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Items: 1 to 50 of 436

1.

Approvals in 2019: international review and a new agnostic molecular entity.

Singh H, Blumenthal G, Pazdur R.

Nat Rev Clin Oncol. 2020 Feb 11. doi: 10.1038/s41571-020-0336-8. [Epub ahead of print] No abstract available.

PMID:
32047277
2.

FDA Approval Summary: Ruxolitinib for Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease.

Przepiorka D, Luo L, Subramaniam S, Qiu J, Gudi R, Cunningham LC, Nie L, Leong R, Ma L, Sheth C, Deisseroth A, Goldberg KB, Blumenthal GM, Pazdur R.

Oncologist. 2020 Feb;25(2):e328-e334. doi: 10.1634/theoncologist.2019-0627. Epub 2019 Oct 22.

3.

FDA Approval Summary: Atezolizumab plus paclitaxel protein-bound for the treatment of patients with advanced or metastatic TNBC whose tumors express PD-L1.

Narayan P, Wahby S, Gao JJ, Amiri-Kordestani L, Ibrahim A, Bloomquist E, Tang S, Xu Y, Liu J, Fu W, Song P, King-Kallimanis BL, Hou S, Gong Y, Kalavar S, Ghosh S, Philip R, Goldberg KB, Theoret MR, Blumenthal GM, Kluetz PG, Sridhara R, Pazdur R, Beaver JA.

Clin Cancer Res. 2020 Jan 30. pii: clincanres.3545.2019. doi: 10.1158/1078-0432.CCR-19-3545. [Epub ahead of print]

PMID:
32001481
4.

CDK4/6 inhibitor treatment for patients with hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer: a US Food and Drug Administration pooled analysis.

Gao JJ, Cheng J, Bloomquist E, Sanchez J, Wedam SB, Singh H, Amiri-Kordestani L, Ibrahim A, Sridhara R, Goldberg KB, Theoret MR, Kluetz PG, Blumenthal GM, Pazdur R, Beaver JA, Prowell TM.

Lancet Oncol. 2020 Feb;21(2):250-260. doi: 10.1016/S1470-2045(19)30804-6. Epub 2019 Dec 16.

PMID:
31859246
5.

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]

6.

An Analysis of Recent FDA Oncology Scientific Publications.

Schneider JA, Miklos AC, Onken J, Gong Y, Calcagno AM, Blumenthal GM, Aragon R, Pazdur R.

Oncologist. 2019 Nov 26. pii: theoncologist.2019-0503. doi: 10.1634/theoncologist.2019-0503. [Epub ahead of print]

7.

Eligibility and Radiologic Assessment for Adjuvant Clinical Trials in Kidney Cancer.

Agrawal S, Haas NB, Bagheri M, Lane BR, Coleman J, Hammers H, Bratslavsky G, Chauhan C, Kim L, Krishnasamy VP, Marko J, Maher VE, Ibrahim A, Cross F Jr, Liu K, Beaver JA, Pazdur R, Blumenthal GM, Singh H, Plimack ER, Choueiri TK, Uzzo R, Apolo AB.

JAMA Oncol. 2019 Nov 21. doi: 10.1001/jamaoncol.2019.4117. [Epub ahead of print]

PMID:
31750870
8.

Reply to H. McLeod et al.

Weinstock C, Fernandes LL, Theoret M, Tang S, Sridhara R, Beaver JA, Pazdur R.

J Clin Oncol. 2020 Jan 1;38(1):106. doi: 10.1200/JCO.19.02429. Epub 2019 Nov 1. No abstract available.

PMID:
31675249
9.

Eligibility and Radiologic Assessment in Adjuvant Clinical Trials in Bladder Cancer.

Apolo AB, Milowsky MI, Kim L, Inman BA, Kamat AM, Steinberg G, Bagheri M, Krishnasamy VP, Marko J, Dinney CP, Bangs R, Sweis RF, Maher VE, Ibrahim A, Liu K, Werntz R, Cross F, Beaver JA, Singh H, Pazdur R, Blumenthal GM, Lerner SP, Bajorin DF, Rosenberg JE, Agrawal S.

JAMA Oncol. 2019 Oct 31:1-9. doi: 10.1001/jamaoncol.2019.4114. [Epub ahead of print]

PMID:
31670753
10.

FDA Approval Summary: Palbociclib for Male Patients with Metastatic Breast Cancer.

Wedam S, Fashoyin-Aje L, Bloomquist E, Tang S, Sridhara R, Goldberg KB, Theoret MR, Amiri-Kordestani L, Pazdur R, Beaver JA.

Clin Cancer Res. 2019 Oct 24. doi: 10.1158/1078-0432.CCR-19-2580. [Epub ahead of print]

PMID:
31649043
11.

FDA Approval Summary: Ruxolitinib for Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease.

Przepiorka D, Luo L, Subramaniam S, Qiu J, Gudi R, Cunningham LC, Nie L, Leong R, Ma L, Sheth C, Deisseroth A, Goldberg KB, Blumenthal GM, Pazdur R.

Oncologist. 2019 Oct 22. pii: theoncologist.2019-0627. doi: 10.1634/theoncologist.2019-0627. [Epub ahead of print]

12.

Outcomes of Older Women With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor-Negative Metastatic Breast Cancer Treated With a CDK4/6 Inhibitor and an Aromatase Inhibitor: An FDA Pooled Analysis.

Howie LJ, Singh H, Bloomquist E, Wedam S, Amiri-Kordestani L, Tang S, Sridhara R, Sanchez J, Prowell TM, Kluetz PG, King-Kallimanis BL, Gao JJ, Ibrahim A, Goldberg KB, Theoret M, Pazdur R, Beaver JA.

J Clin Oncol. 2019 Dec 20;37(36):3475-3483. doi: 10.1200/JCO.18.02217. Epub 2019 Sep 27.

PMID:
31560580
13.

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. 2020 Feb 1;26(3):532-536. doi: 10.1158/1078-0432.CCR-19-2329. Epub 2019 Sep 23.

PMID:
31548341
14.

Global Variation in Opioid Use in Prostate Cancer Trials.

Roydhouse JK, Suzman DL, Menapace LA, Mishra-Kalyani PS, Sridhara R, Blumenthal GM, Beaver JA, Pazdur R, Kluetz PG.

JAMA Oncol. 2019 Sep 12:e192971. doi: 10.1001/jamaoncol.2019.2971. [Epub ahead of print]

PMID:
31513232
15.

Development of Treatments for Localized Prostate Cancer in Patients Eligible for Active Surveillance: U.S. Food and Drug Administration Oncology Center of Excellence Public Workshop.

Weinstock C, Suzman D, Kluetz P, Baxley J, Viviano C, Ibrahim A, Jarow J, Sridhara R, Liu K, Carroll P, Eggener S, Hu JC, Hussain M, King M, Klein E, Kungel T, Makarov D, Pinto PA, Rini B, Roach M, Sandler H, Schlegel PN, Song D, Goldberg K, Pazdur R, Beaver JA.

J Urol. 2020 Jan;203(1):115-119. doi: 10.1097/JU.0000000000000532. Epub 2019 Sep 10.

PMID:
31502940
16.

FDA Approval Summary: Calaspargase Pegol-mknl For Treatment of Acute Lymphoblastic Leukemia in Children and Young Adults.

Li RJ, Jin R, Liu C, Cao X, Manning ML, Di XM, Przepiorka D, Namuswe F, Deisseroth A, Goldberg KB, Blumenthal GM, Pazdur R.

Clin Cancer Res. 2020 Jan 15;26(2):328-331. doi: 10.1158/1078-0432.CCR-19-1255. Epub 2019 Aug 23.

PMID:
31444252
17.

Real-world progression, treatment, and survival outcomes during rapid adoption of immunotherapy for advanced non-small cell lung cancer.

Khozin S, Miksad RA, Adami J, Boyd M, Brown NR, Gossai A, Kaganman I, Kuk D, Rockland JM, Pazdur R, Torres AZ, Zhi J, Abernethy AP.

Cancer. 2019 Nov 15;125(22):4019-4032. doi: 10.1002/cncr.32383. Epub 2019 Aug 5.

18.

FDA Approval Summary: Mogamulizumab-kpkc for Mycosis Fungoides and Sézary Syndrome.

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

Clin Cancer Res. 2019 Dec 15;25(24):7275-7280. doi: 10.1158/1078-0432.CCR-19-2030. Epub 2019 Jul 31.

PMID:
31366601
19.

Using a Benefit-Risk Analysis Approach to Capture Regulatory Decision Making: Renal Cell Carcinoma.

Raju GK, Gurumurthi K, Domike R, Singh H, Weinstock C, Kluetz P, Pazdur R, Woodcock J.

Clin Pharmacol Ther. 2020 Mar;107(3):495-506. doi: 10.1002/cpt.1589. Epub 2019 Sep 27.

PMID:
31355920
20.

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
21.

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 Oct 20;37(30):2730-2737. doi: 10.1200/JCO.19.00318. Epub 2019 May 22.

PMID:
31116675
22.

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
23.

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.

24.

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 Jul;106(1):123-135. doi: 10.1002/cpt.1461. Epub 2019 May 21.

PMID:
30993685
25.

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.

26.

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 May 1;30(5):830-838. doi: 10.1093/annonc/mdz060.

27.

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
28.

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
29.

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
30.

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
31.

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.

32.

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
33.

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.

34.

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
35.

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
36.

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
37.

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
38.

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.

39.

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.

40.

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.

41.

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.

42.

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.

43.

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
44.

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.

45.

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
46.

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
47.

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.

48.

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
49.

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.

50.

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.

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