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U.S. Department of Health and Human Services

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Publications OHOP 2005-206

2006

Dagher RN and Pazdur R. Role of FDA in the Regulation of Anti-Cancer Drugs. Current Cancer Therapy Reviews 2(4):327-329, 2006

Brave M, Dagher R, Farrell A et al. FDA Approval Summary : Topotecan in Combination with Cisplatin for the Treatment of Stage IVB, Recurrent or Persistent Cervical Cancer. Oncology 20(11):1401-1410, 2006.

Kane R,  Farrell A, Sridhara R, Pazdur R. United States Food and Drug Administration approval summary: bortezomib for the treatment of progressive multiple myeloma after one prior therapy. Clin Cancer Res. 2006 May 15;12(10): 2966-2950 [HTML] [PDF]

Rahman A, White RM. Cytotoxic anticancer agents and renal impairment study: the challenge remains (Editorial). J Clin Oncol. 2006 Feb 1;24(4):533-6. [PubMed]

Rahman NA, White RM. Design, conduct, and interpretation of organ impairment studies in oncology patients (In reply). J Clin Oncol. 2006;24:3510-3511

Suleiman OH, Fejka R, Houn F, Walsh M. The Radioactive Drug Research Committee: Background and Retrospective Study of Reported Research Data (1975-2004). J Nucl Med 2006 Jul;47(7):1220-6.

2005

Aguero MF, Facchinetti MM, Sheleg Z, Senderowicz AM. Phenoxodiol, a novel isoflavone, induces G1 arrest by specific loss in cyclin-dependent kinase 2 activity by p53-independent induction of p21WAF1/CIP1. Cancer Res. 2005 Apr 15;65(8):3364-73.

Anderson KC, Pazdur R, Farrell AT. Development of effective new treatments for multiple myeloma. J Clin Oncol. 2005 Oct 1;23(28):7207-11.

Bilenker JH, Flaherty KT, Rosen M, Davis L, Gallagher M, Stevenson JP, Sun W, Vaughn D, Giantonio B, Zimmer R, Schnall M, O'Dwyer PJ.  Phase I trial of combretastatin a-4 phosphate with carboplatin. Clin Cancer Res. 2005 Feb 15;11(4):1527-33.

Bilenker JH, Haller DG. Future directions with angiogenesis inhibitors in colorectal cancer. Clin Colorectal Cancer. 2004 Oct;4 Suppl 2:S86-93.

Brinker A, He R, Desai M, Gelperin K, Robie-Suh K. Safety of ximelagatran. JAMA. 2005 Jun 15; 293(23):2859

Cohen MH, Johnson JR, Chen YF, Sridhara R, Pazdur R. FDA drug approval summary: erlotinib (Tarceva) tablets. Oncologist. 2005 Aug;10(7):461-6.

Cohen MH, Johnson JR, Pazdur R. Food and Drug Administration Drug approval summary: temozolomide plus radiation therapy for the treatment of newly diagnosed glioblastoma multiforme. Clin Cancer Res. 2005 Oct 1;11(19 Pt 1):6767-71.

Cohen MH, Johnson JR, Wang YC, Sridhara R, Pazdur R. FDA drug approval summary: pemetrexed for injection (Alimta) for the treatment of non-small cell lung cancer. Oncologist. 2005 Jun-Jul;10(6):363-8.

Farrell AT, Papadouli, I, Hori, A, Harczy, M, B. Harrison, B,  Asakura, W, Marty, M, Dagher, R,  Pazdur, R. The advisory process for anticancer drug regulation: a global perspective. Ann  Oncol. 2005 Dec 15; [PubMed]

 Gray JE, Archer BR, Butler PF, Hobbs BB, Mettler FA Jr, Pizzutiello RJ Jr, Schueler BA, Strauss KJ, Suleiman OH, Yaffe MJ.  Reference values for diagnostic radiology: application and impact. Radiology. 2005 May;235(2):354-8.

Hazarika M, White RM Jr, Booth BP, Wang YC, Ham DY, Liang CY, Rahman A, Gobburu JV, Li N, Sridhara R, Morse DE, Lostritto R, Garvey P, Johnson JR, Pazdur R. Pemetrexed in malignant pleural mesothelioma. Clin Cancer Res. 2005 Feb 1;11(3):982-92.

Johnson JR, Cohen M, Sridhara R, Chen YF, Williams GM, Duan J, Gobburu J, Booth B, Benson K, Leighton J, Hsieh LS, Chidambaram N, Zimmerman P, Pazdur R.  Approval summary for erlotinib for treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen. Clin Cancer Res. 2005 Sep 15;11(18):6414-21.

Kane RC, Farrell AT, Saber H, Tang S, Williams G, Jee JM, Liang C, Booth B, Chidambaram N, Morse D, Sridhara R, Garvey P, Justice R, and Pazdur R. Sorafenib for the Treatment of Advanced Renal Cell Carcinoma Clin. Cancer Res. 2006 12: 7271-7278. [Abstract]

Kaminskas E, Farrell A, Abraham S, Baird A, Hsieh LS, Lee SL, Leighton JK, Patel H, Rahman A, Sridhara R, Wang YC, Pazdur R. FDA Approval summary: azacitidine for treatment of myelodysplastic syndrome subtypes. Clin Cancer Res. 2005 May 15;11(10):3604-8.

Kaminskas E, Farrell AT, Wang YC, Sridhara R, Pazdur R. FDA drug approval summary: azacitidine (5-azacytidine, Vidaza) for injectable suspension. Oncologist. 2005 Mar;10(3):176-82. Leighton JK.  Application of emerging technologies in toxicology and safety assessment: regulatory perspectives. Int J Toxicol. 2005 May-Jun;24(3):153-5.

Mahmood I, Green MD.  Pharmacokinetic and pharmacodynamic considerations in the development of therapeutic proteins. Clin Pharmacokinet. 2005;44(4):331-47.

Mann BS, Johnson JR, Kelly R, Sridhara R, Williams G, Pazdur R.  Letrozole in the extended adjuvant treatment of postmenopausal women with history of early-stage breast cancer who have completed 5 years of adjuvant tamoxifen. Clin Cancer Res. 2005 Aug 15;11(16):5671-7.

Kelloff GJ, Krohn KA, Larson SM, Weissleder R, Mankoff DA, Hoffman JM, Link JM, Guyton KZ, Eckelman WC, Scher HI, O'Shaughnessy J, Cheson BD, Sigman CC, Tatum JL, Mills GQ, Sullivan DC, Woodcock J.  The progress and promise of molecular imaging probes in oncologic drug development. Clin Cancer Res. 2005 Nov 15;11(22):7967-85.

Mukhopadhyay UK, Senderowicz AM, Ferbeyre G. RNA silencing of checkpoint regulators sensitizes p53-defective prostate cancer cells to chemotherapy while sparing normal cells. Cancer Res. 2005 Apr 1;65(7):2872-81.

Pazdur R. The FDA's new oncology office. Clin Adv Hematol Oncol. 2005 Aug;3(8):612-3.

Senderowicz AM. Inhibitors of cyclin-dependent kinase modulators for cancer therapy. Prog Drug Res. 2005;63:183-206.

Weinberg WC, Frazier-Jessen MR, Wu WJ, Weir A, Hartsough M, Keegan P, Fuchs C. Development and regulation of monoclonal antibody products: challenges and opportunities. Cancer Metastasis Rev. 2005; Dec;24(4):569-84.