{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T19:34:07Z","timestamp":1791401647085,"version":"4.3.3"},"reference-count":9,"publisher":"S. Karger AG","issue":"3-4","license":[{"start":{"date-parts":[[2010,1,1]],"date-time":"2010-01-01T00:00:00Z","timestamp":1262304000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.karger.com\/Services\/SiteLicenses"},{"start":{"date-parts":[[2010,1,1]],"date-time":"2010-01-01T00:00:00Z","timestamp":1262304000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.karger.com\/Services\/SiteLicenses"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Oncology"],"published-print":{"date-parts":[[2010]]},"abstract":"<i>Purpose:<\/i> On December 15, 2008, the US Food and Drug Administration approved plerixafor (Mozobil\u00ae; Genzyme Corp.), a new small-molecule inhibitor of the CXCR4 chemokine receptor, for use in combination with granulocyte colony-stimulating factor (G-CSF) to mobilize hematopoietic stem cells (HSC) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin\u2019s lymphoma (NHL) and multiple myeloma (MM). This summary reviews the database supporting this approval. <i>Experimental Design:<\/i> The safety and efficacy of plerixafor were demonstrated by 2 multicenter, randomized, placebo-controlled studies in patients with NHL and MM who were eligible for autologous HSC transplantation. The primary efficacy end points were the collection of \u22675 \u00d7 10<sup>6<\/sup> CD34+ cells\/kg from the peripheral blood in 4 or fewer apheresis sessions in patients with NHL or \u22676 \u00d7 10<sup>6<\/sup> CD34+ cells\/kg from the peripheral blood in 2 or fewer apheresis sessions in patients with MM. <i>Results:<\/i> The 2 randomized studies combined enrolled 600 patients (298 with NHL and 302 with MM). Fifty-nine percent of patients with NHL who were mobilized with G-CSF and plerixafor had peripheral blood HSC collections of \u22675 \u00d7 10<sup>6<\/sup> CD34+ cells\/kg in 4 or fewer apheresis sessions, compared with 20% of patients with NHL who were mobilized with G-CSF and placebo (p < 0.001). Seventy-two percent of patients with MM who were mobilized with Mozobil and G-CSF had peripheral blood HSC collections of \u22676 \u00d7 10<sup>6<\/sup> CD34+ cells\/kg in 2 or fewer apheresis sessions, compared with 34% of patients with MM who were mobilized with placebo and G-CSF (p < 0.001). Common adverse reactions included diarrhea, nausea, vomiting, flatulence, injection site reactions, fatigue, arthralgia, headache, dizziness, and insomnia. <i>Conclusions:<\/i> This report describes the Food and Drug Administration review supporting the approval of plerixafor.<\/jats:p>","DOI":"10.1159\/000315736","type":"journal-article","created":{"date-parts":[[2010,6,8]],"date-time":"2010-06-08T08:33:50Z","timestamp":1275986030000},"page":"282-288","source":"Crossref","is-referenced-by-count":117,"title":["FDA Review Summary: Mozobil in Combination with Granulocyte Colony-Stimulating Factor to Mobilize Hematopoietic Stem Cells to the Peripheral Blood for Collection and Subsequent Autologous Transplantation"],"prefix":"10.1159","volume":"78","author":[{"given":"Michael","family":"Brave","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ann","family":"Farrell","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sue","family":"Ching Lin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Terrance","family":"Ocheltree","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"Pope Miksinski","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shwu-Luan","family":"Lee","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haleh","family":"Saber","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeanne","family":"Fourie","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christoffer","family":"Tornoe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian","family":"Booth","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Weishi","family":"Yuan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kun","family":"He","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Justice","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard","family":"Pazdur","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"127","published-online":{"date-parts":[[2010,6,8]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","DOI":"10.1016%2FS0140-6736%2896%2990536-X"},{"key":"ref2","doi-asserted-by":"publisher","DOI":"10.1038%2Fsj.bmt.1703575"},{"key":"ref3","doi-asserted-by":"publisher","DOI":"10.1080%2F1042819031000067585"},{"key":"ref4","doi-asserted-by":"publisher","DOI":"10.1038%2Fsj.bmt.1705298"},{"key":"ref5","doi-asserted-by":"publisher","DOI":"10.1084%2Fjem.185.1.111"},{"key":"ref6","doi-asserted-by":"publisher","DOI":"10.1084%2Fjem.20041385"},{"key":"ref7","doi-asserted-by":"publisher","DOI":"10.1046%2Fj.1365-3148.1999.009001037.x"},{"key":"ref8","doi-asserted-by":"publisher","DOI":"10.1046%2Fj.1365-2141.2003.04157.x"},{"key":"ref9","doi-asserted-by":"publisher","DOI":"10.1038%2Fsj.bmt.1702038"}],"container-title":["Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.karger.com\/Article\/Pdf\/315736","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.karger.com\/Article\/Pdf\/315736","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,4,23]],"date-time":"2025-04-23T19:33:47Z","timestamp":1745436827000},"score":1,"resource":{"primary":{"URL":"https:\/\/karger.com\/article\/doi\/10.1159\/000315736"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2010]]},"references-count":9,"journal-issue":{"issue":"3-4","published-online":{"date-parts":[[2010,6,1]]}},"URL":"https:\/\/doi.org\/10.1159\/000315736","archive":["Portico"],"relation":{},"ISSN":["0030-2414","1423-0232"],"issn-type":[{"value":"0030-2414","type":"print"},{"value":"1423-0232","type":"electronic"}],"subject":[],"published":{"date-parts":[[2010]]}}}