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Items: 1 to 50 of 117

1.

Determination of Similarity Margin in Comparative Clinical Studies to Support the Development of Biosimilar Products of Neupogen® (Filgrastim, Granulocyte Colony-Stimulating Factor [G-CSF]).

Nie L, Przepiorka D, Deisseroth A, Sridhara R, Gwise TE.

BioDrugs. 2018 Jul 13. doi: 10.1007/s40259-018-0288-z. [Epub ahead of print]

PMID:
30006915
2.

Informing the Tolerability of Cancer Treatments Using Patient-Reported Outcome Measures: Summary of an FDA and Critical Path Institute Workshop.

Kluetz PG, Kanapuru B, Lemery S, Johnson LL, Fiero MH, Arscott K, Barbachano Y, Basch E, Campbell M, Cappelleri JC, Cella D, Cleeland C, Coens C, Daniels S, Denlinger CS, Fairclough DL, Hillard JR, Minasian L, Mitchell SA, O'Connor D, Patel S, Rubin EH, Ryden A, Soltys K, Sridhara R, Thanarajasingam G, Velikova G, Coons SJ.

Value Health. 2018 Jun;21(6):742-747. doi: 10.1016/j.jval.2017.09.009. Epub 2017 Nov 7.

PMID:
29909880
3.

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

Jin S, Mishra-Kalyani PS, Sridhara R.

Ther Innov Regul Sci. 2018 Jan 1:2168479018769286. doi: 10.1177/2168479018769286. [Epub ahead of print]

PMID:
29714599
4.

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 Apr 12. doi: 10.1158/1078-0432.CCR-18-0042. [Epub ahead of print]

PMID:
29650751
5.

Clonidine as an Adjuvant to Caudal Epidural Ropivacaine for Lumbosacral Spine Surgeries.

Nagappa S, Kalappa S, Sridhara RB.

Anesth Essays Res. 2018 Jan-Mar;12(1):240-245. doi: 10.4103/aer.AER_215_17.

6.

Evaluation of the Hemodynamic Response of Intravenous Clonidine versus Ropivacaine Scalp Block to Insertion of Scalp Pins in Neurosurgical Patients.

Nagappa S, Kalappa S, Sridhara RB.

Anesth Essays Res. 2018 Jan-Mar;12(1):213-217. doi: 10.4103/0259-1162.194572.

7.

Exploratory analysis of the association of depth of response and survival in patients with metastatic non-small-cell lung cancer treated with a targeted therapy or immunotherapy.

McCoach CE, Blumenthal GM, Zhang L, Myers A, Tang S, Sridhara R, Keegan P, Pazdur R, Doebele RC, Kazandjian D.

Ann Oncol. 2018 Feb 26. doi: 10.1093/annonc/mdy045. [Epub ahead of print] No abstract available.

PMID:
29529128
8.

U.S. Food and Drug Administration Approval: Neratinib for the Extended Adjuvant Treatment of Early Stage HER2-Positive Breast Cancer.

Singh H, Walker AJ, Amiri-Kordestani L, Cheng J, Tang S, Balcazar P, Barnett-Ringgold K, Palmby TR, Cao X, Zheng N, Liu Q, Yu J, Pierce WF, Daniels SR, Sridhara R, Ibrahim A, Kluetz PG, Blumenthal GM, Beaver JA, Pazdur R.

Clin Cancer Res. 2018 Mar 9. pii: clincanres.3628.2017. doi: 10.1158/1078-0432.CCR-17-3628. [Epub ahead of print]

PMID:
29523624
9.

US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments.

Wedam SB, Beaver JA, Amiri-Kordestani L, Bloomquist E, Tang S, Goldberg KB, Sridhara R, Ibrahim A, Kim G, Kluetz P, McKee A, Pazdur R.

J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9.

PMID:
29522361
10.

A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics: A Review.

Beaver JA, Howie LJ, Pelosof L, Kim T, Liu J, Goldberg KB, Sridhara R, Blumenthal GM, Farrell AT, Keegan P, Pazdur R, Kluetz PG.

JAMA Oncol. 2018 Jun 1;4(6):849-856. doi: 10.1001/jamaoncol.2017.5618.

PMID:
29494733
11.

FDA Approval: Ribociclib for the Treatment of Postmenopausal Women with Hormone Receptor-Positive, HER2-Negative Advanced or Metastatic Breast Cancer.

Shah A, Bloomquist E, Tang S, Fu W, Bi Y, Liu Q, Yu J, Zhao P, Palmby TR, Goldberg KB, Chang CJG, Patel P, Alebachew E, Tilley A, Pierce WF, Ibrahim A, Blumenthal GM, Sridhara R, Beaver JA, Pazdur R.

Clin Cancer Res. 2018 Jul 1;24(13):2999-3004. doi: 10.1158/1078-0432.CCR-17-2369. Epub 2018 Feb 7.

PMID:
29437768
12.

Patients with melanoma treated with an anti-PD-1 antibody beyond RECIST progression: a US Food and Drug Administration pooled analysis.

Beaver JA, Hazarika M, Mulkey F, Mushti S, Chen H, He K, Sridhara R, Goldberg KB, Chuk MK, Chi DC, Chang J, Barone A, Balasubramaniam S, Blumenthal GM, Keegan P, Pazdur R, Theoret MR.

Lancet Oncol. 2018 Feb;19(2):229-239. doi: 10.1016/S1470-2045(17)30846-X. Epub 2018 Jan 18.

PMID:
29361469
13.

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

Mushti SL, Mulkey F, Sridhara R.

Clin Cancer Res. 2018 May 15;24(10):2268-2275. doi: 10.1158/1078-0432.CCR-17-1902. Epub 2018 Jan 11.

PMID:
29326281
14.

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

Gao X, Zhang L, Sridhara R.

Clin Cancer Res. 2018 May 15;24(10):2262-2267. doi: 10.1158/1078-0432.CCR-17-2111. Epub 2017 Dec 26.

PMID:
29279318
15.

Use of PRO Measures to Inform Tolerability in Oncology Trials: Implications for Clinical Review, IND Safety Reporting, and Clinical Site Inspections.

Kim J, Singh H, Ayalew K, Borror K, Campbell M, Johnson LL, Karesh A, Khin NA, Less JR, Menikoff J, Minasian L, Mitchell SA, Papadopoulos EJ, Piekarz RL, Prohaska KA, Thompson S, Sridhara R, Pazdur R, Kluetz PG.

Clin Cancer Res. 2018 Apr 15;24(8):1780-1784. doi: 10.1158/1078-0432.CCR-17-2555. Epub 2017 Dec 13.

PMID:
29237718
16.

Exploratory analysis of the association of depth of response and survival in patients with metastatic non-small-cell lung cancer treated with a targeted therapy or immunotherapy.

McCoach CE, Blumenthal GM, Zhang L, Myers A, Tang S, Sridhara R, Keegan P, Pazdur R, Doebele RC, Kazandjian D.

Ann Oncol. 2017 Nov 1;28(11):2707-2714. doi: 10.1093/annonc/mdx414.

PMID:
29045514
17.

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

Kim ES, Bruinooge SS, Roberts S, Ison G, Lin NU, Gore L, Uldrick TS, Lichtman SM, Roach N, Beaver JA, Sridhara R, Hesketh PJ, Denicoff AM, Garrett-Mayer E, Rubin E, Multani P, Prowell TM, Schenkel C, Kozak M, Allen J, Sigal E, Schilsky RL.

J Clin Oncol. 2017 Nov 20;35(33):3737-3744. doi: 10.1200/JCO.2017.73.7916. Epub 2017 Oct 2.

PMID:
28968170
18.

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

Jin S, Pazdur R, Sridhara R.

J Clin Oncol. 2017 Nov 20;35(33):3745-3752. doi: 10.1200/JCO.2017.73.4186. Epub 2017 Oct 2.

PMID:
28968168
19.

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.

20.

FDA Approval Summary: Rucaparib for the Treatment of Patients with Deleterious BRCA Mutation-Associated Advanced Ovarian Cancer.

Balasubramaniam S, Beaver JA, Horton S, Fernandes LL, Tang S, Horne HN, Liu J, Liu C, Schrieber SJ, Yu J, Song P, Pierce W, Robertson KJ, Palmby TR, Chiu HJ, Lee EY, Philip R, Schuck R, Charlab R, Banerjee A, Chen XH, Wang X, Goldberg KB, Sridhara R, Kim G, Pazdur R.

Clin Cancer Res. 2017 Dec 1;23(23):7165-7170. doi: 10.1158/1078-0432.CCR-17-1337. Epub 2017 Jul 27.

PMID:
28751443
21.

Milestone Analyses of Immune Checkpoint Inhibitors, Targeted Therapy, and Conventional Therapy in Metastatic Non-Small Cell Lung Cancer Trials: A Meta-analysis.

Blumenthal GM, Zhang L, Zhang H, Kazandjian D, Khozin S, Tang S, Goldberg K, Sridhara R, Keegan P, Pazdur R.

JAMA Oncol. 2017 Aug 10;3(8):e171029. doi: 10.1001/jamaoncol.2017.1029. Epub 2017 Aug 10.

22.

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.

23.

FDA Approval Summary: Nivolumab in Advanced Renal Cell Carcinoma After Anti-Angiogenic Therapy and Exploratory Predictive Biomarker Analysis.

Xu JX, Maher VE, Zhang L, Tang S, Sridhara R, Ibrahim A, Kim G, Pazdur R.

Oncologist. 2017 Mar;22(3):311-317. doi: 10.1634/theoncologist.2016-0476. Epub 2017 Feb 23.

24.

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
25.

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

Kluetz PG, Papadopoulos EJ, Johnson LL, Donoghue M, Kwitkowski VE, Chen WH, Sridhara R, Farrell AT, Keegan P, Kim G, Pazdur R.

Clin Cancer Res. 2016 Nov 15;22(22):5618. doi: 10.1158/1078-0432.CCR-16-2140. No abstract available.

26.

U.S. FDA Approval Summary: Nivolumab for Treatment of Unresectable or Metastatic Melanoma Following Progression on Ipilimumab.

Hazarika M, Chuk MK, Theoret MR, Mushti S, He K, Weis SL, Putman AH, Helms WS, Cao X, Li H, Zhao H, Zhao L, Welch J, Graham L, Libeg M, Sridhara R, Keegan P, Pazdur R.

Clin Cancer Res. 2017 Jul 15;23(14):3484-3488. doi: 10.1158/1078-0432.CCR-16-0712. Epub 2017 Jan 13.

27.

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.

28.

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

He K, Chen H, Gwise T, Casak S, Lemery S, Keegan P, Pazdur R, Sridhara R.

Clin Cancer Res. 2016 Nov 1;22(21):5167-5170. Epub 2016 Aug 31.

29.

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.

30.

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.

31.

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.

32.

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.

33.

Dexmedetomidine as an Adjuvant to Pre-Emptive Caudal Epidural Ropivacaine for Lumbosacral Spine Surgeries.

Kalappa S, Sridhara RB, Kumaraswamy S.

J Clin Diagn Res. 2016 Jan;10(1):UC22-4. doi: 10.7860/JCDR/2016/15286.7145. Epub 2016 Jan 1.

34.

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

Kluetz PG, Slagle A, Papadopoulos EJ, Johnson LL, Donoghue M, Kwitkowski VE, Chen WH, Sridhara R, Farrell AT, Keegan P, Kim G, Pazdur R.

Clin Cancer Res. 2016 Apr 1;22(7):1553-8. doi: 10.1158/1078-0432.CCR-15-2035. Epub 2016 Jan 12.

35.

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.

Kazandjian D, Khozin S, Blumenthal G, Zhang L, Tang S, Libeg M, Kluetz P, Sridhara R, Keegan P, Pazdur R.

JAMA Oncol. 2016 Jan;2(1):118-22. doi: 10.1001/jamaoncol.2015.3934.

PMID:
26470053
36.

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.

37.

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.

38.

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

Ning YM, Brave M, Maher VE, Zhang L, Tang S, Sridhara R, Kim G, Ibrahim A, Pazdur R.

Oncologist. 2015 Aug;20(8):960-6. doi: 10.1634/theoncologist.2015-0166. Epub 2015 Jun 12.

39.

Overall response rate, progression-free survival, and overall survival with targeted and standard therapies in advanced non-small-cell lung cancer: US Food and Drug Administration trial-level and patient-level analyses.

Blumenthal GM, Karuri SW, Zhang H, Zhang L, Khozin S, Kazandjian D, Tang S, Sridhara R, Keegan P, Pazdur R.

J Clin Oncol. 2015 Mar 20;33(9):1008-14. doi: 10.1200/JCO.2014.59.0489. Epub 2015 Feb 9.

40.

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

Jarow J, Maher VE, Tang S, Ibrahim A, Kim G, Sridhara R, Pazdur R.

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

41.

Cyclic stretch-induced TGF-β1 and fibronectin expression is mediated by β1-integrin through c-Src- and STAT3-dependent pathways in renal epithelial cells.

Hamzeh MT, Sridhara R, Alexander LD.

Am J Physiol Renal Physiol. 2015 Mar 1;308(5):F425-36. doi: 10.1152/ajprenal.00589.2014. Epub 2014 Dec 4.

42.

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.

43.

Reply by the authors.

Jarow J, Kluetz PG, Lerner SP, Liu K, Sridhara R, Bajorin D, Chang S, Dinney CP, Groshen S, Morton RA, O'Donnell M, Quale DZ, Schoenberg M, Seigne J, Vikram B.

Urology. 2014 Aug;84(2):495-6. doi: 10.1016/j.urology.2014.04.004. No abstract available.

PMID:
25065996
44.

FDA approval: ado-trastuzumab emtansine for the treatment of patients with HER2-positive metastatic breast cancer.

Amiri-Kordestani L, Blumenthal GM, Xu QC, Zhang L, Tang SW, Ha L, Weinberg WC, Chi B, Candau-Chacon R, Hughes P, Russell AM, Miksinski SP, Chen XH, McGuinn WD, Palmby T, Schrieber SJ, Liu Q, Wang J, Song P, Mehrotra N, Skarupa L, Clouse K, Al-Hakim A, Sridhara R, Ibrahim A, Justice R, Pazdur R, Cortazar P.

Clin Cancer Res. 2014 Sep 1;20(17):4436-41. doi: 10.1158/1078-0432.CCR-14-0012. Epub 2014 May 30.

45.

Drug and device development for localized prostate cancer: report of a Food and Drug Administration/American Urological Association public workshop.

Jarow JP, Thompson IM, Kluetz PG, Baxley J, Sridhara R, Scardino P, Carroll P, Albertsen P, Carter HB, Brawley O, Sartor O, Sandler H, Kiefert JJ, Morton RA Jr.

Urology. 2014 May;83(5):975-8. doi: 10.1016/j.urology.2013.10.087. Epub 2014 Mar 22.

PMID:
24661332
46.

Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis.

Cortazar P, Zhang L, Untch M, Mehta K, Costantino JP, Wolmark N, Bonnefoi H, Cameron D, Gianni L, Valagussa P, Swain SM, Prowell T, Loibl S, Wickerham DL, Bogaerts J, Baselga J, Perou C, Blumenthal G, Blohmer J, Mamounas EP, Bergh J, Semiglazov V, Justice R, Eidtmann H, Paik S, Piccart M, Sridhara R, Fasching PA, Slaets L, Tang S, Gerber B, Geyer CE Jr, Pazdur R, Ditsch N, Rastogi P, Eiermann W, von Minckwitz G.

Lancet. 2014 Jul 12;384(9938):164-72. doi: 10.1016/S0140-6736(13)62422-8. Epub 2014 Feb 14. Review.

PMID:
24529560
47.

Clinical trial design for the development of new therapies for nonmuscle-invasive bladder cancer: report of a Food and Drug Administration and American Urological Association public workshop.

Jarow JP, Lerner SP, Kluetz PG, Liu K, Sridhara R, Bajorin D, Chang S, Dinney CP, Groshen S, Morton RA, O'Donnell M, Quale DZ, Schoenberg M, Seigne J, Vikram B.

Urology. 2014 Feb;83(2):262-4. doi: 10.1016/j.urology.2013.10.030. Epub 2013 Dec 12.

PMID:
24332121
48.

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

Kluetz PG, Pierce W, Maher VE, Zhang H, Tang S, Song P, Liu Q, Haber MT, Leutzinger EE, Al-Hakim A, Chen W, Palmby T, Alebachew E, Sridhara R, Ibrahim A, Justice R, Pazdur R.

Clin Cancer Res. 2014 Jan 1;20(1):9-14. doi: 10.1158/1078-0432.CCR-13-2665. Epub 2013 Nov 4.

49.

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.

50.

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.

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