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Items: 1 to 50 of 416

1.

Analysis of the Association Between Adverse Events and Outcome in Patients Receiving a Programmed Death Protein 1 or Programmed Death Ligand 1 Antibody.

Maher VE, Fernandes LL, Weinstock C, Tang S, Agarwal S, Brave M, Ning YM, Singh H, Suzman D, Xu J, Goldberg KB, Sridhara R, Ibrahim A, Theoret M, Beaver JA, Pazdur R.

J Clin Oncol. 2019 May 22:JCO1900318. doi: 10.1200/JCO.19.00318. [Epub ahead of print]

PMID:
31116675
2.

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 May 7. pii: clincanres.0365.2019. doi: 10.1158/1078-0432.CCR-19-0365. [Epub ahead of print]

PMID:
31064779
3.

U.S. Food and Drug Administration Benefit-Risk Assessment of Nilotinib Treatment Discontinuation in Patients with Chronic Phase Chronic Myeloid Leukemia in a Sustained Molecular Remission.

Pulte ED, Wroblewski T, Bloomquist E, Tang S, Farrell A, Deisseroth A, McKee AE, Pazdur R.

Oncologist. 2019 May;24(5):e188-e195. doi: 10.1634/theoncologist.2018-0759. Epub 2019 Apr 24.

PMID:
31019020
4.

Using a Benefit-Risk Analysis Approach to Capture Regulatory Decision Making: Melanoma.

Raju GK, Gurumurthi K, Domike R, Theoret MR, Pazdur R, Woodcock J.

Clin Pharmacol Ther. 2019 Apr 16. doi: 10.1002/cpt.1461. [Epub ahead of print]

PMID:
30993685
5.

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.

PMID:
30914464
6.

Analysis of Time to Treatment Discontinuation of Targeted Therapy, Immunotherapy, and Chemotherapy in clinical trials of patients with non-small cell lung cancer.

Blumenthal GM, Gong Y, Kehl K, Mishra-Kalyani P, Goldberg KB, Khozin S, Kluetz PG, Oxnard GR, Pazdur R.

Ann Oncol. 2019 Feb 22. pii: mdz060. doi: 10.1093/annonc/mdz060. [Epub ahead of print]

PMID:
30796424
7.

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 Feb 20. pii: clincanres.4070.2018. doi: 10.1158/1078-0432.CCR-18-4070. [Epub ahead of print]

PMID:
30787022
8.

Residual Disease after Neoadjuvant Therapy - Developing Drugs for High-Risk Early Breast Cancer.

Prowell TM, Beaver JA, Pazdur R.

N Engl J Med. 2019 Feb 14;380(7):612-615. doi: 10.1056/NEJMp1900079. No abstract available.

PMID:
30763188
9.

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 Jan 28. doi: 10.1158/1078-0432.CCR-18-3749. [Epub ahead of print] Review.

PMID:
30692099
10.

Approvals in 2018: a histology-agnostic new molecular entity, novel end points and real-time review.

Blumenthal GM, Pazdur R.

Nat Rev Clin Oncol. 2019 Mar;16(3):139-141. doi: 10.1038/s41571-019-0170-z. No abstract available.

PMID:
30670830
11.

Real-World Outcomes of Patients with Metastatic Non-Small Cell Lung Cancer Treated with Programmed Cell Death Protein 1 Inhibitors in the Year Following U.S. Regulatory Approval.

Khozin S, Carson KR, Zhi J, Tucker M, Lee SE, Light DE, Curtis MD, Bralic M, Kaganman I, Gossai A, Hofmeister P, Torres AZ, Miksad RA, Blumenthal GM, Pazdur R, Abernethy AP.

Oncologist. 2019 May;24(5):648-656. doi: 10.1634/theoncologist.2018-0307. Epub 2018 Dec 27.

PMID:
30591549
12.

FDA Approval Summary: Pertuzumab for Adjuvant Treatment of HER2-Positive Early Breast Cancer.

Howie LJ, Scher NS, Amiri-Kordestani L, Zhang L, King-Kallimanis BL, Choudhry Y, Schroeder J, Goldberg KB, Kluetz PG, Ibrahim A, Sridhara R, Blumenthal GM, Pazdur R, Beaver JA.

Clin Cancer Res. 2019 May 15;25(10):2949-2955. doi: 10.1158/1078-0432.CCR-18-3003. Epub 2018 Dec 14.

PMID:
30552112
13.

FDA Approval Summary: Atezolizumab or Pembrolizumab for the Treatment of Patients with Advanced Urothelial Carcinoma Ineligible for Cisplatin-Containing Chemotherapy.

Suzman DL, Agrawal S, Ning YM, Maher VE, Fernandes LL, Karuri S, Tang S, Sridhara R, Schroeder J, Goldberg KB, Ibrahim A, McKee AE, Pazdur R, Beaver JA.

Oncologist. 2019 Apr;24(4):563-569. doi: 10.1634/theoncologist.2018-0084. Epub 2018 Dec 12.

PMID:
30541754
14.

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
15.

FDA Approval Summary: Axicabtagene Ciloleucel for Relapsed or Refractory Large B-cell Lymphoma.

Bouchkouj N, Kasamon YL, de Claro RA, George B, Lin X, Lee S, Blumenthal GM, Bryan W, McKee AE, Pazdur R.

Clin Cancer Res. 2019 Mar 15;25(6):1702-1708. doi: 10.1158/1078-0432.CCR-18-2743. Epub 2018 Nov 9.

PMID:
30413526
16.

Immunotherapy Combinations in Multiple Myeloma - Known Unknowns.

Gormley NJ, Pazdur R.

N Engl J Med. 2018 Nov 8;379(19):1791-1795. doi: 10.1056/NEJMp1803602. No abstract available.

PMID:
30403935
17.

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
18.

FDA Approval Summary: Tisagenlecleucel for Treatment of Patients with Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia.

O'Leary MC, Lu X, Huang Y, Lin X, Mahmood I, Przepiorka D, Gavin D, Lee S, Liu K, George B, Bryan W, Theoret MR, Pazdur R.

Clin Cancer Res. 2019 Feb 15;25(4):1142-1146. doi: 10.1158/1078-0432.CCR-18-2035. Epub 2018 Oct 11.

PMID:
30309857
19.

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
20.

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.

21.

FDA Approval Summary: Vemurafenib for the Treatment of Patients with Erdheim-Chester Disease with the BRAFV600 Mutation.

Oneal PA, Kwitkowski V, Luo L, Shen YL, Subramaniam S, Shord S, Goldberg KB, McKee AE, Kaminskas E, Farrell A, Pazdur R.

Oncologist. 2018 Dec;23(12):1520-1524. doi: 10.1634/theoncologist.2018-0295. Epub 2018 Aug 17.

PMID:
30120160
22.

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.

PMID:
30115735
23.

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
24.

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.

25.

Metastasis-free Survival - A New End Point in Prostate Cancer Trials.

Beaver JA, Kluetz PG, Pazdur R.

N Engl J Med. 2018 Jun 28;378(26):2458-2460. doi: 10.1056/NEJMp1805966. No abstract available.

PMID:
29949489
26.

The First Year of the Food and Drug Administration Oncology Center of Excellence: Landmark Approvals in a Dynamic Regulatory Environment.

Goldberg KB, Blumenthal GM, Pazdur R.

Cancer J. 2018 May/Jun;24(3):131-135. doi: 10.1097/PPO.0000000000000316. Review.

PMID:
29794538
27.

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.

PMID:
29743182
28.

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
29.

FDA Approval Summary: Niraparib for the Maintenance Treatment of Patients with Recurrent Ovarian Cancer in Response to Platinum-Based Chemotherapy.

Ison G, Howie LJ, Amiri-Kordestani L, Zhang L, Tang S, Sridhara R, Pierre V, Charlab R, Ramamoorthy A, Song P, Li F, Yu J, Manheng W, Palmby TR, Ghosh S, Horne HN, Lee EY, Philip R, Dave K, Chen XH, Kelly SL, Janoria KG, Banerjee A, Eradiri O, Dinin J, Goldberg KB, Pierce WF, Ibrahim A, Kluetz PG, Blumenthal GM, Beaver JA, Pazdur R.

Clin Cancer Res. 2018 Sep 1;24(17):4066-4071. doi: 10.1158/1078-0432.CCR-18-0042. Epub 2018 Apr 12.

PMID:
29650751
30.

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.

PMID:
29650683
31.

INFORMED: an incubator at the US FDA for driving innovations in data science and agile technology.

Khozin S, Pazdur R, Shah A.

Nat Rev Drug Discov. 2018 Aug;17(8):529-530. doi: 10.1038/nrd.2018.34. Epub 2018 Apr 6. No abstract available.

PMID:
29622786
32.

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.

33.

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.

34.

U.S. Food and Drug Administration Approval: Neratinib for the Extended Adjuvant Treatment of Early-Stage HER2-Positive Breast Cancer.

Singh H, Walker AJ, Amiri-Kordestani L, Cheng J, Tang S, Balcazar P, Barnett-Ringgold K, Palmby TR, Cao X, Zheng N, Liu Q, Yu J, Pierce WF, Daniels SR, Sridhara R, Ibrahim A, Kluetz PG, Blumenthal GM, Beaver JA, Pazdur R.

Clin Cancer Res. 2018 Aug 1;24(15):3486-3491. doi: 10.1158/1078-0432.CCR-17-3628. Epub 2018 Mar 9.

PMID:
29523624
35.

US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments.

Wedam SB, Beaver JA, Amiri-Kordestani L, Bloomquist E, Tang S, Goldberg KB, Sridhara R, Ibrahim A, Kim G, Kluetz P, McKee A, Pazdur R.

J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9.

36.

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.

PMID:
29494733
37.

Leveraging the Success of HIV Drug Development Paradigms for Cancer.

Blumenthal GM, Birnkrant D, Pazdur R.

Clin Cancer Res. 2018 Jun 1;24(11):2491-2492. doi: 10.1158/1078-0432.CCR-18-0544. Epub 2018 Feb 28. No abstract available.

PMID:
29490988
38.

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.

PMID:
29476018
39.

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.

40.

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.

41.

FDA Approval: Ribociclib for the Treatment of Postmenopausal Women with Hormone Receptor-Positive, HER2-Negative Advanced or Metastatic Breast Cancer.

Shah A, Bloomquist E, Tang S, Fu W, Bi Y, Liu Q, Yu J, Zhao P, Palmby TR, Goldberg KB, Chang CJG, Patel P, Alebachew E, Tilley A, Pierce WF, Ibrahim A, Blumenthal GM, Sridhara R, Beaver JA, Pazdur R.

Clin Cancer Res. 2018 Jul 1;24(13):2999-3004. doi: 10.1158/1078-0432.CCR-17-2369. Epub 2018 Feb 7.

PMID:
29437768
42.

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.

43.

Approvals in 2017: gene therapies and site-agnostic indications.

Blumenthal GM, Pazdur R.

Nat Rev Clin Oncol. 2018 Mar;15(3):127-128. doi: 10.1038/nrclinonc.2018.11. Epub 2018 Jan 31. No abstract available.

PMID:
29384145
44.

Survival of ethnic and racial minority patients with multiple myeloma treated with newer medications.

Pulte ED, Nie L, Gormley N, Goldberg KB, McKee A, Farrell A, Pazdur R.

Blood Adv. 2018 Jan 23;2(2):116-119. doi: 10.1182/bloodadvances.2017010512. No abstract available.

45.

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.

46.

Characteristics of Real-World Metastatic Non-Small Cell Lung Cancer Patients Treated with Nivolumab and Pembrolizumab During the Year Following Approval.

Khozin S, Abernethy AP, Nussbaum NC, Zhi J, Curtis MD, Tucker M, Lee SE, Light DE, Gossai A, Sorg RA, Torres AZ, Patel P, Blumenthal GM, Pazdur R.

Oncologist. 2018 Mar;23(3):328-336. doi: 10.1634/theoncologist.2017-0353. Epub 2018 Jan 9.

47.

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.

48.

Use of PRO Measures to Inform Tolerability in Oncology Trials: Implications for Clinical Review, IND Safety Reporting, and Clinical Site Inspections.

Kim J, Singh H, Ayalew K, Borror K, Campbell M, Johnson LL, Karesh A, Khin NA, Less JR, Menikoff J, Minasian L, Mitchell SA, Papadopoulos EJ, Piekarz RL, Prohaska KA, Thompson S, Sridhara R, Pazdur R, Kluetz PG.

Clin Cancer Res. 2018 Apr 15;24(8):1780-1784. doi: 10.1158/1078-0432.CCR-17-2555. Epub 2017 Dec 13.

49.

Accelerating Early Access to Immunotherapies for Advanced Urothelial Carcinoma.

Ning YM, Maher VE, Beaver JA, Goldberg KB, Blumenthal GM, Pazdur R.

Oncologist. 2018 Feb;23(2):139-142. doi: 10.1634/theoncologist.2017-0415. Epub 2017 Nov 27. No abstract available.

50.

The FDA Oncology Center of Excellence and precision medicine.

Goldberg KB, Blumenthal GM, McKee AE, Pazdur R.

Exp Biol Med (Maywood). 2018 Feb;243(3):308-312. doi: 10.1177/1535370217740861. Epub 2017 Nov 6. Review.

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