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FDA Approval Summary: Olaparib Monotherapy in Patients with Deleterious Germline BRCA-Mutated Advanced Ovarian Cancer Treated with Three or More Lines of Chemotherapy.
Kim G, Ison G, McKee AE, Zhang H, Tang S, Gwise T, Sridhara R, Lee E, Tzou A, Philip R, Chiu HJ, Ricks TK, Palmby T, Russell AM, Ladouceur G, Pfuma E, Li H, Zhao L, Liu Q, Venugopal R, Ibrahim A, Pazdur R. Kim G, et al. Among authors: lee e. Clin Cancer Res. 2015 Oct 1;21(19):4257-61. doi: 10.1158/1078-0432.CCR-15-0887. Epub 2015 Jul 17. Clin Cancer Res. 2015. PMID: 26187614 Review.
FDA Approval Summary: Rucaparib for the Treatment of Patients with Deleterious BRCA Mutation-Associated Advanced Ovarian Cancer.
Balasubramaniam S, Beaver JA, Horton S, Fernandes LL, Tang S, Horne HN, Liu J, Liu C, Schrieber SJ, Yu J, Song P, Pierce W, Robertson KJ, Palmby TR, Chiu HJ, Lee EY, Philip R, Schuck R, Charlab R, Banerjee A, Chen XH, Wang X, Goldberg KB, Sridhara R, Kim G, Pazdur R. Balasubramaniam S, et al. Clin Cancer Res. 2017 Dec 1;23(23):7165-7170. doi: 10.1158/1078-0432.CCR-17-1337. Epub 2017 Jul 27. Clin Cancer Res. 2017. PMID: 28751443
FDA Approval Summary: Niraparib for the Maintenance Treatment of Patients with Recurrent Ovarian Cancer in Response to Platinum-Based Chemotherapy.
Ison G, Howie LJ, Amiri-Kordestani L, Zhang L, Tang S, Sridhara R, Pierre V, Charlab R, Ramamoorthy A, Song P, Li F, Yu J, Manheng W, Palmby TR, Ghosh S, Horne HN, Lee EY, Philip R, Dave K, Chen XH, Kelly SL, Janoria KG, Banerjee A, Eradiri O, Dinin J, Goldberg KB, Pierce WF, Ibrahim A, Kluetz PG, Blumenthal GM, Beaver JA, Pazdur R. Ison G, et al. Clin Cancer Res. 2018 Sep 1;24(17):4066-4071. doi: 10.1158/1078-0432.CCR-18-0042. Epub 2018 Apr 12. Clin Cancer Res. 2018. PMID: 29650751
FDA Benefit-Risk Assessment of Osimertinib for the Treatment of Metastatic Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor T790M Mutation.
Odogwu L, Mathieu L, Goldberg KB, Blumenthal GM, Larkins E, Fiero MH, Rodriguez L, Bijwaard K, Lee EY, Philip R, Fan I, Donoghue M, Keegan P, McKee A, Pazdur R. Odogwu L, et al. Among authors: lee ey. Oncologist. 2018 Mar;23(3):353-359. doi: 10.1634/theoncologist.2017-0425. Epub 2017 Dec 14. Oncologist. 2018. PMID: 29242281 Free PMC article. Clinical Trial.
FDA Approval Summary: Dabrafenib and Trametinib for the Treatment of Metastatic Non-Small Cell Lung Cancers Harboring BRAF V600E Mutations.
Odogwu L, Mathieu L, Blumenthal G, Larkins E, Goldberg KB, Griffin N, Bijwaard K, Lee EY, Philip R, Jiang X, Rodriguez L, McKee AE, Keegan P, Pazdur R. Odogwu L, et al. Among authors: lee ey. Oncologist. 2018 Jun;23(6):740-745. doi: 10.1634/theoncologist.2017-0642. Epub 2018 Feb 7. Oncologist. 2018. PMID: 29438093 Free PMC article.
Weighing the Evidence: Variant Classification and Interpretation in Precision Oncology, US Food and Drug Administration Public Workshop-Workshop Proceedings.
Horne HN, Roscoe D, Litwack ED, Pathak A, Pandey JP, Gallagher PS, Koontz LM, Schuck RN, Lee EY, Hu YF, Beaver JA, Blumenthal GM, Philip R. Horne HN, et al. Among authors: lee ey. JCO Precis Oncol. 2019 Mar 19;3:PO.18.00314. doi: 10.1200/PO.18.00314. eCollection 2019. JCO Precis Oncol. 2019. PMID: 32914013 Free PMC article.
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