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Page 1
FDA Approval Summary: Belzutifan for VHL Disease Tumors-Response.
Fallah J, Weinstock C, Mehta GU, Brave MH, Pierce WF, Pazdur R, Nair A, Suzman DL, Amiri-Kordestani L. Fallah J, et al. Among authors: mehta gu. Clin Cancer Res. 2023 Feb 1;29(3):685. doi: 10.1158/1078-0432.CCR-22-3428. Clin Cancer Res. 2023. PMID: 36722139 No abstract available.
US Food and Drug Administration regulatory updates in neuro-oncology.
Mehta GU, Barone AK, Bradford D, Larkins E, Kim J, Pai-Scherf L, Jaigirdar A, Shah M, Wedam S, Amiri-Kordestani L, Theoret MR, Pazdur R, Beaver JA, Singh H. Mehta GU, et al. J Neurooncol. 2021 Jul;153(3):375-381. doi: 10.1007/s11060-021-03789-5. Epub 2021 Jun 22. J Neurooncol. 2021. PMID: 34156585 Free PMC article. Review.
FDA Approval Summary: Belzutifan for von Hippel-Lindau Disease-Associated Tumors.
Fallah J, Brave MH, Weinstock C, Mehta GU, Bradford D, Gittleman H, Bloomquist EW, Charlab R, Hamed SS, Miller CP, Dorff SE, Chambers WA, Mixter BD, Dinin J, Pierce WF, Ricks TK, Tang S, Donoghue M, Pazdur R, Amiri-Kordestani L, Ibrahim A, Beaver JA. Fallah J, et al. Among authors: mehta gu. Clin Cancer Res. 2022 Nov 14;28(22):4843-4848. doi: 10.1158/1078-0432.CCR-22-1054. Clin Cancer Res. 2022. PMID: 35727604 Free PMC article.
The On- and Off-Ramps of Oncology Accelerated Approval.
Fashoyin-Aje LA, Mehta GU, Beaver JA, Pazdur R. Fashoyin-Aje LA, et al. Among authors: mehta gu. N Engl J Med. 2022 Oct 20;387(16):1439-1442. doi: 10.1056/NEJMp2208954. Epub 2022 Sep 21. N Engl J Med. 2022. PMID: 36129992 No abstract available.
Accelerated approvals hit the target in precision oncology.
Subbiah V, Wirth LJ, Kurzrock R, Pazdur R, Beaver JA, Singh H, Mehta GU. Subbiah V, et al. Among authors: mehta gu. Nat Med. 2022 Oct;28(10):1976-1979. doi: 10.1038/s41591-022-01984-z. Nat Med. 2022. PMID: 36192554 No abstract available.
Project Confirm: Accelerated Drug Approvals for Chronic Myeloid Leukemia.
Sweet KL, Cortes JE, Apperley JF, Mann M, Mauro MJ, Oehler VG, Ruiz C, Schiffer CA, Ehrlich LA, Pamuk GE, Wynne J, Mehta GU, de Claro RA, Theoret MR, Smith BD, Norsworthy KJ. Sweet KL, et al. Among authors: mehta gu. Clin Cancer Res. 2023 Jun 13;29(12):2179-2183. doi: 10.1158/1078-0432.CCR-22-2628. Clin Cancer Res. 2023. PMID: 36547666 Free PMC article.
FDA approval summary: fam-trastuzumab deruxtecan-nxki for unresectable or metastatic non-small cell lung cancer with activating HER2 mutations.
Mehta GU, Vellanki PJ, Ren Y, Amatya AK, Mishra-Kalyani PS, Pan L, Zirkelbach JF, Pan Y, Liu J, Aungst SL, Miller CP, Shah M, Rahman NA, Theoret M, Kluetz P, Pazdur R, Beaver JA, Singh H. Mehta GU, et al. Oncologist. 2024 Aug 5;29(8):667-671. doi: 10.1093/oncolo/oyae151. Oncologist. 2024. PMID: 38970465 Free PMC article. Clinical Trial.
Project Confirm: Accelerated Drug Approvals for CML-Response.
Sweet KL, Cortes JE, Apperley JF, Mann M, Mauro MJ, Oehler VG, Ruiz C, Schiffer CA, Ehrlich LA, Pamuk GE, Wynne J, Mehta GU, Okusanya OO, de Claro RA, Theoret MR, Smith BD, Norsworthy KJ. Sweet KL, et al. Among authors: mehta gu. Clin Cancer Res. 2024 Jan 5;30(1):237-238. doi: 10.1158/1078-0432.CCR-23-3234. Clin Cancer Res. 2024. PMID: 38178776 Free PMC article. No abstract available.
91 results