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US Food and Drug Administration Approval Summary: Elacestrant for Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative, ESR1-Mutated Advanced or Metastatic Breast Cancer.
Shah M, Lingam H, Gao X, Gittleman H, Fiero MH, Krol D, Biel N, Ricks TK, Fu W, Hamed S, Li F, Sun JJ, Fan J, Schuck R, Grimstein M, Tang L, Kalavar S, Abukhdeir A, Pathak A, Ghosh S, Bulatao I, Tilley A, Pierce WF, Mixter BD, Tang S, Pazdur R, Kluetz P, Amiri-Kordestani L. Shah M, et al. Among authors: kluetz p. J Clin Oncol. 2024 Apr 1;42(10):1193-1201. doi: 10.1200/JCO.23.02112. Epub 2024 Feb 21. J Clin Oncol. 2024. PMID: 38381994 Clinical Trial.
Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI): stakeholder views, objectives, and procedures.
Pe M, Alanya A, Falk RS, Amdal CD, Bjordal K, Chang J, Cislo P, Coens C, Dirven L, Speck RM, Fitzgerald K, Galinsky J, Giesinger JM, Holzner B, Le Cessie S, O'Connor D, Oliver K, Pawar V, Quinten C, Schlichting M, Ren J, Roychoudhury S, Taphoorn MJB, Velikova G, Wintner LM, Griebsch I, Bottomley A; SISAQOL-IMI Consortium. Pe M, et al. Lancet Oncol. 2023 Jun;24(6):e270-e283. doi: 10.1016/S1470-2045(23)00157-2. Lancet Oncol. 2023. PMID: 37269858 Free article. Review.
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. Kluetz PG, et al. Clin Cancer Res. 2013 Dec 15;19(24):6650-6. doi: 10.1158/1078-0432.CCR-13-2134. Epub 2013 Oct 22. Clin Cancer Res. 2013. PMID: 24150234 Clinical Trial.
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. Kluetz PG, et al. Clin Cancer Res. 2014 Jan 1;20(1):9-14. doi: 10.1158/1078-0432.CCR-13-2665. Epub 2013 Nov 4. Clin Cancer Res. 2014. PMID: 24190979 Clinical Trial.
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. Beaver JA, et al. Among authors: kluetz pg. Clin Cancer Res. 2015 Nov 1;21(21):4760-6. doi: 10.1158/1078-0432.CCR-15-1185. Epub 2015 Aug 31. Clin Cancer Res. 2015. PMID: 26324739 Review.
U.S. Food and Drug Administration Approval Summary: Ramucirumab for the Treatment of Metastatic Non-Small Cell Lung Cancer Following Disease Progression On or After Platinum-Based Chemotherapy.
Larkins E, Scepura B, Blumenthal GM, Bloomquist E, Tang S, Biable M, Kluetz P, Keegan P, Pazdur R. Larkins E, et al. Among authors: kluetz p. Oncologist. 2015 Nov;20(11):1320-5. doi: 10.1634/theoncologist.2015-0221. Epub 2015 Oct 7. Oncologist. 2015. PMID: 26446239 Free PMC article. Clinical Trial.
Expansion Cohorts in First-in-Human Solid Tumor Oncology Trials.
Theoret MR, Pai-Scherf LH, Chuk MK, Prowell TM, Balasubramaniam S, Kim T, Kim G, Kluetz PG, Keegan P, Pazdur R. Theoret MR, et al. Among authors: kluetz pg. Clin Cancer Res. 2015 Oct 15;21(20):4545-51. doi: 10.1158/1078-0432.CCR-14-3244. Clin Cancer Res. 2015. PMID: 26473190
Successes and Challenges of PARP Inhibitors in Cancer Therapy.
Ricks TK, Chiu HJ, Ison G, Kim G, McKee AE, Kluetz P, Pazdur R. Ricks TK, et al. Among authors: kluetz p. Front Oncol. 2015 Oct 14;5:222. doi: 10.3389/fonc.2015.00222. eCollection 2015. Front Oncol. 2015. PMID: 26528434 Free PMC article. Review. No abstract available.
171 results