=1784674454","url":"https:\/\/foiadocs.com\/products\/nda-216059-s-001-jaypirca-pirtobrutinib-fda-approval-package-cll-sll-supplemental-approval","provider":"FOIA Document Source","version":"1.0","type":"link"}