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Cancer drugs approved for use in children: Impact of legislative initiatives and future opportunities.

Barone A, Casey D, McKee AE, Reaman G.

Pediatr Blood Cancer. 2019 Aug;66(8):e27809. doi: 10.1002/pbc.27809. Epub 2019 May 30.


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.


Proceedings of a Workshop: US Food and Drug Administration-International Society of Pharmacometrics Model-Informed Drug Development in Oncology.

Bruno R, Jin JY, Maxfield K, Milligan L, Liu C, Wang Y, McKee AE, Zineh I.

Clin Pharmacol Ther. 2019 Jul;106(1):81-83. doi: 10.1002/cpt.1421. Epub 2019 Apr 5. No abstract available.


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.


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.


Complexity of Delivering Precision Medicine: Opportunities and Challenges.

Davis AA, McKee AE, Kibbe WA, Villaflor VM.

Am Soc Clin Oncol Educ Book. 2018 May 23;38:998-1007. doi: 10.1200/EDBK_200279. Review.


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.


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.


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.


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.


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.


Breakthrough-Therapy Designation - An FDA Perspective.

Corrigan-Curay J, McKee AE, Stein P.

N Engl J Med. 2018 Apr 12;378(15):1457-1458. doi: 10.1056/NEJMc1801222. No abstract available.


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.


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.


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.


Report on the Third FDA-AACR Oncology Dose-Finding Workshop.

Emens LA, Bruno R, Rubin EH, Jaffee EM, McKee AE.

Cancer Immunol Res. 2017 Dec;5(12):1058-1061. doi: 10.1158/2326-6066.CIR-17-0590.


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.


How Often Are Drugs Made Available Under the Food and Drug Administration's Expanded Access Process Approved?

McKee AE, Markon AO, Chan-Tack KM, Lurie P.

J Clin Pharmacol. 2017 Oct;57 Suppl 10:S136-S142. doi: 10.1002/jcph.960. Review.


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.


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.


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.


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.


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.


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.


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.


An FDA Perspective on the Regulatory Implications of Complex Signatures to Predict Response to Targeted Therapies.

Beaver JA, Tzou A, Blumenthal GM, McKee AE, Kim G, Pazdur R, Philip R.

Clin Cancer Res. 2017 Mar 15;23(6):1368-1372. doi: 10.1158/1078-0432.CCR-16-1098. Epub 2016 Dec 19.


FDA Approval: Alectinib for the Treatment of Metastatic, ALK-Positive Non-Small Cell Lung Cancer Following Crizotinib.

Larkins E, Blumenthal GM, Chen H, He K, Agarwal R, Gieser G, Stephens O, Zahalka E, Ringgold K, Helms W, Shord S, Yu J, Zhao H, Davis G, McKee AE, Keegan P, Pazdur R.

Clin Cancer Res. 2016 Nov 1;22(21):5171-5176. Epub 2016 Jul 13.


U.S. Food and Drug Administration Approval: Cabozantinib for the Treatment of Advanced Renal Cell Carcinoma.

Singh H, Brave M, Beaver JA, Cheng J, Tang S, Zahalka E, Palmby TR, Venugopal R, Song P, Liu Q, Liu C, Yu J, Chen XH, Wang X, Wang Y, Kluetz PG, Daniels SR, Papadopoulos EJ, Sridhara R, McKee AE, Ibrahim A, Kim G, Pazdur R.

Clin Cancer Res. 2017 Jan 15;23(2):330-335. doi: 10.1158/1078-0432.CCR-16-1073. Epub 2016 Oct 28.


FDA Approval of Palbociclib in Combination with Fulvestrant for the Treatment of Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer.

Walker AJ, Wedam S, Amiri-Kordestani L, Bloomquist E, Tang S, Sridhara R, Chen W, Palmby TR, Fourie Zirkelbach J, Fu W, Liu Q, Tilley A, Kim G, Kluetz PG, McKee AE, Pazdur R.

Clin Cancer Res. 2016 Oct 15;22(20):4968-4972. Epub 2016 Jul 12.


FDA Approval: Uridine Triacetate for the Treatment of Patients Following Fluorouracil or Capecitabine Overdose or Exhibiting Early-Onset Severe Toxicities Following Administration of These Drugs.

Ison G, Beaver JA, McGuinn WD Jr, Palmby TR, Dinin J, Charlab R, Marathe A, Jin R, Liu Q, Chen XH, Ysern X, Stephens O, Bai G, Wang Y, Dorff SE, Cheng J, Tang S, Sridhara R, Pierce W, McKee AE, Ibrahim A, Kim G, Pazdur R.

Clin Cancer Res. 2016 Sep 15;22(18):4545-9. doi: 10.1158/1078-0432.CCR-16-0638. Epub 2016 Jul 11. Review.


Dose Finding of Small-Molecule Oncology Drugs: Optimization throughout the Development Life Cycle.

Jänne PA, Kim G, Shaw AT, Sridhara R, Pazdur R, McKee AE.

Clin Cancer Res. 2016 Jun 1;22(11):2613-7. doi: 10.1158/1078-0432.CCR-15-2643.


Successes and Challenges of PARP Inhibitors in Cancer Therapy.

Ricks TK, Chiu HJ, Ison G, Kim G, McKee AE, Kluetz P, Pazdur R.

Front Oncol. 2015 Oct 14;5:222. doi: 10.3389/fonc.2015.00222. eCollection 2015. Review. No abstract available.


FDA Approval Summary: Olaparib Monotherapy in Patients with Deleterious Germline BRCA-Mutated Advanced Ovarian Cancer Treated with Three or More Lines of Chemotherapy.

Kim G, Ison G, McKee AE, Zhang H, Tang S, Gwise T, Sridhara R, Lee E, Tzou A, Philip R, Chiu HJ, Ricks TK, Palmby T, Russell AM, Ladouceur G, Pfuma E, Li H, Zhao L, Liu Q, Venugopal R, Ibrahim A, Pazdur R.

Clin Cancer Res. 2015 Oct 1;21(19):4257-61. doi: 10.1158/1078-0432.CCR-15-0887. Epub 2015 Jul 17. Review.


NCCN Working Group report: designing clinical trials in the era of multiple biomarkers and targeted therapies.

Venook AP, Arcila ME, Benson AB 3rd, Berry DA, Camidge DR, Carlson RW, Choueiri TK, Guild V, Kalemkerian GP, Kurzrock R, Lovly CM, McKee AE, Morgan RJ, Olszanski AJ, Redman MW, Stearns V, McClure J, Birkeland ML.

J Natl Compr Canc Netw. 2014 Nov;12(11):1629-49.


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.


Manipulation of the carbon storage regulator system for metabolite remodeling and biofuel production in Escherichia coli.

McKee AE, Rutherford BJ, Chivian DC, Baidoo EK, Juminaga D, Kuo D, Benke PI, Dietrich JA, Ma SM, Arkin AP, Petzold CJ, Adams PD, Keasling JD, Chhabra SR.

Microb Cell Fact. 2012 Jun 13;11:79.


High-throughput metabolic engineering: advances in small-molecule screening and selection.

Dietrich JA, McKee AE, Keasling JD.

Annu Rev Biochem. 2010;79:563-90. doi: 10.1146/annurev-biochem-062608-095938. Review.


The role of the U.S. Food and Drug Administration review process: clinical trial endpoints in oncology.

McKee AE, Farrell AT, Pazdur R, Woodcock J.

Oncologist. 2010;15 Suppl 1:13-8. doi: 10.1634/theoncologist.2010-S1-13.


On Trk--the TrkB signal transduction pathway is an increasingly important target in cancer biology.

Thiele CJ, Li Z, McKee AE.

Clin Cancer Res. 2009 Oct 1;15(19):5962-7. doi: 10.1158/1078-0432.CCR-08-0651. Epub 2009 Sep 15. Review.


Neuroblastoma cells isolated from bone marrow metastases contain a naturally enriched tumor-initiating cell.

Hansford LM, McKee AE, Zhang L, George RE, Gerstle JT, Thorner PS, Smith KM, Look AT, Yeger H, Miller FD, Irwin MS, Thiele CJ, Kaplan DR.

Cancer Res. 2007 Dec 1;67(23):11234-43.


Exon expression profiling reveals stimulus-mediated exon use in neural cells.

McKee AE, Neretti N, Carvalho LE, Meyer CA, Fox EA, Brodsky AS, Silver PA.

Genome Biol. 2007;8(8):R159.


Systems perspectives on mRNA processing.

McKee AE, Silver PA.

Cell Res. 2007 Jul;17(7):581-90. Review.


Targeting caspase 8 to reduce the formation of metastases in neuroblastoma.

McKee AE, Thiele CJ.

Expert Opin Ther Targets. 2006 Oct;10(5):703-8. Review.


Systems biology of gene regulation fulfills its promise.

McKee AE, Silver PA.

Genome Biol. 2006;7(5):316. Epub 2006 May 22. No abstract available.


REF-ereeing the cytoplasmic fate of mRNA via nuclear export.

McKee AE, Silver PA.

Dev Cell. 2004 Jun;6(6):740-2. Review.


Functional cloning of TUG as a regulator of GLUT4 glucose transporter trafficking.

Bogan JS, Hendon N, McKee AE, Tsao TS, Lodish HF.

Nature. 2003 Oct 16;425(6959):727-33.


Mousepox outbreak in a laboratory mouse colony.

Dick EJ Jr, Kittell CL, Meyer H, Farrar PL, Ropp SL, Esposito JJ, Buller RM, Neubauer H, Kang YH, McKee AE.

Lab Anim Sci. 1996 Dec;46(6):602-11.


Effect of lactacidosis on pyridine nucleotide stability during ischemia in mouse brain.

Welsh FA, Sakamoto T, McKee AE, Sims RE.

J Neurochem. 1987 Sep;49(3):846-51.


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