{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,27]],"date-time":"2026-10-27T03:30:20Z","timestamp":1793071820799,"version":"4.5.0"},"reference-count":24,"publisher":"Springer Science and Business Media LLC","issue":"17","license":[{"start":{"date-parts":[[2018,11,1]],"date-time":"2018-11-01T00:00:00Z","timestamp":1541030400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/www.springer.com\/tdm"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Drugs"],"published-print":{"date-parts":[[2018,11]]},"DOI":"10.1007\/s40265-018-1013-4","type":"journal-article","created":{"date-parts":[[2018,11,14]],"date-time":"2018-11-14T03:56:12Z","timestamp":1542167772000},"page":"1847-1853","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":130,"title":["Duvelisib: First Global Approval"],"prefix":"10.1007","volume":"78","author":[{"given":"Hannah A.","family":"Blair","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2018,11,14]]},"reference":[{"issue":"11","key":"1013_CR1","doi-asserted-by":"publisher","first-page":"1364","DOI":"10.1016\/j.chembiol.2013.09.017","volume":"20","author":"DG Winkler","year":"2013","unstructured":"Winkler DG, Faia KL, DiNitto JP, et al. PI3K-\u03b4 and PI3K-\u03b3 inhibition by IPI-145 abrogates immune responses and suppresses activity in autoimmune and inflammatory disease models. Chem Biol. 2013;20(11):1364\u201374.","journal-title":"Chem Biol"},{"issue":"5","key":"1013_CR2","doi-asserted-by":"publisher","first-page":"625","DOI":"10.1080\/13543784.2017.1312338","volume":"26","author":"HV Vangapandu","year":"2017","unstructured":"Vangapandu HV, Jain N, Gandhi V. Duvelisib: a phosphoinositide-3 kinase delta\/gamma inhibitor for chronic lymphocytic leukemia. Expert Opin Investig Drugs. 2017;26(5):625\u201332.","journal-title":"Expert Opin Investig Drugs"},{"key":"1013_CR3","unstructured":"US FDA. Duvelisib (COPIKTRA, Verastem, Inc.) for adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL); 2018. https:\/\/www.fda.gov\/Drugs\/InformationOnDrugs\/ApprovedDrugs\/ucm621503.htm . Accessed 10 Oct 2018."},{"key":"1013_CR4","unstructured":"Verastem Inc. Copiktra (duvelisib), capsules for oral use: US prescribing information; 2018. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/211155s000lbl.pdf . Accessed 10 Oct 2018."},{"key":"1013_CR5","unstructured":"Infinity Pharmaceuticals Inc. Infinity and Intellikine enter agreement to develop oral therapies targeting PI3 kinase delta, gamma [media release]; 8 Jul 2010. http:\/\/globenewswire.com\/news-release\/2010\/07\/08\/424597\/195928\/en\/Infinity-and-Intellikine-Enter-Agreement-to-Develop-Oral-Therapies-Targeting-PI3-Kinase-Delta-Gamma ."},{"key":"1013_CR6","unstructured":"Infinity Pharmaceuticals Inc. Infinity amends PI3K-delta, gamma agreement with Millennium [media release]; 24 Dec 2012. https:\/\/www.businesswire.com\/news\/home\/20121224005109\/en\/Infinity-Amends-PI3K-DeltaGamma-Agreement-Millennium ."},{"key":"1013_CR7","unstructured":"Infinity Pharmaceuticals. Infinity exercises option to buy out all future royalty obligations to Takeda for duvelisib sales in oncology [media release]; 31 Mar 2015. http:\/\/investors.infi.com\/news-releases\/news-release-details\/infinity-exercises-option-buy-out-all-future-royalty-obligations ."},{"key":"1013_CR8","unstructured":"Verastem. Verastem licenses duvelisib from Infinity Pharmaceuticals [media release]; 2 Nov 2016. http:\/\/investor.verastem.com\/phoenix.zhtml?c=250749&p=irol-newsArticle&ID=2218384 ."},{"key":"1013_CR9","unstructured":"Verastem Oncology. Verastem Oncology and Yakult Honsha Co., Ltd. sign exclusive license agreement for the development and commercialization of duvelisib in Japan [media release]; 5 June 2018. http:\/\/investor.verastem.com\/phoenix.zhtml?c=250749&p=irol-newsArticle&ID=2353165 ."},{"key":"1013_CR10","unstructured":"Verastem Inc. CSPC Pharmaceutical Group Limited and Verastem Oncology sign exclusive license agreement for the development and commercialization of COPIKTRA\u2122 (duvelisib) in China [media release]; 25 Sep 2018. http:\/\/investor.verastem.com\/phoenix.zhtml?c=250749&p=irol-newsArticle&ID=2368922 ."},{"issue":"8","key":"1013_CR11","doi-asserted-by":"publisher","first-page":"888","DOI":"10.1182\/blood-2017-08-802470","volume":"131","author":"SM Horwitz","year":"2018","unstructured":"Horwitz SM, Koch R, Porcu P, et al. Activity of the PI3K-\u03b4, \u03b3 inhibitor duvelisib in a phase 1 trial and preclinical models of T-cell lymphoma. Blood. 2018;131(8):888\u201398.","journal-title":"Blood."},{"issue":"8","key":"1013_CR12","doi-asserted-by":"publisher","first-page":"877","DOI":"10.1182\/blood-2017-05-786566","volume":"131","author":"IW Flinn","year":"2018","unstructured":"Flinn IW, O\u2019Brien S, Kahl B, et al. Duvelisib, a novel oral dual inhibitor of PI3K-\u03b4, \u03b3, is clinically active in advanced hematologic malignancies. Blood. 2018;131(8):877\u201387.","journal-title":"Blood"},{"issue":"9","key":"1013_CR13","doi-asserted-by":"publisher","first-page":"1811","DOI":"10.1038\/leu.2015.105","volume":"29","author":"K Balakrishnan","year":"2015","unstructured":"Balakrishnan K, Peluso M, Fu M, et al. The phosphoinositide-3-kinase (PI3K)-delta and gamma inhibitor, IPI-145 (duvelisib), overcomes signals from the PI3K\/AKT\/S6 pathway and promotes apoptosis in CLL. Leukemia. 2015;29(9):1811\u201322.","journal-title":"Leukemia"},{"issue":"24","key":"1013_CR14","doi-asserted-by":"publisher","first-page":"3583","DOI":"10.1182\/blood-2014-07-587279","volume":"124","author":"S Dong","year":"2014","unstructured":"Dong S, Guinn D, Dubovsky JA, et al. IPI-145 antagonizes intrinsic and extrinsic survival signals in chronic lymphocytic leukemia cells. Blood. 2014;124(24):3583\u20136.","journal-title":"Blood"},{"issue":"Suppl 1","key":"1013_CR15","first-page":"363","volume":"100","author":"G Pillinger","year":"2015","unstructured":"Pillinger G, Piddock R, Lawes M, et al. The PI3K gamma\/delta inhibitor, IPI-145 (duvelisib) inhibits acute myeloid leukemia blast proliferation and adhesion [abstract no. E911]. Haematologica. 2015;100(Suppl 1):363.","journal-title":"Haematologica"},{"key":"1013_CR16","doi-asserted-by":"crossref","unstructured":"Weaver DT, Sprott K, Pachter J, et al. Duvelisib inhibition of chemokines in patients with CLL (DUO study) and iNHL (DYNAMO study) [abstract no. 12048]. J Clin Oncol. 2018;36(Suppl 15).","DOI":"10.1200\/JCO.2018.36.15_suppl.12048"},{"issue":"Suppl 1","key":"1013_CR17","first-page":"14","volume":"5","author":"J Kharidia","year":"2016","unstructured":"Kharidia J, Van Iersel MP, Hartstra J, et al. The pharmacokinetics, pharmacodynamics, safety, tolerability and food effect of duvelisib, an oral, dual PI3K-\u03b4 and PI3K-\u03b3 inhibitor, in healthy human subjects [abstract no. 020]. Clin Pharmacol Drug Dev. 2016;5(Suppl 1):14\u20135.","journal-title":"Clin Pharmacol Drug Dev"},{"key":"1013_CR18","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2018-05-850461","author":"IW Flinn","year":"2018","unstructured":"Flinn IW, Hillmen P, Montillo M, et al. The phase 3 DUO trial: duvelisib versus ofatumumab in relapsed and refractory CLL\/SLL. Blood. 2018. https:\/\/doi.org\/10.1182\/blood-2018-05-850461 .","journal-title":"Blood"},{"key":"1013_CR19","doi-asserted-by":"crossref","unstructured":"Kuss BJ, Davids MS, Hillmen P, et al. The efficacy of duvelisib monotherapy following disease progression on ofatumumab monotherapy in patients with relapsed\/refractory CLL or SLL in the DUO crossover extension study [abstract no. 7533 plus poster]. J Clin Oncol. 2018;36(Suppl 15).","DOI":"10.1200\/JCO.2018.36.15_suppl.7533"},{"key":"1013_CR20","doi-asserted-by":"crossref","unstructured":"Flinn IW, Miller CB, Ardeshna KM, et al. DYNAMO: a phase 2 study demonstrating the clinical activity of duvelisib in patients with relapsed refractory indolent non-Hodgkin lymphoma [abstract no. 1218]. Blood 2016;128(22).","DOI":"10.1182\/blood.V128.22.1218.1218"},{"key":"1013_CR21","unstructured":"Davids M, Fisher D, Tyekucheva S, et al. A phase Ib\/II study of duvelisib in combination with FCR (DFCR) for frontline therapy of younger CLL patients [abstract no. S807]. In: 23rd Congress of the European Haematology Association; 2018."},{"key":"1013_CR22","doi-asserted-by":"crossref","unstructured":"Flinn IW, Cherry M, Maris M, et al. Combination trial of duvelisib (IPI-145) with bendamustine, rituximab, or bendamustine\/rituximab in patients with lymphoma or chronic lymphocytic leukemia [abstract no. 3928]. Blood. 2015;126(23).","DOI":"10.1182\/blood.V126.23.3928.3928"},{"issue":"(Suppl 1)","key":"1013_CR23","first-page":"104","volume":"101","author":"C Casulo","year":"2016","unstructured":"Casulo C, Jacobsen E, Van Eygen K, et al. Preliminary safety, pharmacokinetics, and pharmacodynamics of duvelisib plus rituximab or obinutuzumab in patients with previously untreated CD20+ follicular lymphoma [abstract no. P319]. Haematologica. 2016;101((Suppl 1)):104.","journal-title":"Haematologica."},{"key":"1013_CR24","doi-asserted-by":"crossref","unstructured":"Horwitz SM, Soto J, Youssoufian H. The PRIMO study: a phase 2 study of duvelisib efficacy and safety in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) [abstract no. TPS7590]. J Clin Oncol. 2018;36(Suppl 15).","DOI":"10.1200\/JCO.2018.36.15_suppl.TPS7590"}],"container-title":["Drugs"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/link.springer.com\/article\/10.1007\/s40265-018-1013-4\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1007\/s40265-018-1013-4.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1007\/s40265-018-1013-4.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2020,11,15]],"date-time":"2020-11-15T05:33:48Z","timestamp":1605418428000},"score":1,"resource":{"primary":{"URL":"http:\/\/link.springer.com\/10.1007\/s40265-018-1013-4"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,11]]},"references-count":24,"journal-issue":{"issue":"17","published-print":{"date-parts":[[2018,11]]}},"alternative-id":["1013"],"URL":"https:\/\/doi.org\/10.1007\/s40265-018-1013-4","relation":{},"ISSN":["0012-6667","1179-1950"],"issn-type":[{"value":"0012-6667","type":"print"},{"value":"1179-1950","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,11]]},"assertion":[{"value":"14 November 2018","order":1,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Compliance with Ethical Standards"}},{"value":"The preparation of this review was not supported by any external funding.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"During the peer review process the manufacturer of duvelisib was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the author on the basis of scientific completeness and accuracy. Hannah Blair is a salaried employee of Adis\/Springer, is responsible for the article content and declares no relevant conflicts of interest.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of interest"}}]}}