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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: helms ws. Clin Cancer Res. 2022 Jun 1;28(11):2221-2228. doi: 10.1158/1078-0432.CCR-21-3844. Clin Cancer Res. 2022. PMID: 35101885
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. Hazarika M, et al. Among authors: helms ws. Clin Cancer Res. 2017 Jul 15;23(14):3484-3488. doi: 10.1158/1078-0432.CCR-16-0712. Epub 2017 Jan 13. Clin Cancer Res. 2017. PMID: 28087644 Clinical Trial.
FDA Approval Summary: TAS-102.
Marcus L, Lemery SJ, Khasar S, Wearne E, Helms WS, Yuan W, He K, Cao X, Yu J, Zhao H, Wang Y, Stephens O, Englund E, Agarwal R, Keegan P, Pazdur R. Marcus L, et al. Among authors: helms ws. Clin Cancer Res. 2017 Jun 15;23(12):2924-2927. doi: 10.1158/1078-0432.CCR-16-2157. Epub 2017 Feb 17. Clin Cancer Res. 2017. PMID: 28213365 Clinical Trial.
FDA Approval Summary: Trabectedin for Unresectable or Metastatic Liposarcoma or Leiomyosarcoma Following an Anthracycline-Containing Regimen.
Barone A, Chi DC, Theoret MR, Chen H, He K, Kufrin D, Helms WS, Subramaniam S, Zhao H, Patel A, Goldberg KB, Keegan P, Pazdur R. Barone A, et al. Among authors: helms ws. Clin Cancer Res. 2017 Dec 15;23(24):7448-7453. doi: 10.1158/1078-0432.CCR-17-0898. Epub 2017 Aug 3. Clin Cancer Res. 2017. PMID: 28774898 Clinical Trial.
FDA Approval Summary: Selpercatinib for the Treatment of Lung and Thyroid Cancers with RET Gene Mutations or Fusions.
Bradford D, Larkins E, Mushti SL, Rodriguez L, Skinner AM, Helms WS, Price LSL, Zirkelbach JF, Li Y, Liu J, Charlab R, Turcu FR, Liang D, Ghosh S, Roscoe D, Philip R, Zack-Taylor A, Tang S, Kluetz PG, Beaver JA, Pazdur R, Theoret MR, Singh H. Bradford D, et al. Among authors: helms ws. Clin Cancer Res. 2021 Apr 15;27(8):2130-2135. doi: 10.1158/1078-0432.CCR-20-3558. Epub 2020 Nov 25. Clin Cancer Res. 2021. PMID: 33239432
FDA Approval Summary: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer.
Singh S, Jaigirdar AA, Mulkey F, Cheng J, Hamed SS, Li Y, Liu J, Zhao H, Goheer A, Helms WS, Wang X, Agarwal R, Pragani R, Korsah K, Tang S, Leighton J, Rahman A, Beaver JA, Pazdur R, Theoret MR, Singh H. Singh S, et al. Among authors: helms ws. Clin Cancer Res. 2021 May 1;27(9):2378-2382. doi: 10.1158/1078-0432.CCR-20-3901. Epub 2020 Dec 7. Clin Cancer Res. 2021. PMID: 33288660 Free PMC article.
FDA Approval Summary: Selumetinib for Plexiform Neurofibroma.
Casey D, Demko S, Sinha A, Mishra-Kalyani PS, Shen YL, Khasar S, Goheer MA, Helms WS, Pan L, Xu Y, Fan J, Leong R, Liu J, Yang Y, Windsor K, Ou M, Stephens O, Oh B, Reaman GH, Nair A, Shord SS, Bhatnagar V, Daniels SR, Sickafuse S, Goldberg KB, Theoret MR, Pazdur R, Singh H. Casey D, et al. Among authors: helms ws. Clin Cancer Res. 2021 Aug 1;27(15):4142-4146. doi: 10.1158/1078-0432.CCR-20-5032. Epub 2021 Mar 12. Clin Cancer Res. 2021. PMID: 33712511
FDA Approval Summary: Pralsetinib for the Treatment of Lung and Thyroid Cancers With RET Gene Mutations or Fusions.
Kim J, Bradford D, Larkins E, Pai-Scherf LH, Chatterjee S, Mishra-Kalyani PS, Wearne E, Helms WS, Ayyoub A, Bi Y, Sun J, Charlab R, Liu J, Zhao H, Liang D, Ghosh S, Philip R, Pazdur R, Theoret MR, Beaver JA, Singh H. Kim J, et al. Among authors: helms ws. Clin Cancer Res. 2021 Oct 15;27(20):5452-5456. doi: 10.1158/1078-0432.CCR-21-0967. Epub 2021 May 27. Clin Cancer Res. 2021. PMID: 34045295
26 results