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Items: 1 to 50 of 389

1.

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):127-131. doi: 10.1097/PPO.0000000000000316.

PMID:
29794538
2.

FDA's Approval of the FirstĀ  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 May 9. pii: clincanres.0566.2018. doi: 10.1158/1078-0432.CCR-18-0566. [Epub ahead of print]

PMID:
29743182
3.

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
4.

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 Apr 12. pii: clincanres.0042.2018. doi: 10.1158/1078-0432.CCR-18-0042. [Epub ahead of print]

PMID:
29650751
5.

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 Apr 12. pii: theoncologist.2017-0604. doi: 10.1634/theoncologist.2017-0604. [Epub ahead of print]

PMID:
29650683
6.

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 Apr 6. doi: 10.1038/nrd.2018.34. [Epub ahead of print] No abstract available.

PMID:
29622786
7.

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 Apr 5. pii: theoncologist.2018-0028. doi: 10.1634/theoncologist.2018-0028. [Epub ahead of print]

PMID:
29622697
8.

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. 2018 Feb 26. doi: 10.1093/annonc/mdy045. [Epub ahead of print] No abstract available.

PMID:
29529128
9.

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 Mar 9. pii: clincanres.3628.2017. doi: 10.1158/1078-0432.CCR-17-3628. [Epub ahead of print]

PMID:
29523624
10.

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.

PMID:
29522361
11.

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
12.

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
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 Feb 23. doi: 10.1158/1078-0432.CCR-17-3179. [Epub ahead of print]

PMID:
29476018
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.

PMID:
29438096
15.

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.

PMID:
29438093
16.

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 Feb 7. doi: 10.1158/1078-0432.CCR-17-2369. [Epub ahead of print]

PMID:
29437768
17.

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.

18.

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
19.

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.

20.

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.

PMID:
29361469
21.

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.

PMID:
29317551
22.

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.

23.

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.

PMID:
29237718
24.

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.

25.

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.

PMID:
29105511
26.

Real-world Data for Clinical Evidence Generation in Oncology.

Khozin S, Blumenthal GM, Pazdur R.

J Natl Cancer Inst. 2017 Nov 1;109(11). doi: 10.1093/jnci/djx187.

PMID:
29059439
27.

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.

PMID:
29045514
28.

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
29.

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.

PMID:
28972086
30.

Re-Evaluating Eligibility Criteria for Oncology Clinical Trials: Analysis of Investigational New Drug Applications in 2015.

Jin S, Pazdur R, Sridhara R.

J Clin Oncol. 2017 Nov 20;35(33):3745-3752. doi: 10.1200/JCO.2017.73.4186. Epub 2017 Oct 2.

PMID:
28968168
31.

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.

32.

A Benefit-Risk Analysis Approach to Capture Regulatory Decision-Making: Multiple Myeloma.

Raju GK, Gurumurthi K, Domike R, Kazandjian D, Landgren O, Blumenthal GM, Farrell A, Pazdur R, Woodcock J.

Clin Pharmacol Ther. 2018 Jan;103(1):67-76. doi: 10.1002/cpt.871. Epub 2017 Nov 20. Review.

PMID:
28901535
33.

FDA ovarian cancer clinical trial endpoints workshop: A Society of Gynecologic Oncology White Paper.

Herzog TJ, Ison G, Alvarez RD, Balasubramaniam S, Armstrong DK, Beaver JA, Ellis A, Tang S, Ford P, McKee A, Gershenson DM, Kim G, Monk BJ, Pazdur R, Coleman RL.

Gynecol Oncol. 2017 Oct;147(1):3-10. doi: 10.1016/j.ygyno.2017.08.012. Epub 2017 Aug 24. Review. No abstract available.

PMID:
28844539
34.

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.

35.

Setting the Record Straight on FDA Approvals in Oncology.

Blumenthal G, Kim G, Pazdur R.

JAMA Intern Med. 2017 Aug 1;177(8):1222. doi: 10.1001/jamainternmed.2017.2241. No abstract available.

PMID:
28783827
36.

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.

PMID:
28774898
37.

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.

PMID:
28774876
38.

FDA Approval Summary: Rucaparib for the Treatment of Patients with Deleterious BRCA Mutation-Associated Advanced Ovarian Cancer.

Balasubramaniam S, Beaver JA, Horton S, Fernandes LL, Tang S, Horne HN, Liu J, Liu C, Schrieber SJ, Yu J, Song P, Pierce W, Robertson KJ, Palmby TR, Chiu HJ, Lee EY, Philip R, Schuck R, Charlab R, Banerjee A, Chen XH, Wang X, Goldberg KB, Sridhara R, Kim G, Pazdur R.

Clin Cancer Res. 2017 Dec 1;23(23):7165-7170. doi: 10.1158/1078-0432.CCR-17-1337. Epub 2017 Jul 27.

PMID:
28751443
39.

Treatment Beyond Progression With Immune Checkpoint Inhibitors-Known Unknowns.

Blumenthal GM, Theoret MR, Pazdur R.

JAMA Oncol. 2017 Nov 1;3(11):1473-1474. doi: 10.1001/jamaoncol.2017.1819. No abstract available.

PMID:
28662228
40.

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
41.

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.

42.

U.S. Food and Drug Administration Approval Summary: Atezolizumab for Metastatic Non-Small Cell Lung Cancer.

Weinstock C, Khozin S, Suzman D, Zhang L, Tang S, Wahby S, Goldberg KB, Kim G, Pazdur R.

Clin Cancer Res. 2017 Aug 15;23(16):4534-4539. doi: 10.1158/1078-0432.CCR-17-0540. Epub 2017 Jun 13.

PMID:
28611199
43.

Clinical Development of Cancer Drugs in Combination With External Beam Radiation Therapy: US Food and Drug Administration Perspective.

Walker AJ, Kim H, Saber H, Kluetz PG, Kim G, Pazdur R.

Int J Radiat Oncol Biol Phys. 2017 May 1;98(1):5-7. doi: 10.1016/j.ijrobp.2016.12.037. No abstract available.

PMID:
28587052
44.

Oncology Drug Approvals: Evaluating Endpoints and Evidence in an Era of Breakthrough Therapies.

Blumenthal GM, Kluetz PG, Schneider J, Goldberg KB, McKee AE, Pazdur R.

Oncologist. 2017 Jul;22(7):762-767. doi: 10.1634/theoncologist.2017-0152. Epub 2017 Jun 2. No abstract available.

45.

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.

46.

Regulatory considerations on endpoints in ovarian cancer drug development.

Balasubramaniam S, Kim GS, McKee AE, Pazdur R.

Cancer. 2017 Jul 15;123(14):2604-2608. doi: 10.1002/cncr.30652. Epub 2017 May 12. Review.

PMID:
28499075
47.

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.

48.

FDA Approval Summary: Atezolizumab for the Treatment of Patients with Progressive Advanced Urothelial Carcinoma after Platinum-Containing Chemotherapy.

Ning YM, Suzman D, Maher VE, Zhang L, Tang S, Ricks T, Palmby T, Fu W, Liu Q, Goldberg KB, Kim G, Pazdur R.

Oncologist. 2017 Jun;22(6):743-749. doi: 10.1634/theoncologist.2017-0087. Epub 2017 Apr 19.

49.

Reevaluating Eligibility Criteria - Balancing Patient Protection and Participation in Oncology Trials.

Beaver JA, Ison G, Pazdur R.

N Engl J Med. 2017 Apr 20;376(16):1504-1505. doi: 10.1056/NEJMp1615879. No abstract available.

PMID:
28423289
50.

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

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