Publications by authors named "Rajeshwari Sridhara"

100Publications

Immune Response Evaluation and Treatment with Immune Checkpoint Inhibitors Beyond Clinical Progression: Response Assessments for Cancer Immunotherapy.

Curr Oncol Rep 2020 Aug 27;22(11):116. Epub 2020 Aug 27.

Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.

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http://dx.doi.org/10.1007/s11912-020-00974-zDOI Listing
August 2020

An Empirical Investigation of Bayesian Clinical Trial Design in Metastatic Breast Cancer.

Ther Innov Regul Sci 2020 07 10;54(4):861-869. Epub 2019 Dec 10.

Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.

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http://dx.doi.org/10.1007/s43441-019-00002-8DOI Listing
July 2020

A Bayesian approach in design and analysis of pediatric cancer clinical trials.

Pharm Stat 2020 Jun 14. Epub 2020 Jun 14.

Division of Biometrics V, Office of Biostatistics, Office of Translational Sciences, Center of Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.

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http://dx.doi.org/10.1002/pst.2039DOI Listing
June 2020

An FDA Review of Drug Development in Nonmetastatic Castration-resistant Prostate Cancer.

Clin Cancer Res 2020 Sep 13;26(18):4717-4722. Epub 2020 Apr 13.

Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

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http://dx.doi.org/10.1158/1078-0432.CCR-19-3835DOI Listing
September 2020

Comparison of iRECIST versus RECIST V.1.1 in patients treated with an anti-PD-1 or PD-L1 antibody: pooled FDA analysis.

J Immunother Cancer 2020 02;8(1)

CDER/Office of Translational Sciences, US Food and Drug Administration, Silver Spring, Maryland, USA.

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http://dx.doi.org/10.1136/jitc-2019-000146DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7057528PMC
February 2020

Reply to H. McLeod et al.

J Clin Oncol 2020 01 1;38(1):106. Epub 2019 Nov 1.

Chana Weinstock, MD; Laura L. Fernandes, PhD; Marc Theoret, MD; Shenghui Tang, PhD; Rajeshwari Sridhara, PhD; Julia A. Beaver, MD; and Richard Pazdur, MD, US Food and Drug Administration, Silver Spring, MD.

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http://dx.doi.org/10.1200/JCO.19.02429DOI Listing
January 2020

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

Clin Cancer Res 2020 Mar 24;26(6):1208-1212. Epub 2019 Oct 24.

Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

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http://dx.doi.org/10.1158/1078-0432.CCR-19-2580DOI Listing
March 2020

US Food and Drug Administration review of statistical analysis of patient-reported outcomes in lung cancer clinical trials approved between January, 2008, and December, 2017.

Lancet Oncol 2019 10 30;20(10):e582-e589. Epub 2019 Sep 30.

Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

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http://dx.doi.org/10.1016/S1470-2045(19)30335-3DOI Listing
October 2019

Global Variation in Opioid Use in Prostate Cancer Trials.

JAMA Oncol 2019 Sep 12:e192971. Epub 2019 Sep 12.

Oncology Center of Excellence, Food and Drug Administration, Silver Spring, Maryland.

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http://dx.doi.org/10.1001/jamaoncol.2019.2971DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6743059PMC
September 2019

Analyzing patient-reported outcome data when completion differs between arms in open-label trials: an application of principal stratification.

Pharmacoepidemiol Drug Saf 2019 10 13;28(10):1386-1394. Epub 2019 Aug 13.

Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

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http://dx.doi.org/10.1002/pds.4875DOI Listing
October 2019

FDA Approval: Blinatumomab for Patients with B-cell Precursor Acute Lymphoblastic Leukemia in Morphologic Remission with Minimal Residual Disease.

Clin Cancer Res 2019 01 25;25(2):473-477. Epub 2018 Sep 25.

Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

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http://dx.doi.org/10.1158/1078-0432.CCR-18-2337DOI Listing
January 2019

Dose Finding in Late-Phase Drug Development.

Ther Innov Regul Sci 2017 Nov 30;51(6):738-743. Epub 2017 May 30.

1 Office of Biostatistics/CDER/FDA, Silver Spring, MD, USA.

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http://dx.doi.org/10.1177/2168479017709297DOI Listing
November 2017

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

J Natl Cancer Inst 2019 05;111(5):449-458

Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration.

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http://dx.doi.org/10.1093/jnci/djy130DOI Listing
May 2019

Unresectable and Metastatic Melanoma of the Skin: Literature Review of Clinical Trials and Efficacy Endpoints Since 2000.

Ther Innov Regul Sci 2019 01 24;53(1):59-70. Epub 2018 Apr 24.

1 Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

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http://dx.doi.org/10.1177/2168479018769286DOI Listing
January 2019

Evaluation of Overall Response Rate and Progression-Free Survival as Potential Surrogate Endpoints for Overall Survival in Immunotherapy Trials.

Clin Cancer Res 2018 05 11;24(10):2268-2275. Epub 2018 Jan 11.

Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

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http://clincancerres.aacrjournals.org/lookup/doi/10.1158/107
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http://dx.doi.org/10.1158/1078-0432.CCR-17-1902DOI Listing
May 2018

Exploration of a Novel Intermediate Response Endpoint in Immunotherapy Clinical Studies.

Clin Cancer Res 2018 05 26;24(10):2262-2267. Epub 2017 Dec 26.

Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

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http://dx.doi.org/10.1158/1078-0432.CCR-17-2111DOI Listing
May 2018

Broadening Eligibility Criteria to Make Clinical Trials More Representative: American Society of Clinical Oncology and Friends of Cancer Research Joint Research Statement.

J Clin Oncol 2017 Nov 2;35(33):3737-3744. Epub 2017 Oct 2.

Edward S. Kim, Levine Cancer Institute, Carolinas HealthCare System, Charlotte, NC; Suanna S. Bruinooge, Caroline Schenkel, and Richard L. Schilsky, ASCO, Alexandria, VA; Samantha Roberts, Marina Kozak, Jeff Allen, and Ellen Sigal, Friends of Cancer Research; Samantha Roberts, Genentech, Washington, DC; Gwynn Ison, Julia A. Beaver, Rajeshwari Sridhara, and Tatiana M. Prowell, US Food and Drug Administration, Silver Spring; Thomas S. Uldrick and Andrea M. Denicoff, National Cancer Institute, Bethesda, MD; Nancy U. Lin, Dana-Farber Cancer Institute, Boston; Paul J. Hesketh, Lahey Health Cancer Institute, Burlington, MA; Lia Gore, University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO; Stuart M. Lichtman, Memorial Sloan-Kettering Cancer Center, New York, NY; Nancy Roach, Fight Colorectal Cancer, Springfield, MO; Elizabeth Garrett-Mayer, Hollings Cancer Center, Medical University of South Carolina, Charleston, SC; Eric Rubin, Merck Research Laboratories, Kenilworth, NJ; and Pratik Multani, Ignyta, San Diego, CA.

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http://dx.doi.org/10.1200/JCO.2017.73.7916DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5692724PMC
November 2017

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

J Clin Oncol 2017 Nov 2;35(33):3745-3752. Epub 2017 Oct 2.

All authors: US Food and Drug Administration, Silver Spring, MD.

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http://dx.doi.org/10.1200/JCO.2017.73.4186DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5692723PMC
November 2017

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

Clin Cancer Res 2017 Oct 8;23(19):5661-5665. Epub 2017 Feb 8.

Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

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http://dx.doi.org/10.1158/1078-0432.CCR-16-0664DOI Listing
October 2017

Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials-Response.

Clin Cancer Res 2016 11;22(22):5618

Office of Hematology and Oncology Products, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

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http://dx.doi.org/10.1158/1078-0432.CCR-16-2140DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5895452PMC
November 2016

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

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

Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

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http://clincancerres.aacrjournals.org/content/early/2016/10/
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http://dx.doi.org/10.1158/1078-0432.CCR-16-1010DOI Listing
November 2016

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

Clin Cancer Res 2016 06;22(11):2613-7

U.S. Food and Drug Administration, Silver Spring, Maryland.

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http://dx.doi.org/10.1158/1078-0432.CCR-15-2643DOI Listing
June 2016

Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials: Symptomatic Adverse Events, Physical Function, and Disease-Related Symptoms.

Clin Cancer Res 2016 Apr 12;22(7):1553-8. Epub 2016 Jan 12.

Office of Hematology and Oncology Products, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

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http://dx.doi.org/10.1158/1078-0432.CCR-15-2035DOI Listing
April 2016

Benefit-Risk Summary of Nivolumab for Patients With Metastatic Squamous Cell Lung Cancer After Platinum-Based Chemotherapy: A Report From the US Food and Drug Administration.

JAMA Oncol 2016 Jan;2(1):118-22

Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.

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http://dx.doi.org/10.1001/jamaoncol.2015.3934DOI Listing
January 2016

U.S. Food and Drug Administration Approval Summary: Enzalutamide for the Treatment of Patients With Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer.

Oncologist 2015 Aug 12;20(8):960-6. Epub 2015 Jun 12.

Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.

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http://dx.doi.org/10.1634/theoncologist.2015-0166DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4524760PMC
August 2015

Development of Systemic and Topical Drugs to Treat Non-muscle Invasive Bladder Cancer.

Bladder Cancer 2015;1(2):133-136. Epub 2015 Oct 26.

Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, FDA, MD, USA.

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http://dx.doi.org/10.3233/BLC-150016DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4832566PMC
October 2015

Reply to Letter to the Editor: Local Evaluation and Blinded Central Review Comparison a Victim of Meta-analysis Shortcomings.

Ther Innov Regul Sci 2014 Mar;48(2):NP1-NP2

2 Division of Biometrics V, Office of Biostatistics, Office of Translational Science, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

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http://dx.doi.org/10.1177/2168479014520698DOI Listing
March 2014

Radium Ra 223 dichloride injection: U.S. Food and Drug Administration drug approval summary.

Clin Cancer Res 2014 Jan 4;20(1):9-14. Epub 2013 Nov 4.

Authors' Affiliations: Office of Hematology and Oncology Products, Office of Biostatistics, Office of Clinical Pharmacology, and Office of Pharmaceutical Science, Office of New Drug Quality Assessment, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

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http://dx.doi.org/10.1158/1078-0432.CCR-13-2665DOI Listing
January 2014

Abiraterone acetate in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer: U.S. Food and Drug Administration drug approval summary.

Clin Cancer Res 2013 Dec 22;19(24):6650-6. Epub 2013 Oct 22.

Authors' Affiliations: Office of Hematology and Oncology Products, Office of New Drugs, Office of Biostatistics, Office of Clinical Pharmacology, and Office of New Drug Quality Assessment, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

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http://dx.doi.org/10.1158/1078-0432.CCR-13-2134DOI Listing
December 2013

Enzalutamide for treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel: U.S. Food and Drug Administration drug approval summary.

Clin Cancer Res 2013 Nov 18;19(22):6067-73. Epub 2013 Oct 18.

Authors' Affiliations: Office of Hematology and Oncology Products, Office of New Drugs, Office of Biostatistics, Office of Clinical Pharmacology, Office of New Drug Quality Assessment, and Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

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http://dx.doi.org/10.1158/1078-0432.CCR-13-1763DOI Listing
November 2013

U.s. Food and Drug Administration approval: carfilzomib for the treatment of multiple myeloma.

Clin Cancer Res 2013 Sep 17;19(17):4559-63. Epub 2013 Jun 17.

Office of Hematology and Oncology Drug Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland 20993, USA.

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http://dx.doi.org/10.1158/1078-0432.CCR-13-0755DOI Listing
September 2013

Missing data and measurement variability in assessing progression-free survival endpoint in randomized clinical trials.

Clin Cancer Res 2013 May;19(10):2613-20

CDER/OTS/OB/DBV, U.S. Food and Drug Administration, Silver Spring, Maryland 20993, USA.

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http://dx.doi.org/10.1158/1078-0432.CCR-12-2938DOI Listing
May 2013

Assessment of audit methodologies for bias evaluation of tumor progression in oncology clinical trials.

Clin Cancer Res 2013 May 26;19(10):2637-45. Epub 2013 Mar 26.

Division of Biometrics V/Office of Biostatistics/Office of Translational Sciences, Center for Drug Evaluation Research, U.S. Food and Drug Administration, Silver Spring, Maryland 20993, USA.

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http://clincancerres.aacrjournals.org/content/early/2013/03/
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http://clincancerres.aacrjournals.org/content/19/10/2637.ful
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http://clincancerres.aacrjournals.org/cgi/doi/10.1158/1078-0
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http://dx.doi.org/10.1158/1078-0432.CCR-12-3364DOI Listing
May 2013

Evaluation of Blinded Independent Central Review of Tumor Progression in Oncology Clinical Trials: A Meta-analysis.

Ther Innov Regul Sci 2013 Mar;47(2):167-174

1 Division of Biometrics V, Office of Biostatistics, Office of Translational Sciences, Center of Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

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http://dx.doi.org/10.1177/0092861512459733DOI Listing
March 2013

Relationship Between Progression-Free Survival and Overall Survival Benefit: A Simulation Study.

Ther Innov Regul Sci 2013 Jan;47(1):95-100

1 Division of Biometrics V, Office of Biostatistics, Office of Translational Sciences, Center of Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

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http://dx.doi.org/10.1177/0092861512459180DOI Listing
January 2013

FDA approval summary: sunitinib for the treatment of progressive well-differentiated locally advanced or metastatic pancreatic neuroendocrine tumors.

Oncologist 2012 26;17(8):1108-13. Epub 2012 Jul 26.

Food and Drug Administration, White Oak Campus, 10903 New Hampshire Avenue, Building 22, Room 1243, Silver Spring, Maryland 20993-0002, USA.

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http://dx.doi.org/10.1634/theoncologist.2012-0044DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3425529PMC
April 2013

Overestimation of the effect size in group sequential trials.

Clin Cancer Res 2012 Sep 2;18(18):4872-6. Epub 2012 Jul 2.

CDER/OTS/OB/DBV, and CDER/OND/OHOP/DOP-1, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA.

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http://dx.doi.org/10.1158/1078-0432.CCR-11-3118DOI Listing
September 2012

U.S. Food and Drug Administration approval: ruxolitinib for the treatment of patients with intermediate and high-risk myelofibrosis.

Clin Cancer Res 2012 Jun 27;18(12):3212-7. Epub 2012 Apr 27.

Office of Hematology and Oncology Drug Products, Study Endpoints and Label Development, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993, USA.

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http://dx.doi.org/10.1158/1078-0432.CCR-12-0653DOI Listing
June 2012

US Food and Drug Administration approval overview in metastatic breast cancer.

J Clin Oncol 2012 May 19;30(14):1705-11. Epub 2012 Mar 19.

US Food and Drug Administration, Silver Spring, MD 20993-0002, USA.

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http://dx.doi.org/10.1200/JCO.2011.39.2613DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3383116PMC
May 2012

Approval summary: erlotinib maintenance therapy of advanced/metastatic non-small cell lung cancer (NSCLC).

Oncologist 2010 10;15(12):1344-51. Epub 2010 Dec 10.

Office of Oncology Drug Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland 20993-0002, USA.

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http://dx.doi.org/10.1634/theoncologist.2010-0257DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3227916PMC
April 2011

FDA approval summary: temsirolimus as treatment for advanced renal cell carcinoma.

Oncologist 2010 23;15(4):428-35. Epub 2010 Mar 23.

Division of Drug Oncology Products, Office of Oncology Drug Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland 20993-0002, USA.

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http://dx.doi.org/10.1634/theoncologist.2009-0178DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3227966PMC
September 2010

Review of oncology and hematology drug product approvals at the US Food and Drug Administration between July 2005 and December 2007.

J Natl Cancer Inst 2010 Feb 29;102(4):230-43. Epub 2010 Jan 29.

Division of Biometrics V, Office of Translational Sciences, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, USA.

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https://academic.oup.com/jnci/article-lookup/doi/10.1093/jnc
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http://dx.doi.org/10.1093/jnci/djp515DOI Listing
February 2010

Sorafenib for the treatment of unresectable hepatocellular carcinoma.

Oncologist 2009 Jan 14;14(1):95-100. Epub 2009 Jan 14.

Office of Oncology Drug Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993-0004, USA.

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http://dx.doi.org/10.1634/theoncologist.2008-0185DOI Listing
January 2009

Lenalidomide in combination with dexamethasone for the treatment of multiple myeloma after one prior therapy.

Oncologist 2008 Oct 15;13(10):1120-7. Epub 2008 Oct 15.

Office of Oncology Drug Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993-0002, USA.

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http://dx.doi.org/10.1634/theoncologist.2008-0077DOI Listing
October 2008

FDA drug approval summary: lapatinib in combination with capecitabine for previously treated metastatic breast cancer that overexpresses HER-2.

Oncologist 2008 Oct 10;13(10):1114-9. Epub 2008 Oct 10.

Division of Oncology Drug Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993, USA.

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http://dx.doi.org/10.1634/theoncologist.2008-0816DOI Listing
October 2008

Tasigna for chronic and accelerated phase Philadelphia chromosome--positive chronic myelogenous leukemia resistant to or intolerant of imatinib.

Clin Cancer Res 2008 Sep;14(17):5325-31

Office of Oncology Drug Products, Office of New Drugs, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland 20993, USA.

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http://dx.doi.org/10.1158/1078-0432.CCR-08-0308DOI Listing
September 2008

Use of progression-free survival as a surrogate marker in oncology trials: some regulatory issues.

Stat Methods Med Res 2008 Oct 19;17(5):515-8. Epub 2008 Feb 19.

Office of Biostatistics, Center for Drug Evaluation and Research, FDA, MD, USA.

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http://dx.doi.org/10.1177/0962280207081862DOI Listing
October 2008

Erlotinib/gemcitabine for first-line treatment of locally advanced or metastatic adenocarcinoma of the pancreas.

Oncology (Williston Park) 2007 Dec;21(14):1696-706; discussion 1706-9, 1712, 1715

Office of Oncology Drug Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993, USA.

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December 2007