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Items: 8

1.

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.

2.

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

Barone A, Hazarika M, Theoret MR, Mishra-Kalyani P, Chen H, He K, Sridhara R, Subramaniam S, Pfuma E, Wang Y, Li H, Zhao H, Zirkelbach JF, Keegan P, Pazdur R.

Clin Cancer Res. 2017 Oct 1;23(19):5661-5665. doi: 10.1158/1078-0432.CCR-16-0664. Epub 2017 Feb 8.

PMID:
28179454
3.

FDA Approval: Palbociclib for the Treatment of Postmenopausal Patients with Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer.

Beaver JA, Amiri-Kordestani L, Charlab R, Chen W, Palmby T, Tilley A, Zirkelbach JF, Yu J, Liu Q, Zhao L, Crich J, Chen XH, Hughes M, Bloomquist E, Tang S, Sridhara R, Kluetz PG, Kim G, Ibrahim A, Pazdur R, Cortazar P.

Clin Cancer Res. 2015 Nov 1;21(21):4760-6. doi: 10.1158/1078-0432.CCR-15-1185. Epub 2015 Aug 31. Review.

4.

FDA approval: siltuximab for the treatment of patients with multicentric Castleman disease.

Deisseroth A, Ko CW, Nie L, Zirkelbach JF, Zhao L, Bullock J, Mehrotra N, Del Valle P, Saber H, Sheth C, Gehrke B, Justice R, Farrell A, Pazdur R.

Clin Cancer Res. 2015 Mar 1;21(5):950-4. doi: 10.1158/1078-0432.CCR-14-1678. Epub 2015 Jan 19. Review.

5.

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.

6.

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.

Kluetz PG, Ning YM, Maher VE, Zhang L, Tang S, Ghosh D, Aziz R, Palmby T, Pfuma E, Zirkelbach JF, Mehrotra N, Tilley A, Sridhara R, Ibrahim A, Justice R, Pazdur R.

Clin Cancer Res. 2013 Dec 15;19(24):6650-6. doi: 10.1158/1078-0432.CCR-13-2134. Epub 2013 Oct 22.

7.

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.

Ning YM, Pierce W, Maher VE, Karuri S, Tang SH, Chiu HJ, Palmby T, Zirkelbach JF, Marathe D, Mehrotra N, Liu Q, Ghosh D, Cottrell CL, Leighton J, Sridhara R, Ibrahim A, Justice R, Pazdur R.

Clin Cancer Res. 2013 Nov 15;19(22):6067-73. doi: 10.1158/1078-0432.CCR-13-1763. Epub 2013 Oct 18.

8.

Bioequivalence of long half-life drugs--informative sampling determination--using truncated area in parallel-designed studies for slow sustained-release formulations.

El-Tahtawy A, Harrison F, Zirkelbach JF, Jackson AJ.

J Pharm Sci. 2012 Nov;101(11):4337-46. doi: 10.1002/jps.23296. Epub 2012 Aug 24.

PMID:
22927120

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