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Items: 1 to 50 of 136

1.

Evaluation of Serious Postmarket Safety Signals Within 2 Years of FDA Approval for New Cancer Drugs.

Kim J, Nair A, Keegan P, Beaver JA, Kluetz PG, Pazdur R, Chuk M, Blumenthal GM.

Oncologist. 2019 Dec 17. pii: theoncologist.2019-0653. doi: 10.1634/theoncologist.2019-0653. [Epub ahead of print]

2.

Post-procedure protocol to facilitate next-day discharge: Results of the multidisciplinary, multimodality but minimalist TAVR study.

Lauck SB, Sathananthan J, Park J, Achtem L, Smith A, Keegan P, Hawkey M, Brandwein R, Webb JG, Wood DA; 3M TAVR Investigators, and Nursing and Allied Health Professional Site Leaders.

Catheter Cardiovasc Interv. 2019 Nov 29. doi: 10.1002/ccd.28617. [Epub ahead of print]

PMID:
31785087
3.

Prognostic Value of the Lung Immune Prognostic Index for Patients Treated for Metastatic Non-Small Cell Lung Cancer.

Kazandjian D, Gong Y, Keegan P, Pazdur R, Blumenthal GM.

JAMA Oncol. 2019 Jul 25. doi: 10.1001/jamaoncol.2019.1747. [Epub ahead of print]

PMID:
31343662
4.

Balloon expandable transcatheter aortic valve replacement outcomes by procedure location: Catheterization laboratory versus operating room.

Nguyen TC, Keegan P, Nguyen S, Loyalka P, Kaneko T, Shah PB, Grubb KJ, Babaliaros VC.

Cardiovasc Revasc Med. 2019 Apr 30. pii: S1553-8389(19)30233-7. doi: 10.1016/j.carrev.2019.04.007. [Epub ahead of print]

PMID:
31178348
5.

Imaging for Predicting, Detecting, and Managing Complications After Transcatheter Aortic Valve Replacement.

Corrigan FE 3rd, Gleason PT, Condado JF, Lisko JC, Chen JH, Kamioka N, Keegan P, Howell S, Clements SD Jr, Babaliaros VC, Lerakis S.

JACC Cardiovasc Imaging. 2019 May;12(5):904-920. doi: 10.1016/j.jcmg.2018.07.036. Review.

PMID:
31072518
6.

A thermoplastic microfluidic microphysiological system to recapitulate hepatic function and multicellular interactions.

Bale SS, Manoppo A, Thompson R, Markoski A, Coppeta J, Cain B, Haroutunian N, Newlin V, Spencer A, Azizgolshani H, Lu M, Gosset J, Keegan P, Charest JL.

Biotechnol Bioeng. 2019 Dec;116(12):3409-3420. doi: 10.1002/bit.26986. Epub 2019 Oct 15.

PMID:
30963546
7.

A high-throughput microfluidic microphysiological system (PREDICT-96) to recapitulate hepatocyte function in dynamic, re-circulating flow conditions.

Tan K, Keegan P, Rogers M, Lu M, Gosset JR, Charest J, Bale SS.

Lab Chip. 2019 Apr 23;19(9):1556-1566. doi: 10.1039/c8lc01262h.

PMID:
30855604
8.

FDA Approval Summary: Pembrolizumab for the Treatment of Microsatellite Instability-High Solid Tumors.

Marcus L, Lemery SJ, Keegan P, Pazdur R.

Clin Cancer Res. 2019 Jul 1;25(13):3753-3758. doi: 10.1158/1078-0432.CCR-18-4070. Epub 2019 Feb 20.

PMID:
30787022
9.

Model-informed drug development approach supporting approval of the 4-week (Q4W) dosing schedule for nivolumab (Opdivo) across multiple indications: a regulatory perspective.

Bi Y, Liu J, Furmanski B, Zhao H, Yu J, Osgood C, Ward A, Keegan P, Booth BP, Rahman A, Wang Y.

Ann Oncol. 2019 Apr 1;30(4):644-651. doi: 10.1093/annonc/mdz037.

PMID:
30715147
10.

FDA analyses of survival in older adults with metastatic non-small cell lung cancer in controlled trials of PD-1/PD-L1 blocking antibodies.

Marur S, Singh H, Mishra-Kalyani P, Larkins E, Keegan P, Sridhara R, Blumenthal GM, Pazdur R.

Semin Oncol. 2018 Aug;45(4):220-225. doi: 10.1053/j.seminoncol.2018.08.007. Epub 2018 Oct 31. Review.

PMID:
30391014
11.

Current Status and Future Perspectives on Neoadjuvant Therapy in Lung Cancer.

Blumenthal GM, Bunn PA Jr, Chaft JE, McCoach CE, Perez EA, Scagliotti GV, Carbone DP, Aerts HJWL, Aisner DL, Bergh J, Berry DA, Jarkowski A, Botwood N, Cross DAE, Diehn M, Drezner NL, Doebele RC, Blakely CM, Eberhardt WEE, Felip E, Gianni L, Keller SP, Leavey PJ, Malik S, Pignatti F, Prowell TM, Redman MW, Rizvi NA, Rosell R, Rusch V, de Ruysscher D, Schwartz LH, Sridhara R, Stahel RA, Swisher S, Taube JM, Travis WD, Keegan P, Wiens JR, Wistuba II, Wynes MW, Hirsch FR, Kris MG.

J Thorac Oncol. 2018 Dec;13(12):1818-1831. doi: 10.1016/j.jtho.2018.09.017. Epub 2018 Sep 27. Review.

12.

Pulmonary Venous Waveforms Predict Rehospitalization and Mortality After Percutaneous Mitral Valve Repair.

Corrigan FE 3rd, Chen JH, Maini A, Lisko JC, Alvarez L, Kamioka N, Reginauld S, Gleason PT, Condado JF, Wei JW, Binongo JN, Keegan P, Howell S, Thourani VH, Block PC, Clements SD, Babaliaros VC, Lerakis S.

JACC Cardiovasc Imaging. 2019 Oct;12(10):1905-1913. doi: 10.1016/j.jcmg.2018.07.014. Epub 2018 Sep 12.

PMID:
30219407
13.

FDA Approval Summary: Pembrolizumab for Recurrent Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing PD-L1.

Fashoyin-Aje L, Donoghue M, Chen H, He K, Veeraraghavan J, Goldberg KB, Keegan P, McKee AE, Pazdur R.

Oncologist. 2019 Jan;24(1):103-109. doi: 10.1634/theoncologist.2018-0221. Epub 2018 Aug 17.

14.

Overview of Oncology and Hematology Drug Approvals at US Food and Drug Administration Between 2008 and 2016.

Zhou J, Vallejo J, Kluetz P, Pazdur R, Kim T, Keegan P, Farrell A, Beaver JA, Sridhara R.

J Natl Cancer Inst. 2019 May 1;111(5):449-458. doi: 10.1093/jnci/djy130.

PMID:
30085269
15.

FDA's Approval of the First Biosimilar to Bevacizumab.

Casak SJ, Lemery SJ, Chung J, Fuchs C, Schrieber SJ, Chow ECY, Yuan W, Rodriguez L, Gwise T, Rowzee A, Lim S, Keegan P, McKee AE, Pazdur R.

Clin Cancer Res. 2018 Sep 15;24(18):4365-4370. doi: 10.1158/1078-0432.CCR-18-0566. Epub 2018 May 9.

16.

Anti-PD-1 antibody treatment for melanoma - Authors' reply.

Beaver JA, Keegan P, Lemery S, Pazdur R, Theoret MR.

Lancet Oncol. 2018 May;19(5):e220. doi: 10.1016/S1470-2045(18)30251-1. No abstract available.

PMID:
29726379
17.

Exploratory analysis of the association of depth of response and survival in patients with metastatic non-small-cell lung cancer treated with a targeted therapy or immunotherapy.

McCoach CE, Blumenthal GM, Zhang L, Myers A, Tang S, Sridhara R, Keegan P, Pazdur R, Doebele RC, Kazandjian D.

Ann Oncol. 2019 Mar 1;30(3):492. doi: 10.1093/annonc/mdy045. No abstract available.

18.

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
19.

FDA Approval Summary: Dabrafenib and Trametinib for the Treatment of Metastatic Non-Small Cell Lung Cancers Harboring BRAF V600E Mutations.

Odogwu L, Mathieu L, Blumenthal G, Larkins E, Goldberg KB, Griffin N, Bijwaard K, Lee EY, Philip R, Jiang X, Rodriguez L, McKee AE, Keegan P, Pazdur R.

Oncologist. 2018 Jun;23(6):740-745. doi: 10.1634/theoncologist.2017-0642. Epub 2018 Feb 7.

20.

Benefit-Risk Summary of Regorafenib for the Treatment of Patients with Advanced Hepatocellular Carcinoma That Has Progressed on Sorafenib.

Pelosof L, Lemery S, Casak S, Jiang X, Rodriguez L, Pierre V, Bi Y, Liu J, Zirkelbach JF, Patel A, Goldberg KB, McKee AE, Keegan P, Pazdur R.

Oncologist. 2018 Apr;23(4):496-500. doi: 10.1634/theoncologist.2017-0422. Epub 2018 Jan 31.

21.

Mean Aortic pressure gradient and global longitudinal strain recovery after transcatheter aortic valve replacement - A retrospective analysis.

Corrigan FE, Zhou X, Lisko JC, Hayek SS, Parastatidis I, Keegan P, Howell S, Thourani V, Babaliaros VC, Lerakis S.

Hellenic J Cardiol. 2018 Sep - Oct;59(5):268-271. doi: 10.1016/j.hjc.2018.01.006. Epub 2018 Jan 31.

22.

Patients with melanoma treated with an anti-PD-1 antibody beyond RECIST progression: a US Food and Drug Administration pooled analysis.

Beaver JA, Hazarika M, Mulkey F, Mushti S, Chen H, He K, Sridhara R, Goldberg KB, Chuk MK, Chi DC, Chang J, Barone A, Balasubramaniam S, Blumenthal GM, Keegan P, Pazdur R, Theoret MR.

Lancet Oncol. 2018 Feb;19(2):229-239. doi: 10.1016/S1470-2045(17)30846-X. Epub 2018 Jan 18. Review.

23.

Predictors and Clinical Outcomes of Next-Day Discharge After Minimalist Transfemoral Transcatheter Aortic Valve Replacement.

Kamioka N, Wells J, Keegan P, Lerakis S, Binongo J, Corrigan F, Condado J, Patel A, Forcillo J, Ogburn L, Dong A, Caughron H, Simone A, Leshnower B, Devireddy C, Mavromatis K, Guyton R, Stewart J, Thourani V, Block PC, Babaliaros V.

JACC Cardiovasc Interv. 2018 Jan 22;11(2):107-115. doi: 10.1016/j.jcin.2017.10.021.

24.

FDA Benefit-Risk Assessment of Osimertinib for the Treatment of Metastatic Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor T790M Mutation.

Odogwu L, Mathieu L, Goldberg KB, Blumenthal GM, Larkins E, Fiero MH, Rodriguez L, Bijwaard K, Lee EY, Philip R, Fan I, Donoghue M, Keegan P, McKee A, Pazdur R.

Oncologist. 2018 Mar;23(3):353-359. doi: 10.1634/theoncologist.2017-0425. Epub 2017 Dec 14.

25.

Exploratory analysis of the association of depth of response and survival in patients with metastatic non-small-cell lung cancer treated with a targeted therapy or immunotherapy.

McCoach CE, Blumenthal GM, Zhang L, Myers A, Tang S, Sridhara R, Keegan P, Pazdur R, Doebele RC, Kazandjian D.

Ann Oncol. 2017 Nov 1;28(11):2707-2714. doi: 10.1093/annonc/mdx414. Erratum in: Ann Oncol. 2019 Mar 1;30(3):492.

26.

First FDA Approval Agnostic of Cancer Site - When a Biomarker Defines the Indication.

Lemery S, Keegan P, Pazdur R.

N Engl J Med. 2017 Oct 12;377(15):1409-1412. doi: 10.1056/NEJMp1709968. No abstract available.

PMID:
29020592
27.

FDA Approval Summary: Sonidegib-Response.

Shord SS, Casey D, Zhao H, Demko S, Keegan P, Pazdur R.

Clin Cancer Res. 2017 Oct 1;23(19):5994. doi: 10.1158/1078-0432.CCR-17-2135. No abstract available.

28.

FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non-Small Cell Lung Cancer: First-Line Therapy and Beyond.

Pai-Scherf L, Blumenthal GM, Li H, Subramaniam S, Mishra-Kalyani PS, He K, Zhao H, Yu J, Paciga M, Goldberg KB, McKee AE, Keegan P, Pazdur R.

Oncologist. 2017 Nov;22(11):1392-1399. doi: 10.1634/theoncologist.2017-0078. Epub 2017 Aug 23.

29.

FDA Approval Summary: Trabectedin for Unresectable or Metastatic Liposarcoma or Leiomyosarcoma Following an Anthracycline-Containing Regimen.

Barone A, Chi DC, Theoret MR, Chen H, He K, Kufrin D, Helms WS, Subramaniam S, Zhao H, Patel A, Goldberg KB, Keegan P, Pazdur R.

Clin Cancer Res. 2017 Dec 15;23(24):7448-7453. doi: 10.1158/1078-0432.CCR-17-0898. Epub 2017 Aug 3.

30.

Urethral injection therapy for urinary incontinence in women.

Kirchin V, Page T, Keegan PE, Atiemo KO, Cody JD, McClinton S, Aluko P.

Cochrane Database Syst Rev. 2017 Jul 25;7:CD003881. doi: 10.1002/14651858.CD003881.pub4. Review.

31.

Te Reo Māori: indigenous language acquisition in the context of New Zealand English.

Reese E, Keegan P, McNaughton S, Kingi TK, Carr PA, Schmidt J, Mohal J, Grant C, Morton S.

J Child Lang. 2018 Mar;45(2):340-367. doi: 10.1017/S0305000917000241. Epub 2017 Jul 6.

PMID:
28679455
32.

Milestone Analyses of Immune Checkpoint Inhibitors, Targeted Therapy, and Conventional Therapy in Metastatic Non-Small Cell Lung Cancer Trials: A Meta-analysis.

Blumenthal GM, Zhang L, Zhang H, Kazandjian D, Khozin S, Tang S, Goldberg K, Sridhara R, Keegan P, Pazdur R.

JAMA Oncol. 2017 Aug 10;3(8):e171029. doi: 10.1001/jamaoncol.2017.1029. Epub 2017 Aug 10.

33.

Time dependent pharmacokinetics of pembrolizumab in patients with solid tumor and its correlation with best overall response.

Li H, Yu J, Liu C, Liu J, Subramaniam S, Zhao H, Blumenthal GM, Turner DC, Li C, Ahamadi M, de Greef R, Chatterjee M, Kondic AG, Stone JA, Booth BP, Keegan P, Rahman A, Wang Y.

J Pharmacokinet Pharmacodyn. 2017 Oct;44(5):403-414. doi: 10.1007/s10928-017-9528-y. Epub 2017 Jun 1.

PMID:
28573468
34.

FDA Approval Summary: Pembrolizumab for the Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma with Disease Progression on or After Platinum-Containing Chemotherapy.

Larkins E, Blumenthal GM, Yuan W, He K, Sridhara R, Subramaniam S, Zhao H, Liu C, Yu J, Goldberg KB, McKee AE, Keegan P, Pazdur R.

Oncologist. 2017 Jul;22(7):873-878. doi: 10.1634/theoncologist.2016-0496. Epub 2017 May 22.

35.

Readmission rates after transcatheter aortic valve replacement in high- and extreme-risk patients with severe aortic stenosis.

Forcillo J, Condado JF, Binongo JN, Lasanajak Y, Caughron H, Babaliaros V, Devireddy C, Leshnower B, Guyton RA, Block PC, Simone A, Keegan P, Khairy P, Thourani VH.

J Thorac Cardiovasc Surg. 2017 Aug;154(2):445-452. doi: 10.1016/j.jtcvs.2017.03.144. Epub 2017 Apr 18.

36.

Characterization of outcomes in patients with metastatic non-small cell lung cancer treated with programmed cell death protein 1 inhibitors past RECIST version 1.1-defined disease progression in clinical trials.

Kazandjian D, Keegan P, Suzman DL, Pazdur R, Blumenthal GM.

Semin Oncol. 2017 Feb;44(1):3-7. doi: 10.1053/j.seminoncol.2017.01.001. Epub 2017 Feb 10. Review.

PMID:
28395760
37.

Paravalvular Regurgitation after Transcatheter Aortic Valve Replacement: Comparing Transthoracic versus Transesophageal Echocardiographic Guidance.

Hayek SS, Corrigan FE 3rd, Condado JF, Lin S, Howell S, MacNamara JP, Zheng S, Keegan P, Thourani V, Babaliaros VC, Lerakis S.

J Am Soc Echocardiogr. 2017 Jun;30(6):533-540. doi: 10.1016/j.echo.2017.02.002. Epub 2017 Apr 6. Erratum in: J Am Soc Echocardiogr. 2017 Oct;30(10):1047.

PMID:
28391002
38.

FDA Approval Summary: Eribulin for Patients with Unresectable or Metastatic Liposarcoma Who Have Received a Prior Anthracycline-Containing Regimen.

Osgood CL, Chuk MK, Theoret MR, Huang L, He K, Her L, Keegan P, Pazdur R.

Clin Cancer Res. 2017 Nov 1;23(21):6384-6389. doi: 10.1158/1078-0432.CCR-16-2422. Epub 2017 Feb 27.

39.

FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma.

Chuk MK, Chang JT, Theoret MR, Sampene E, He K, Weis SL, Helms WS, Jin R, Li H, Yu J, Zhao H, Zhao L, Paciga M, Schmiel D, Rawat R, Keegan P, Pazdur R.

Clin Cancer Res. 2017 Oct 1;23(19):5666-5670. doi: 10.1158/1078-0432.CCR-16-0663. Epub 2017 Feb 24.

40.

FDA Approval Summary: TAS-102.

Marcus L, Lemery SJ, Khasar S, Wearne E, Helms WS, Yuan W, He K, Cao X, Yu J, Zhao H, Wang Y, Stephens O, Englund E, Agarwal R, Keegan P, Pazdur R.

Clin Cancer Res. 2017 Jun 15;23(12):2924-2927. doi: 10.1158/1078-0432.CCR-16-2157. Epub 2017 Feb 17.

41.

End-stage renal disease and severe aortic stenosis: Does valve replacement improve one-year outcomes?

Condado JF, Maini A, Leshnower B, Thourani V, Forcillo J, Devireddy C, Mavromatis K, Sarin EL, Stewart J, Guyton R, Simone A, Keegan P, Lerakis S, Block PC, Babaliaros V.

Catheter Cardiovasc Interv. 2017 May;89(6):1109-1115. doi: 10.1002/ccd.26875. Epub 2017 Feb 17.

PMID:
28211605
42.

FDA Approval Summary: Pembrolizumab for the Treatment of Patients with Unresectable or Metastatic Melanoma.

Barone A, Hazarika M, Theoret MR, Mishra-Kalyani P, Chen H, He K, Sridhara R, Subramaniam S, Pfuma E, Wang Y, Li H, Zhao H, Zirkelbach JF, Keegan P, Pazdur R.

Clin Cancer Res. 2017 Oct 1;23(19):5661-5665. doi: 10.1158/1078-0432.CCR-16-0664. Epub 2017 Feb 8.

43.

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.

44.

U.S. FDA Approval Summary: Nivolumab for Treatment of Unresectable or Metastatic Melanoma Following Progression on Ipilimumab.

Hazarika M, Chuk MK, Theoret MR, Mushti S, He K, Weis SL, Putman AH, Helms WS, Cao X, Li H, Zhao H, Zhao L, Welch J, Graham L, Libeg M, Sridhara R, Keegan P, Pazdur R.

Clin Cancer Res. 2017 Jul 15;23(14):3484-3488. doi: 10.1158/1078-0432.CCR-16-0712. Epub 2017 Jan 13.

45.

FDA Approval of Nivolumab for the First-Line Treatment of Patients with BRAFV600 Wild-Type Unresectable or Metastatic Melanoma.

Beaver JA, Theoret MR, Mushti S, He K, Libeg M, Goldberg K, Sridhara R, McKee AE, Keegan P, Pazdur R.

Clin Cancer Res. 2017 Jul 15;23(14):3479-3483. doi: 10.1158/1078-0432.CCR-16-0714. Epub 2017 Jan 10.

46.

FDA Approval Summary: Sonidegib for Locally Advanced Basal Cell Carcinoma.

Casey D, Demko S, Shord S, Zhao H, Chen H, He K, Putman A, Helms W, Keegan P, Pazdur R.

Clin Cancer Res. 2017 May 15;23(10):2377-2381. doi: 10.1158/1078-0432.CCR-16-2051. Epub 2017 Jan 10.

47.

FDA's Approach to Regulating Biosimilars.

Lemery SJ, Ricci MS, Keegan P, McKee AE, Pazdur R.

Clin Cancer Res. 2017 Apr 15;23(8):1882-1885. doi: 10.1158/1078-0432.CCR-16-1354. Epub 2016 Dec 29.

48.

Osimertinib for the Treatment of Metastatic EGFR T790M Mutation-Positive Non-Small Cell Lung Cancer.

Khozin S, Weinstock C, Blumenthal GM, Cheng J, He K, Zhuang L, Zhao H, Charlab R, Fan I, Keegan P, Pazdur R.

Clin Cancer Res. 2017 May 1;23(9):2131-2135. doi: 10.1158/1078-0432.CCR-16-1773. Epub 2016 Dec 6.

49.

Does minimalist transfemoral transcatheter aortic valve replacement produce better survival in patients with severe chronic obstructive pulmonary disease?

Condado JF, Haider MN, Lerakis S, Keegan P, Caughron H, Thourani VH, Devireddy C, Leshnower B, Mavromatis K, Sarin EL, Stewart J, Guyton R, Forcillo J, Patel A, Simone A, Block PC, Babaliaros V.

Catheter Cardiovasc Interv. 2017 Mar 1;89(4):775-780. doi: 10.1002/ccd.26683. Epub 2016 Nov 12.

PMID:
27862901
50.

Statistical Considerations in Evaluating a Biosimilar Product in an Oncology Clinical Study.

He K, Chen H, Gwise T, Casak S, Lemery S, Keegan P, Pazdur R, Sridhara R.

Clin Cancer Res. 2016 Nov 1;22(21):5167-5170. Epub 2016 Aug 31.

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