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Items: 50

1.

FDA Approval Summary: Tagraxofusp-erzs For Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm.

Jen EY, Gao X, Li L, Zhuang L, Simpson NE, Aryal B, Wang R, Przepiorka D, Shen YL, Leong R, Liu C, Sheth CM, Bowen S, Goldberg KB, Farrell AT, Blumenthal GM, Pazdur R.

Clin Cancer Res. 2019 Sep 23. pii: clincanres.2329.2019. doi: 10.1158/1078-0432.CCR-19-2329. [Epub ahead of print]

PMID:
31548341
2.

FDA Approval Summary: Mogamulizumab-kpkc for Mycosis Fungoides and S├ęzary Syndrome.

Kasamon YL, Chen H, de Claro RA, Nie L, Ye J, Blumenthal GM, Farrell AT, Pazdur R.

Clin Cancer Res. 2019 Jul 31. doi: 10.1158/1078-0432.CCR-19-2030. [Epub ahead of print]

PMID:
31366601
3.

FDA Approval Summary: Glasdegib for Newly Diagnosed Acute Myeloid Leukemia.

Norsworthy KJ, By K, Subramaniam S, Zhuang L, Del Valle PL, Przepiorka D, Shen YL, Sheth CM, Liu C, Leong R, Goldberg KB, Farrell AT, Pazdur R.

Clin Cancer Res. 2019 Oct 15;25(20):6021-6025. doi: 10.1158/1078-0432.CCR-19-0365. Epub 2019 May 7.

PMID:
31064779
4.

FDA Approval Summary: Brentuximab Vedotin in First-Line Treatment of Peripheral T-Cell Lymphoma.

Richardson NC, Kasamon YL, Chen H, de Claro RA, Ye J, Blumenthal GM, Farrell AT, Pazdur R.

Oncologist. 2019 May;24(5):e180-e187. doi: 10.1634/theoncologist.2019-0098. Epub 2019 Mar 26.

5.

FDA Approval Summary: Ivosidenib for Relapsed or Refractory Acute Myeloid Leukemia with an Isocitrate Dehydrogenase-1 Mutation.

Norsworthy KJ, Luo L, Hsu V, Gudi R, Dorff SE, Przepiorka D, Deisseroth A, Shen YL, Sheth CM, Charlab R, Williams GM, Goldberg KB, Farrell AT, Pazdur R.

Clin Cancer Res. 2019 Jun 1;25(11):3205-3209. doi: 10.1158/1078-0432.CCR-18-3749. Epub 2019 Jan 28.

PMID:
30692099
6.

FDA Approval Summary: (Daunorubicin and Cytarabine) Liposome for Injection for the Treatment of Adults with High-Risk Acute Myeloid Leukemia.

Krauss AC, Gao X, Li L, Manning ML, Patel P, Fu W, Janoria KG, Gieser G, Bateman DA, Przepiorka D, Shen YL, Shord SS, Sheth CM, Banerjee A, Liu J, Goldberg KB, Farrell AT, Blumenthal GM, Pazdur R.

Clin Cancer Res. 2019 May 1;25(9):2685-2690. doi: 10.1158/1078-0432.CCR-18-2990. Epub 2018 Dec 12.

PMID:
30541745
7.

FDA Approval: Blinatumomab for Patients with B-cell Precursor Acute Lymphoblastic Leukemia in Morphologic Remission with Minimal Residual Disease.

Jen EY, Xu Q, Schetter A, Przepiorka D, Shen YL, Roscoe D, Sridhara R, Deisseroth A, Philip R, Farrell AT, Pazdur R.

Clin Cancer Res. 2019 Jan 15;25(2):473-477. doi: 10.1158/1078-0432.CCR-18-2337. Epub 2018 Sep 25.

PMID:
30254079
8.

FDA Approval Summary: Midostaurin for the Treatment of Advanced Systemic Mastocytosis.

Kasamon YL, Ko CW, Subramaniam S, Ma L, Yang Y, Nie L, Shord S, Przepiorka D, Farrell AT, McKee AE, Pazdur R.

Oncologist. 2018 Dec;23(12):1511-1519. doi: 10.1634/theoncologist.2018-0222. Epub 2018 Aug 16.

9.

FDA Supplemental Approval: Blinatumomab for Treatment of Relapsed and Refractory Precursor B-Cell Acute Lymphoblastic Leukemia.

Pulte ED, Vallejo J, Przepiorka D, Nie L, Farrell AT, Goldberg KB, McKee AE, Pazdur R.

Oncologist. 2018 Nov;23(11):1366-1371. doi: 10.1634/theoncologist.2018-0179. Epub 2018 Jul 17.

10.

FDA Approval Summary: Mylotarg for Treatment of Patients with Relapsed or Refractory CD33-Positive Acute Myeloid Leukemia.

Norsworthy KJ, Ko CW, Lee JE, Liu J, John CS, Przepiorka D, Farrell AT, Pazdur R.

Oncologist. 2018 Sep;23(9):1103-1108. doi: 10.1634/theoncologist.2017-0604. Epub 2018 Apr 12.

11.

FDA Approval Summary: Tocilizumab for Treatment of Chimeric Antigen Receptor T Cell-Induced Severe or Life-Threatening Cytokine Release Syndrome.

Le RQ, Li L, Yuan W, Shord SS, Nie L, Habtemariam BA, Przepiorka D, Farrell AT, Pazdur R.

Oncologist. 2018 Aug;23(8):943-947. doi: 10.1634/theoncologist.2018-0028. Epub 2018 Apr 5.

12.

A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics: A Review.

Beaver JA, Howie LJ, Pelosof L, Kim T, Liu J, Goldberg KB, Sridhara R, Blumenthal GM, Farrell AT, Keegan P, Pazdur R, Kluetz PG.

JAMA Oncol. 2018 Jun 1;4(6):849-856. doi: 10.1001/jamaoncol.2017.5618. Review.

PMID:
29494733
13.

FDA Approval: Gemtuzumab Ozogamicin for the Treatment of Adults with Newly Diagnosed CD33-Positive Acute Myeloid Leukemia.

Jen EY, Ko CW, Lee JE, Del Valle PL, Aydanian A, Jewell C, Norsworthy KJ, Przepiorka D, Nie L, Liu J, Sheth CM, Shapiro M, Farrell AT, Pazdur R.

Clin Cancer Res. 2018 Jul 15;24(14):3242-3246. doi: 10.1158/1078-0432.CCR-17-3179. Epub 2018 Feb 23.

14.

FDA Approval Summary: Lenalidomide as Maintenance Therapy After Autologous Stem Cell Transplant in Newly Diagnosed Multiple Myeloma.

Pulte ED, Dmytrijuk A, Nie L, Goldberg KB, McKee AE, Farrell AT, Pazdur R.

Oncologist. 2018 Jun;23(6):734-739. doi: 10.1634/theoncologist.2017-0440. Epub 2018 Feb 7.

15.

Quantitative Relationship Between AUEC of Absolute Neutrophil Count and Duration of Severe Neutropenia for G-CSF in Breast Cancer Patients.

Li L, Ma L, Schrieber SJ, Rahman NA, Deisseroth A, Farrell AT, Wang Y, Sinha V, Marathe A.

Clin Pharmacol Ther. 2018 Oct;104(4):742-748. doi: 10.1002/cpt.991. Epub 2018 Feb 2.

PMID:
29392707
16.

FDA Approval Summary: Daratumumab for Treatment of Multiple Myeloma After One Prior Therapy.

Bhatnagar V, Gormley NJ, Luo L, Shen YL, Sridhara R, Subramaniam S, Shen G, Ma L, Shord S, Goldberg KB, Farrell AT, McKee AE, Pazdur R.

Oncologist. 2017 Nov;22(11):1347-1353. doi: 10.1634/theoncologist.2017-0229. Epub 2017 Sep 13.

17.

Flexibility and innovation in the FDA's novel regulatory approval strategies for hematologic drugs.

Farrell AT, Goldberg KB, Pazdur R.

Blood. 2017 Sep 14;130(11):1285-1289. doi: 10.1182/blood-2017-04-742726. Epub 2017 Aug 3. No abstract available. Erratum in: Blood. 2018 Apr 19;131(16):1875-1876.

18.

U.S. Food and Drug Administration approval summary: Eltrombopag for the treatment of pediatric patients with chronic immune (idiopathic) thrombocytopenia.

Ehrlich LA, Kwitkowski VE, Reaman G, Ko CW, Nie L, Pazdur R, Farrell AT.

Pediatr Blood Cancer. 2017 Dec;64(12). doi: 10.1002/pbc.26657. Epub 2017 Jun 19.

PMID:
28627134
19.

FDA Approval Summary: Nivolumab for the Treatment of Relapsed or Progressive Classical Hodgkin Lymphoma.

Kasamon YL, de Claro RA, Wang Y, Shen YL, Farrell AT, Pazdur R.

Oncologist. 2017 May;22(5):585-591. doi: 10.1634/theoncologist.2017-0004. Epub 2017 Apr 24.

20.

The Role of Minimal Residual Disease Testing in Myeloma Treatment Selection and Drug Development: Current Value and Future Applications.

Anderson KC, Auclair D, Kelloff GJ, Sigman CC, Avet-Loiseau H, Farrell AT, Gormley NJ, Kumar SK, Landgren O, Munshi NC, Cavo M, Davies FE, Di Bacco A, Dickey JS, Gutman SI, Higley HR, Hussein MA, Jessup JM, Kirsch IR, Little RF, Loberg RD, Lohr JG, Mukundan L, Omel JL, Pugh TJ, Reaman GH, Robbins MD, Sasser AK, Valente N, Zamagni E.

Clin Cancer Res. 2017 Aug 1;23(15):3980-3993. doi: 10.1158/1078-0432.CCR-16-2895. Epub 2017 Apr 20.

21.

FDA Drug Approval: Elotuzumab in Combination with Lenalidomide and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma.

Gormley NJ, Ko CW, Deisseroth A, Nie L, Kaminskas E, Kormanik N, Goldberg KB, Farrell AT, Pazdur R.

Clin Cancer Res. 2017 Nov 15;23(22):6759-6763. doi: 10.1158/1078-0432.CCR-16-2870. Epub 2017 Mar 1.

22.

Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials-Response.

Kluetz PG, Papadopoulos EJ, Johnson LL, Donoghue M, Kwitkowski VE, Chen WH, Sridhara R, Farrell AT, Keegan P, Kim G, Pazdur R.

Clin Cancer Res. 2016 Nov 15;22(22):5618. doi: 10.1158/1078-0432.CCR-16-2140. No abstract available.

23.

Minimal Residual Disease as a Potential Surrogate End Point-Lingering Questions.

Gormley NJ, Farrell AT, Pazdur R.

JAMA Oncol. 2017 Jan 1;3(1):18-20. doi: 10.1001/jamaoncol.2016.3112. No abstract available.

PMID:
27632052
24.

Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials: Symptomatic Adverse Events, Physical Function, and Disease-Related Symptoms.

Kluetz PG, Slagle A, Papadopoulos EJ, Johnson LL, Donoghue M, Kwitkowski VE, Chen WH, Sridhara R, Farrell AT, Keegan P, Kim G, Pazdur R.

Clin Cancer Res. 2016 Apr 1;22(7):1553-8. doi: 10.1158/1078-0432.CCR-15-2035. Epub 2016 Jan 12.

25.

FDA Approval: Blinatumomab.

Przepiorka D, Ko CW, Deisseroth A, Yancey CL, Candau-Chacon R, Chiu HJ, Gehrke BJ, Gomez-Broughton C, Kane RC, Kirshner S, Mehrotra N, Ricks TK, Schmiel D, Song P, Zhao P, Zhou Q, Farrell AT, Pazdur R.

Clin Cancer Res. 2015 Sep 15;21(18):4035-9. doi: 10.1158/1078-0432.CCR-15-0612.

26.

Acute Myeloid Leukemia Response Measures Other Than Complete Remission.

Przepiorka D, Deisseroth A, Farrell AT.

J Clin Oncol. 2015 Nov 1;33(31):3675-6. doi: 10.1200/JCO.2015.62.0864. Epub 2015 Aug 17. No abstract available.

PMID:
26282653
27.

FDA Approval: Ibrutinib for Patients with Previously Treated Mantle Cell Lymphoma and Previously Treated Chronic Lymphocytic Leukemia.

de Claro RA, McGinn KM, Verdun N, Lee SL, Chiu HJ, Saber H, Brower ME, Chang CJ, Pfuma E, Habtemariam B, Bullock J, Wang Y, Nie L, Chen XH, Lu DR, Al-Hakim A, Kane RC, Kaminskas E, Justice R, Farrell AT, Pazdur R.

Clin Cancer Res. 2015 Aug 15;21(16):3586-90. doi: 10.1158/1078-0432.CCR-14-2225.

28.

Regulatory perspective on minimal residual disease flow cytometry testing in multiple myeloma.

Gormley NJ, Turley DM, Dickey JS, Farrell AT, Reaman GH, Stafford E, Carrington L, Marti GE.

Cytometry B Clin Cytom. 2016 Jan;90(1):73-80. doi: 10.1002/cyto.b.21268. Epub 2015 Jul 25.

29.

FDA Approval: Belinostat for the Treatment of Patients with Relapsed or Refractory Peripheral T-cell Lymphoma.

Lee HZ, Kwitkowski VE, Del Valle PL, Ricci MS, Saber H, Habtemariam BA, Bullock J, Bloomquist E, Li Shen Y, Chen XH, Brown J, Mehrotra N, Dorff S, Charlab R, Kane RC, Kaminskas E, Justice R, Farrell AT, Pazdur R.

Clin Cancer Res. 2015 Jun 15;21(12):2666-70. doi: 10.1158/1078-0432.CCR-14-3119. Epub 2015 Mar 23.

30.

FDA approval: idelalisib monotherapy for the treatment of patients with follicular lymphoma and small lymphocytic lymphoma.

Miller BW, Przepiorka D, de Claro RA, Lee K, Nie L, Simpson N, Gudi R, Saber H, Shord S, Bullock J, Marathe D, Mehrotra N, Hsieh LS, Ghosh D, Brown J, Kane RC, Justice R, Kaminskas E, Farrell AT, Pazdur R.

Clin Cancer Res. 2015 Apr 1;21(7):1525-9. doi: 10.1158/1078-0432.CCR-14-2522. Epub 2015 Feb 2.

31.

U.S. Food and drug administration approval: obinutuzumab in combination with chlorambucil for the treatment of previously untreated chronic lymphocytic leukemia.

Lee HZ, Miller BW, Kwitkowski VE, Ricci S, DelValle P, Saber H, Grillo J, Bullock J, Florian J, Mehrotra N, Ko CW, Nie L, Shapiro M, Tolnay M, Kane RC, Kaminskas E, Justice R, Farrell AT, Pazdur R.

Clin Cancer Res. 2014 Aug 1;20(15):3902-7. doi: 10.1158/1078-0432.CCR-14-0516. Epub 2014 May 13.

32.

U.S. Food and Drug Administration approval summary: omacetaxine mepesuccinate as treatment for chronic myeloid leukemia.

Alvandi F, Kwitkowski VE, Ko CW, Rothmann MD, Ricci S, Saber H, Ghosh D, Brown J, Pfeiler E, Chikhale E, Grillo J, Bullock J, Kane R, Kaminskas E, Farrell AT, Pazdur R.

Oncologist. 2014 Jan;19(1):94-9. doi: 10.1634/theoncologist.2013-0077. Epub 2013 Dec 5.

33.

U.s. Food and Drug Administration approval: carfilzomib for the treatment of multiple myeloma.

Herndon TM, Deisseroth A, Kaminskas E, Kane RC, Koti KM, Rothmann MD, Habtemariam B, Bullock J, Bray JD, Hawes J, Palmby TR, Jee J, Adams W, Mahayni H, Brown J, Dorantes A, Sridhara R, Farrell AT, Pazdur R.

Clin Cancer Res. 2013 Sep 1;19(17):4559-63. doi: 10.1158/1078-0432.CCR-13-0755. Epub 2013 Jun 17.

34.

Gemtuzumab ozogamicin.

Przepiorka D, Deisseroth A, Kane R, Kaminskas E, Farrell AT, Pazdur R.

J Clin Oncol. 2013 May 1;31(13):1699-700. doi: 10.1200/JCO.2012.48.1887. Epub 2013 Mar 25. No abstract available.

PMID:
23530094
35.

The role of the U.S. Food and Drug Administration review process: clinical trial endpoints in oncology.

McKee AE, Farrell AT, Pazdur R, Woodcock J.

Oncologist. 2010;15 Suppl 1:13-8. doi: 10.1634/theoncologist.2010-S1-13.

36.

FDA approval summary: temsirolimus as treatment for advanced renal cell carcinoma.

Kwitkowski VE, Prowell TM, Ibrahim A, Farrell AT, Justice R, Mitchell SS, Sridhara R, Pazdur R.

Oncologist. 2010;15(4):428-35. doi: 10.1634/theoncologist.2009-0178. Epub 2010 Mar 23.

37.

Sorafenib for the treatment of unresectable hepatocellular carcinoma.

Kane RC, Farrell AT, Madabushi R, Booth B, Chattopadhyay S, Sridhara R, Justice R, Pazdur R.

Oncologist. 2009 Jan;14(1):95-100. doi: 10.1634/theoncologist.2008-0185. Epub 2009 Jan 14. Review.

38.

Expediting the availability of drugs for US patients with cancer.

Farrell AT, Pazdur R, von Eschenbach AC.

Nat Clin Pract Urol. 2008 Dec;5(12):654-6. doi: 10.1038/ncpuro1255. Review. No abstract available.

PMID:
19050708
39.

Ethical, scientific, and regulatory perspectives regarding the use of placebos in cancer clinical trials.

Daugherty CK, Ratain MJ, Emanuel EJ, Farrell AT, Schilsky RL.

J Clin Oncol. 2008 Mar 10;26(8):1371-8. doi: 10.1200/JCO.2007.13.5335. Epub 2008 Jan 28. Review.

PMID:
18227527
40.

Liposomal doxorubicin in combination with bortezomib for relapsed or refractory multiple myeloma.

Ning YM, He K, Dagher R, Sridhara R, Farrell AT, Justice R, Pazdur R.

Oncology (Williston Park). 2007 Nov;21(12):1503-8; discussion 1511, 1513, 1516 passim.

41.

A strategic framework for novel drug development in multiple myeloma.

Anderson KC, Hannah AL, Pazdur R, Farrell AT.

Br J Haematol. 2007 Jul;138(2):153-9. Review. No abstract available.

PMID:
17593022
42.

FDG-PET lymphoma demonstration project invitational workshop.

Kelloff GJ, Sullivan DM, Wilson W, Cheson B, Juweid M, Mills GQ, Zelenetz AD, Horning SJ, Weber W, Sargent DJ, Dodd L, Korn E, Armitage J, Schilsky R, Christian M, O'connor OA, Wang SJ, Farrell AT, Pazdur R, Graham M, Wahl RL, Larson SM, Kostakoglu L, Daube-Witherspoon M, Gastonis C, Siegel BA, Shankar LK, Lee DB, Higley HR, Sigman CC, Carucci D, Timko D, deGennaro LJ, Sigal E, Barker A, Woodcock J.

Acad Radiol. 2007 Mar;14(3):330-9.

PMID:
17307666
43.

Sorafenib for the treatment of advanced renal cell carcinoma.

Kane RC, Farrell AT, Saber H, Tang S, Williams G, Jee JM, Liang C, Booth B, Chidambaram N, Morse D, Sridhara R, Garvey P, Justice R, Pazdur R.

Clin Cancer Res. 2006 Dec 15;12(24):7271-8. Review.

44.
45.

The advisory process for anticancer drug regulation: a global perspective.

Farrell AT, Papadouli I, Hori A, Harczy M, Harrison B, Asakura W, Marty M, Dagher R, Pazdur R.

Ann Oncol. 2006 Jun;17(6):889-96. Epub 2005 Dec 15. Review.

PMID:
16357020
46.

Development of effective new treatments for multiple myeloma.

Anderson KC, Pazdur R, Farrell AT.

J Clin Oncol. 2005 Oct 1;23(28):7207-11. Epub 2005 Sep 6. No abstract available.

PMID:
16145064
47.

FDA drug approval summary: azacitidine (5-azacytidine, Vidaza) for injectable suspension.

Kaminskas E, Farrell AT, Wang YC, Sridhara R, Pazdur R.

Oncologist. 2005 Mar;10(3):176-82. Review.

48.

Approval summary for bortezomib for injection in the treatment of multiple myeloma.

Bross PF, Kane R, Farrell AT, Abraham S, Benson K, Brower ME, Bradley S, Gobburu JV, Goheer A, Lee SL, Leighton J, Liang CY, Lostritto RT, McGuinn WD, Morse DE, Rahman A, Rosario LA, Verbois SL, Williams G, Wang YC, Pazdur R.

Clin Cancer Res. 2004 Jun 15;10(12 Pt 1):3954-64. No abstract available.

49.

Velcade: U.S. FDA approval for the treatment of multiple myeloma progressing on prior therapy.

Kane RC, Bross PF, Farrell AT, Pazdur R.

Oncologist. 2003;8(6):508-13. Review.

50.

Oncology drug review process.

Farrell AT, Pazdur R.

J Natl Compr Canc Netw. 2003 Jan;1(1):109-13. Review.

PMID:
19764154

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