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Items: 1 to 50 of 117

1.

Prevalence of Moisture-Associated Skin Damage in an Acute Care Setting: Outcomes From a Quality Improvement Project.

Werth SL, Justice R.

J Wound Ostomy Continence Nurs. 2019 Jan/Feb;46(1):51-54. doi: 10.1097/WON.0000000000000499.

PMID:
30608341
2.

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.

3.

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.

4.

FDA approval: ceritinib for the treatment of metastatic anaplastic lymphoma kinase-positive non-small cell lung cancer.

Khozin S, Blumenthal GM, Zhang L, Tang S, Brower M, Fox E, Helms W, Leong R, Song P, Pan Y, Liu Q, Zhao P, Zhao H, Lu D, Tang Z, Al Hakim A, Boyd K, Keegan P, Justice R, Pazdur R.

Clin Cancer Res. 2015 Jun 1;21(11):2436-9. doi: 10.1158/1078-0432.CCR-14-3157. Epub 2015 Mar 9.

5.

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.

6.

FDA approval: siltuximab for the treatment of patients with multicentric Castleman disease.

Deisseroth A, Ko CW, Nie L, Zirkelbach JF, Zhao L, Bullock J, Mehrotra N, Del Valle P, Saber H, Sheth C, Gehrke B, Justice R, Farrell A, Pazdur R.

Clin Cancer Res. 2015 Mar 1;21(5):950-4. doi: 10.1158/1078-0432.CCR-14-1678. Epub 2015 Jan 19. Review.

7.

Assessment of benefits and risks in development of targeted therapies for cancer--The view of regulatory authorities.

Pignatti F, Jonsson B, Blumenthal G, Justice R.

Mol Oncol. 2015 May;9(5):1034-41. doi: 10.1016/j.molonc.2014.10.003. Epub 2014 Oct 16. Review.

8.

First FDA approval of neoadjuvant therapy for breast cancer: pertuzumab for the treatment of patients with HER2-positive breast cancer.

Amiri-Kordestani L, Wedam S, Zhang L, Tang S, Tilley A, Ibrahim A, Justice R, Pazdur R, Cortazar P.

Clin Cancer Res. 2014 Nov 1;20(21):5359-64. doi: 10.1158/1078-0432.CCR-14-1268. Epub 2014 Sep 9. Review.

9.

FDA approval summary: crizotinib for the treatment of metastatic non-small cell lung cancer with anaplastic lymphoma kinase rearrangements.

Kazandjian D, Blumenthal GM, Chen HY, He K, Patel M, Justice R, Keegan P, Pazdur R.

Oncologist. 2014 Oct;19(10):e5-11. doi: 10.1634/theoncologist.2014-0241. Epub 2014 Aug 28.

10.

FDA approval summary: vemurafenib for treatment of unresectable or metastatic melanoma with the BRAFV600E mutation.

Kim G, McKee AE, Ning YM, Hazarika M, Theoret M, Johnson JR, Xu QC, Tang S, Sridhara R, Jiang X, He K, Roscoe D, McGuinn WD, Helms WS, Russell AM, Miksinski SP, Zirkelbach JF, Earp J, Liu Q, Ibrahim A, Justice R, Pazdur R.

Clin Cancer Res. 2014 Oct 1;20(19):4994-5000. doi: 10.1158/1078-0432.CCR-14-0776. Epub 2014 Aug 5. Review.

11.

FDA approval: ado-trastuzumab emtansine for the treatment of patients with HER2-positive metastatic breast cancer.

Amiri-Kordestani L, Blumenthal GM, Xu QC, Zhang L, Tang SW, Ha L, Weinberg WC, Chi B, Candau-Chacon R, Hughes P, Russell AM, Miksinski SP, Chen XH, McGuinn WD, Palmby T, Schrieber SJ, Liu Q, Wang J, Song P, Mehrotra N, Skarupa L, Clouse K, Al-Hakim A, Sridhara R, Ibrahim A, Justice R, Pazdur R, Cortazar P.

Clin Cancer Res. 2014 Sep 1;20(17):4436-41. doi: 10.1158/1078-0432.CCR-14-0012. Epub 2014 May 30.

12.

U.S. Food and Drug Administration approval summary: Erlotinib for the first-line treatment of metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or exon 21 (L858R) substitution mutations.

Khozin S, Blumenthal GM, Jiang X, He K, Boyd K, Murgo A, Justice R, Keegan P, Pazdur R.

Oncologist. 2014 Jul;19(7):774-9. doi: 10.1634/theoncologist.2014-0089. Epub 2014 May 27.

13.

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.

14.

Reply to Letter to the Editor: Local Evaluation and Blinded Central Review Comparison a Victim of Meta-analysis Shortcomings.

Zhang JJ, Chen H, He K, Tang S, Justice R, Keegan P, Pazdur R, Sridhara R.

Ther Innov Regul Sci. 2014 Mar;48(2):NP1-NP2. doi: 10.1177/2168479014520698. No abstract available.

PMID:
30227504
15.

U.S. Food and Drug Administration approval: crizotinib for treatment of advanced or metastatic non-small cell lung cancer that is anaplastic lymphoma kinase positive.

Malik SM, Maher VE, Bijwaard KE, Becker RL, Zhang L, Tang SW, Song P, Liu Q, Marathe A, Gehrke B, Helms W, Hanner D, Justice R, Pazdur R.

Clin Cancer Res. 2014 Apr 15;20(8):2029-34. doi: 10.1158/1078-0432.CCR-13-3077. Epub 2014 Feb 26.

16.

Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis.

Cortazar P, Zhang L, Untch M, Mehta K, Costantino JP, Wolmark N, Bonnefoi H, Cameron D, Gianni L, Valagussa P, Swain SM, Prowell T, Loibl S, Wickerham DL, Bogaerts J, Baselga J, Perou C, Blumenthal G, Blohmer J, Mamounas EP, Bergh J, Semiglazov V, Justice R, Eidtmann H, Paik S, Piccart M, Sridhara R, Fasching PA, Slaets L, Tang S, Gerber B, Geyer CE Jr, Pazdur R, Ditsch N, Rastogi P, Eiermann W, von Minckwitz G.

Lancet. 2014 Jul 12;384(9938):164-72. doi: 10.1016/S0140-6736(13)62422-8. Epub 2014 Feb 14. Review. Erratum in: Lancet. 2019 Mar 9;393(10175):986.

PMID:
24529560
17.

Exposure-response relationship of T-DM1: insight into dose optimization for patients with HER2-positive metastatic breast cancer.

Wang J, Song P, Schrieber S, Liu Q, Xu Q, Blumenthal G, Amiri Kordestani L, Cortazar P, Ibrahim A, Justice R, Wang Y, Tang S, Booth B, Mehrotra N, Rahman A.

Clin Pharmacol Ther. 2014 May;95(5):558-64. doi: 10.1038/clpt.2014.24. Epub 2014 Jan 31.

PMID:
24488143
18.

Pain palliation measurement in cancer clinical trials: the US Food and Drug Administration perspective.

Basch E, Trentacosti AM, Burke LB, Kwitkowski V, Kane RC, Autio KA, Papadopoulos E, Stansbury JP, Kluetz PG, Smith H, Justice R, Pazdur R.

Cancer. 2014 Mar 1;120(5):761-7. doi: 10.1002/cncr.28470. Epub 2013 Dec 5.

19.

Radium Ra 223 dichloride injection: U.S. Food and Drug Administration drug approval summary.

Kluetz PG, Pierce W, Maher VE, Zhang H, Tang S, Song P, Liu Q, Haber MT, Leutzinger EE, Al-Hakim A, Chen W, Palmby T, Alebachew E, Sridhara R, Ibrahim A, Justice R, Pazdur R.

Clin Cancer Res. 2014 Jan 1;20(1):9-14. doi: 10.1158/1078-0432.CCR-13-2665. Epub 2013 Nov 4.

20.

Abiraterone acetate in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer: U.S. Food and Drug Administration drug approval summary.

Kluetz PG, Ning YM, Maher VE, Zhang L, Tang S, Ghosh D, Aziz R, Palmby T, Pfuma E, Zirkelbach JF, Mehrotra N, Tilley A, Sridhara R, Ibrahim A, Justice R, Pazdur R.

Clin Cancer Res. 2013 Dec 15;19(24):6650-6. doi: 10.1158/1078-0432.CCR-13-2134. Epub 2013 Oct 22.

21.

Enzalutamide for treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel: U.S. Food and Drug Administration drug approval summary.

Ning YM, Pierce W, Maher VE, Karuri S, Tang SH, Chiu HJ, Palmby T, Zirkelbach JF, Marathe D, Mehrotra N, Liu Q, Ghosh D, Cottrell CL, Leighton J, Sridhara R, Ibrahim A, Justice R, Pazdur R.

Clin Cancer Res. 2013 Nov 15;19(22):6067-73. doi: 10.1158/1078-0432.CCR-13-1763. Epub 2013 Oct 18.

22.

First FDA approval of dual anti-HER2 regimen: pertuzumab in combination with trastuzumab and docetaxel for HER2-positive metastatic breast cancer.

Blumenthal GM, Scher NS, Cortazar P, Chattopadhyay S, Tang S, Song P, Liu Q, Ringgold K, Pilaro AM, Tilley A, King KE, Graham L, Rellahan BL, Weinberg WC, Chi B, Thomas C, Hughes P, Ibrahim A, Justice R, Pazdur R.

Clin Cancer Res. 2013 Sep 15;19(18):4911-6. doi: 10.1158/1078-0432.CCR-13-1212. Epub 2013 Jun 25.

23.

Evaluation of Blinded Independent Central Review of Tumor Progression in Oncology Clinical Trials: A Meta-analysis.

Zhang JJ, Chen H, He K, Tang S, Justice R, Keegan P, Pazdur R, Sridhara R.

Ther Innov Regul Sci. 2013 Mar;47(2):167-174. doi: 10.1177/0092861512459733.

PMID:
30227523
24.

FDA approval summary: sunitinib for the treatment of progressive well-differentiated locally advanced or metastatic pancreatic neuroendocrine tumors.

Blumenthal GM, Cortazar P, Zhang JJ, Tang S, Sridhara R, Murgo A, Justice R, Pazdur R.

Oncologist. 2012;17(8):1108-13. doi: 10.1634/theoncologist.2012-0044. Epub 2012 Jul 26.

25.

Vandetanib for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease: U.S. Food and Drug Administration drug approval summary.

Thornton K, Kim G, Maher VE, Chattopadhyay S, Tang S, Moon YJ, Song P, Marathe A, Balakrishnan S, Zhu H, Garnett C, Liu Q, Booth B, Gehrke B, Dorsam R, Verbois L, Ghosh D, Wilson W, Duan J, Sarker H, Miksinski SP, Skarupa L, Ibrahim A, Justice R, Murgo A, Pazdur R.

Clin Cancer Res. 2012 Jul 15;18(14):3722-30. doi: 10.1158/1078-0432.CCR-12-0411. Epub 2012 Jun 4.

26.

Approval summary: imatinib mesylate for one or three years in the adjuvant treatment of gastrointestinal stromal tumors.

Cohen MH, Johnson JR, Justice R, Pazdur R.

Oncologist. 2012;17(7):992-7. doi: 10.1634/theoncologist.2012-0109. Epub 2012 May 29.

27.

US Food and Drug Administration approval overview in metastatic breast cancer.

Cortazar P, Justice R, Johnson J, Sridhara R, Keegan P, Pazdur R.

J Clin Oncol. 2012 May 10;30(14):1705-11. doi: 10.1200/JCO.2011.39.2613. Epub 2012 Mar 19. Review. No abstract available.

28.

Approval summary: letrozole (Femara® tablets) for adjuvant and extended adjuvant postmenopausal breast cancer treatment: conversion of accelerated to full approval.

Cohen MH, Johnson JR, Justice R, Pazdur R.

Oncologist. 2011;16(12):1762-70. doi: 10.1634/theoncologist.2011-0287. Epub 2011 Nov 16. Review.

29.

The risks and benefits of 5α-reductase inhibitors for prostate-cancer prevention.

Theoret MR, Ning YM, Zhang JJ, Justice R, Keegan P, Pazdur R.

N Engl J Med. 2011 Jul 14;365(2):97-9. doi: 10.1056/NEJMp1106783. Epub 2011 Jun 15. No abstract available.

PMID:
21675880
30.

Accelerated approval of oncology products: the food and drug administration experience.

Johnson JR, Ning YM, Farrell A, Justice R, Keegan P, Pazdur R.

J Natl Cancer Inst. 2011 Apr 20;103(8):636-44. doi: 10.1093/jnci/djr062. Epub 2011 Mar 21. Review.

PMID:
21422403
31.

Approval summary: pemetrexed maintenance therapy of advanced/metastatic nonsquamous, non-small cell lung cancer (NSCLC).

Cohen MH, Cortazar P, Justice R, Pazdur R.

Oncologist. 2010;15(12):1352-8. doi: 10.1634/theoncologist.2010-0224. Epub 2010 Dec 10.

32.

Approval summary: erlotinib maintenance therapy of advanced/metastatic non-small cell lung cancer (NSCLC).

Cohen MH, Johnson JR, Chattopadhyay S, Tang S, Justice R, Sridhara R, Pazdur R.

Oncologist. 2010;15(12):1344-51. doi: 10.1634/theoncologist.2010-0257. Epub 2010 Dec 10.

33.

Folotyn (pralatrexate injection) for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma: U.S. Food and Drug Administration drug approval summary.

Malik SM, Liu K, Qiang X, Sridhara R, Tang S, McGuinn WD Jr, Verbois SL, Marathe A, Williams GM, Bullock J, Tornoe C, Lin SC, Ocheltree T, Vialpando M, Kacuba A, Justice R, Pazdur R.

Clin Cancer Res. 2010 Oct 15;16(20):4921-7. doi: 10.1158/1078-0432.CCR-10-1214. Epub 2010 Aug 25. Review.

34.

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.

Brave M, Farrell A, Ching Lin S, Ocheltree T, Pope Miksinski S, Lee SL, Saber H, Fourie J, Tornoe C, Booth B, Yuan W, He K, Justice R, Pazdur R.

Oncology. 2010;78(3-4):282-8. doi: 10.1159/000315736. Epub 2010 Jun 8.

PMID:
20530974
35.

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.

36.

The Anopheles gambiae odorant binding protein 1 (AgamOBP1) mediates indole recognition in the antennae of female mosquitoes.

Biessmann H, Andronopoulou E, Biessmann MR, Douris V, Dimitratos SD, Eliopoulos E, Guerin PM, Iatrou K, Justice RW, Kröber T, Marinotti O, Tsitoura P, Woods DF, Walter MF.

PLoS One. 2010 Mar 1;5(3):e9471. doi: 10.1371/journal.pone.0009471.

37.

Approval summary: imatinib mesylate in the adjuvant treatment of malignant gastrointestinal stromal tumors.

Cohen MH, Cortazar P, Justice R, Pazdur R.

Oncologist. 2010;15(3):300-7. doi: 10.1634/theoncologist.2009-0120. Epub 2010 Mar 3.

38.

Accelerated approval and oncology drug development timelines.

Lanthier ML, Sridhara R, Johnson JR, Farrell A, Keegan P, Justice R, Pazdur R.

J Clin Oncol. 2010 May 10;28(14):e226-7; author reply e228. doi: 10.1200/JCO.2009.26.2121. Epub 2010 Mar 1. No abstract available.

PMID:
20194846
39.

Review of oncology and hematology drug product approvals at the US Food and Drug Administration between July 2005 and December 2007.

Sridhara R, Johnson JR, Justice R, Keegan P, Chakravarty A, Pazdur R.

J Natl Cancer Inst. 2010 Feb 24;102(4):230-43. doi: 10.1093/jnci/djp515. Epub 2010 Jan 29. Review. Erratum in: J Natl Cancer Inst. 2010 Apr 21;102(8):578-9.

PMID:
20118413
40.

Toxicity of laromustine plus high-dose cytarabine in patients with relapsed acute myeloid leukemia.

Deisseroth A, Farrell A, Justice R, Kane R, Sridhara R, Chen H, He K, Pazdur R.

Blood. 2010 Jan 14;115(2):430. doi: 10.1182/blood-2009-09-244236. No abstract available.

PMID:
20075171
41.

Approval summary: pemetrexed in the initial treatment of advanced/metastatic non-small cell lung cancer.

Cohen MH, Justice R, Pazdur R.

Oncologist. 2009 Sep;14(9):930-5. doi: 10.1634/theoncologist.2009-0092. Epub 2009 Sep 8.

42.

Assessing proarrhythmic potential of drugs when optimal studies are infeasible.

Rock EP, Finkle J, Fingert HJ, Booth BP, Garnett CE, Grant S, Justice RL, Kovacs RJ, Kowey PR, Rodriguez I, Sanhai WR, Strnadova C, Targum SL, Tsong Y, Uhl K, Stockbridge N.

Am Heart J. 2009 May;157(5):827-36, 836.e1. doi: 10.1016/j.ahj.2009.02.020. Review.

PMID:
19376308
43.

Approval summary: imatinib mesylate in the treatment of metastatic and/or unresectable malignant gastrointestinal stromal tumors.

Cohen MH, Farrell A, Justice R, Pazdur R.

Oncologist. 2009 Feb;14(2):174-80. doi: 10.1634/theoncologist.2008-0255. Epub 2009 Feb 4.

44.

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.

45.

Lenalidomide in combination with dexamethasone for the treatment of multiple myeloma after one prior therapy.

Hazarika M, Rock E, Williams G, Dagher R, Sridhara R, Booth B, Farrell A, Justice R, Pazdur R.

Oncologist. 2008 Oct;13(10):1120-7. doi: 10.1634/theoncologist.2008-0077. Epub 2008 Oct 15.

46.

FDA drug approval summary: lapatinib in combination with capecitabine for previously treated metastatic breast cancer that overexpresses HER-2.

Ryan Q, Ibrahim A, Cohen MH, Johnson J, Ko CW, Sridhara R, Justice R, Pazdur R.

Oncologist. 2008 Oct;13(10):1114-9. doi: 10.1634/theoncologist.2008-0816. Epub 2008 Oct 10.

47.

Tasigna for chronic and accelerated phase Philadelphia chromosome--positive chronic myelogenous leukemia resistant to or intolerant of imatinib.

Hazarika M, Jiang X, Liu Q, Lee SL, Ramchandani R, Garnett C, Orr MS, Sridhara R, Booth B, Leighton JK, Timmer W, Harapanhalli R, Dagher R, Justice R, Pazdur R.

Clin Cancer Res. 2008 Sep 1;14(17):5325-31. doi: 10.1158/1078-0432.CCR-08-0308.

48.

Ixabepilone in combination with capecitabine and as monotherapy for treatment of advanced breast cancer refractory to previous chemotherapies.

Lechleider RJ, Kaminskas E, Jiang X, Aziz R, Bullock J, Kasliwal R, Harapanhalli R, Pope S, Sridhara R, Leighton J, Booth B, Dagher R, Justice R, Pazdur R.

Clin Cancer Res. 2008 Jul 15;14(14):4378-84. doi: 10.1158/1078-0432.CCR-08-0015.

49.

FDA drug approval summary: nelarabine (Arranon) for the treatment of T-cell lymphoblastic leukemia/lymphoma.

Cohen MH, Johnson JR, Justice R, Pazdur R.

Oncologist. 2008 Jun;13(6):709-14. doi: 10.1634/theoncologist.2006-0017.

50.

Dexrazoxane (Totect): FDA review and approval for the treatment of accidental extravasation following intravenous anthracycline chemotherapy.

Kane RC, McGuinn WD Jr, Dagher R, Justice R, Pazdur R.

Oncologist. 2008 Apr;13(4):445-50. doi: 10.1634/theoncologist.2007-0247.

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