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The Friends of Cancer Research Real-World Data Collaboration Pilot 2.0: Methodological Recommendations from Oncology Case Studies.
Rivera DR, Henk HJ, Garrett-Mayer E, Christian JB, Belli AJ, Bruinooge SS, Espirito JL, Sweetnam C, Izano MA, Natanzon Y, Robert NJ, Walker MS, Cohen AB, Boyd M, Enewold L, Hansen E, Honnold R, Kushi L, Mishra Kalyani PS, Pe Benito R, Sakoda LC, Sharon E, Tymejczyk O, Valice E, Wagner J, Lasiter L, Allen JD. Rivera DR, et al. Among authors: mishra kalyani ps. Clin Pharmacol Ther. 2022 Jan;111(1):283-292. doi: 10.1002/cpt.2453. Epub 2021 Nov 11. Clin Pharmacol Ther. 2022. PMID: 34664259 Free PMC article.
Arm pain in youth baseball players: a survey of healthy players.
Makhni EC, Morrow ZS, Luchetti TJ, Mishra-Kalyani PS, Gualtieri AP, Lee RW, Ahmad CS. Makhni EC, et al. Among authors: mishra kalyani ps. Am J Sports Med. 2015 Jan;43(1):41-6. doi: 10.1177/0363546514555506. Epub 2014 Nov 3. Am J Sports Med. 2015. PMID: 25367016
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. Among authors: mishra kalyani ps. 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.
Treatment-related toxicity and improved outcome from immunotherapy in hepatocellular cancer: Evidence from an FDA pooled analysis of landmark clinical trials with validation from routine practice.
Pinato DJ, Marron TU, Mishra-Kalyani PS, Gong Y, Wei G, Szafron D, Sharon E, Saeed A, Jun T, Dharmapuri S, Naqash AR, Peeraphatdit T, Gampa A, Wang Y, Khan U, Muzaffar M, Navaid M, Lee CJ, Lee PC, Bulumulle A, Yu B, Paul S, Nimkar N, Bettinger D, Hildebrand H, Abugabal YI, Pressiani T, Personeni N, D'Alessio A, Kaseb AO, Huang YH, Ang C, Schneider J, Pillai A, Rimassa L, Goldberg KB, Pazdur R, Theoret M, Lemery S, Fashoyin-Aje ', Cortellini A, Pelosof L. Pinato DJ, et al. Among authors: mishra kalyani ps. Eur J Cancer. 2021 Nov;157:140-152. doi: 10.1016/j.ejca.2021.08.020. Epub 2021 Sep 8. Eur J Cancer. 2021. PMID: 34508996
External control arms in oncology: current use and future directions.
Mishra-Kalyani PS, Amiri Kordestani L, Rivera DR, Singh H, Ibrahim A, DeClaro RA, Shen Y, Tang S, Sridhara R, Kluetz PG, Concato J, Pazdur R, Beaver JA. Mishra-Kalyani PS, et al. Ann Oncol. 2022 Apr;33(4):376-383. doi: 10.1016/j.annonc.2021.12.015. Epub 2022 Jan 10. Ann Oncol. 2022. PMID: 35026413 Free article. Review.
The Association Between Baseline Hepatic or Renal Function and Clinical Outcomes for Patients With Non-Small Cell Lung Cancer Treated With a PD-1/PD-L1 Blocking Antibody Using Real-World and Trial Data.
Liu Q, Mathur R, Xu Y, Torres AZ, Miksad RA, Liu C, Smithson H, Wang Y, Zhu H, Booth B, Huang SM, Zhi J, Sridhara R, Blumenthal GM, Larkins E, Mishra-Kalyani PS, Rivera DR, Kluetz PG, Sharon E. Liu Q, et al. Among authors: mishra kalyani ps. Clin Pharmacol Ther. 2023 May;113(5):1139-1149. doi: 10.1002/cpt.2874. Epub 2023 Mar 13. Clin Pharmacol Ther. 2023. PMID: 36790088
FDA Approval Summary: Sotorasib for KRAS G12C-Mutated Metastatic NSCLC.
Nakajima EC, Drezner N, Li X, Mishra-Kalyani PS, Liu Y, Zhao H, Bi Y, Liu J, Rahman A, Wearne E, Ojofeitimi I, Hotaki LT, Spillman D, Pazdur R, Beaver JA, Singh H. Nakajima EC, et al. Among authors: mishra kalyani ps. Clin Cancer Res. 2022 Apr 14;28(8):1482-1486. doi: 10.1158/1078-0432.CCR-21-3074. Clin Cancer Res. 2022. PMID: 34903582 Free PMC article.
FDA Approval Summary: Pembrolizumab, Atezolizumab, and Cemiplimab-rwlc as Single Agents for First-Line Treatment of Advanced/Metastatic PD-L1-High NSCLC.
Akinboro O, Larkins E, Pai-Scherf LH, Mathieu LN, Ren Y, Cheng J, Fiero MH, Fu W, Bi Y, Kalavar S, Jafri S, Mishra-Kalyani PS, Fourie Zirkelbach J, Li H, Zhao H, He K, Helms WS, Chuk MK, Wang M, Bulatao I, Herz J, Osborn BL, Xu Y, Liu J, Gong Y, Sickafuse S, Cohen R, Donoghue M, Pazdur R, Beaver JA, Singh H. Akinboro O, et al. Among authors: mishra kalyani ps. Clin Cancer Res. 2022 Jun 1;28(11):2221-2228. doi: 10.1158/1078-0432.CCR-21-3844. Clin Cancer Res. 2022. PMID: 35101885
36 results