Mishra-Kalyani PS - Search Results

1

The FDA Oncology Center of Excellence Scientific Collaborative: Charting a Course for Applied Regulatory Science Research in Oncology.

Schneider JA, Gong Y, Goldberg KB, Kluetz PG, Theoret MR, Amiri-Kordestani L, Beaver JA, Fashoyin-Aje L, Gormley NJ, Jaigirdar AA, Lemery SJ, Mishra-Kalyani PS, Reaman GH, Rivera DR, Rubinstein WS, Singh H, Sridhara R, Pazdur R. Schneider JA, et al. Clin Cancer Res. 2021 Oct 1;27(19):5161-5167. doi: 10.1158/1078-0432.CCR-20-4429. Clin Cancer Res. 2021. PMID: 33910935 Free PMC article.

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. Barone A, et al. Clin Cancer Res. 2017 Oct 1;23(19):5661-5665. doi: 10.1158/1078-0432.CCR-16-0664. Epub 2017 Feb 8. Clin Cancer Res. 2017. PMID: 28179454 Clinical Trial.

3

FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non-Small Cell Lung Cancer: First-Line Therapy and Beyond.

Pai-Scherf L, Blumenthal GM, Li H, Subramaniam S, Mishra-Kalyani PS, He K, Zhao H, Yu J, Paciga M, Goldberg KB, McKee AE, Keegan P, Pazdur R. Pai-Scherf L, et al. Oncologist. 2017 Nov;22(11):1392-1399. doi: 10.1634/theoncologist.2017-0078. Epub 2017 Aug 23. Oncologist. 2017. PMID: 28835513 Free PMC article. Clinical Trial.

4

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

Jin S, Mishra-Kalyani PS, Sridhara R. Jin S, et al. Ther Innov Regul Sci. 2019 Jan;53(1):59-70. doi: 10.1177/2168479018769286. Epub 2018 Apr 24. Ther Innov Regul Sci. 2019. PMID: 29714599 Review.

5

FDA analyses of survival in older adults with metastatic non-small cell lung cancer in controlled trials of PD-1/PD-L1 blocking antibodies.

Marur S, Singh H, Mishra-Kalyani P, Larkins E, Keegan P, Sridhara R, Blumenthal GM, Pazdur R. Marur S, et al. Semin Oncol. 2018 Aug;45(4):220-225. doi: 10.1053/j.seminoncol.2018.08.007. Epub 2018 Oct 31. Semin Oncol. 2018. PMID: 30391014 Review.

6

Analysis of time-to-treatment discontinuation of targeted therapy, immunotherapy, and chemotherapy in clinical trials of patients with non-small-cell lung cancer.

Blumenthal GM, Gong Y, Kehl K, Mishra-Kalyani P, Goldberg KB, Khozin S, Kluetz PG, Oxnard GR, Pazdur R. Blumenthal GM, et al. Ann Oncol. 2019 May 1;30(5):830-838. doi: 10.1093/annonc/mdz060. Ann Oncol. 2019. PMID: 30796424 Free article.

7

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

Roydhouse JK, Gutman R, Bhatnagar V, Kluetz PG, Sridhara R, Mishra-Kalyani PS. Roydhouse JK, et al. Pharmacoepidemiol Drug Saf. 2019 Oct;28(10):1386-1394. doi: 10.1002/pds.4875. Epub 2019 Aug 13. Pharmacoepidemiol Drug Saf. 2019. PMID: 31410963

8

Global Variation in Opioid Use in Prostate Cancer Trials.

Roydhouse JK, Suzman DL, Menapace LA, Mishra-Kalyani PS, Sridhara R, Blumenthal GM, Beaver JA, Pazdur R, Kluetz PG. Roydhouse JK, et al. JAMA Oncol. 2019 Nov 1;5(11):e192971. doi: 10.1001/jamaoncol.2019.2971. Epub 2019 Nov 14. JAMA Oncol. 2019. PMID: 31513232 Free PMC article.

9

FDA Accelerated Approval of Pembrolizumab for Recurrent Locally Advanced or Metastatic Merkel Cell Carcinoma.

Bradford D, Demko S, Jin S, Mishra-Kalyani P, Beckles AR, Goldberg KB, Lemery S, Ward A, Keegan P, Pazdur R. Bradford D, et al. Oncologist. 2020 Jul;25(7):e1077-e1082. doi: 10.1634/theoncologist.2020-0184. Epub 2020 Apr 28. Oncologist. 2020. PMID: 32272501 Free PMC article.

10

FDA Approval Summary: Atezolizumab and Durvalumab in Combination with Platinum-Based Chemotherapy in Extensive Stage Small Cell Lung Cancer.

Mathieu L, Shah S, Pai-Scherf L, Larkins E, Vallejo J, Li X, Rodriguez L, Mishra-Kalyani P, Goldberg KB, Kluetz PG, Theoret MR, Beaver JA, Pazdur R, Singh H. Mathieu L, et al. Oncologist. 2021 May;26(5):433-438. doi: 10.1002/onco.13752. Epub 2021 Mar 25. Oncologist. 2021. PMID: 33687763 Free PMC article. Review.

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