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FDA Approval Summary: Ivosidenib for relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase-1 mutation.

Norsworthy KJ, Luo L, Hsu V, Gudi R, Dorff SE, Przepiorka D, Deisseroth A, Shen YL, Sheth CM, Charlab R, Williams GM, Goldberg KB, Farrell AT, Pazdur R.

Clin Cancer Res. 2019 Jan 28. pii: clincanres.3749.2018. doi: 10.1158/1078-0432.CCR-18-3749. [Epub ahead of print]


Impact of Hemolysis on Acute Kidney Injury and Mortality in Children Supported with Cardiac Extracorporeal Membrane Oxygenation.

Borasino S, Kalra Y, Elam AR, Carlisle O'Meara L, Timpa JG, Goldberg KG, Collins Gaddis JL, Alten JA.

J Extra Corpor Technol. 2018 Dec;50(4):217-224.


FDA Approval Summary: Pertuzumab for adjuvant treatment of HER2-positive early breast cancer.

Howie LJ, Scher NS, Amiri-Kordestani L, Zhang L, King-Kallimanis BL, Choudhry Y, Schroeder J, Goldberg KB, Kluetz PG, Ibrahim A, Sridhara R, Blumenthal GM, Pazdur R, Beaver JA.

Clin Cancer Res. 2018 Dec 14. pii: clincanres.3003.2018. doi: 10.1158/1078-0432.CCR-18-3003. [Epub ahead of print]


FDA Approval Summary: Atezolizumab or Pembrolizumab for the Treatment of Patients with Advanced Urothelial Carcinoma Ineligible for Cisplatin-Containing Chemotherapy.

Suzman DL, Agrawal S, Ning YM, Maher VE, Fernandes LL, Karuri S, Tang S, Sridhara R, Schroeder J, Goldberg KB, Ibrahim A, McKee AE, Pazdur R, Beaver JA.

Oncologist. 2018 Dec 12. pii: theoncologist.2018-0084. doi: 10.1634/theoncologist.2018-0084. [Epub ahead of print]


FDA Approval Summary: (Daunorubicin and Cytarabine) Liposome for Injection for the Treatment of Adults with High-Risk Acute Myeloid Leukemia.

Krauss AC, Gao X, Li L, Manning ML, Patel P, Fu W, Janoria KG, Gieser G, Bateman DA, Przepiorka D, Shen YL, Shord SS, Sheth CM, Banerjee A, Liu J, Goldberg KB, Farrell AT, Blumenthal GM, Pazdur R.

Clin Cancer Res. 2018 Dec 12. doi: 10.1158/1078-0432.CCR-18-2990. [Epub ahead of print]


Examining Commonly Reported Sex Trafficking Indicators From Practitioners' Perspectives: Findings From a Pilot Study.

Gerassi LB, Nichols AJ, Cox A, Goldberg KK, Tang C.

J Interpers Violence. 2018 Nov 28:886260518812813. doi: 10.1177/0886260518812813. [Epub ahead of print]


Optimal sampling scheme in men with abnormal multiparametric MRI undergoing MRI-TRUS fusion prostate biopsy.

Freifeld Y, Xi Y, Passoni N, Woldu S, Hornberger B, Goldberg K, Bagrodia A, Raj G, Margulis V, Cadeddu JA, Lotan Y, Francis F, Pedrosa I, G Roehrborn C, Costa DN.

Urol Oncol. 2019 Jan;37(1):57-62. doi: 10.1016/j.urolonc.2018.10.009. Epub 2018 Nov 13.


Prospective Inclusion of Apparent Diffusion Coefficients in Multiparametric Prostate MRI Structured Reports: Discrimination of Clinically Insignificant and Significant Cancers.

Costa DN, Xi Y, Aziz M, Passoni N, Shakir N, Goldberg K, Francis F, Roehrborn CG, Leon AD, Pedrosa I.

AJR Am J Roentgenol. 2019 Jan;212(1):109-116. doi: 10.2214/AJR.18.19937. Epub 2018 Nov 1.


The Unexpected Essentiality of glnA2 in Mycobacterium smegmatis Is Salvaged by Overexpression of the Global Nitrogen Regulator glnR, but Not by L-, D- or Iso-Glutamine.

Rakovitsky N, Bar Oz M, Goldberg K, Gibbons S, Zimhony O, Barkan D.

Front Microbiol. 2018 Sep 11;9:2143. doi: 10.3389/fmicb.2018.02143. eCollection 2018.


Discovery of N-(4-{[5-Fluoro-7-(2-methoxyethoxy)quinazolin-4-yl]amino}phenyl)-2-[4-(propan-2-yl)-1 H-1,2,3-triazol-1-yl]acetamide (AZD3229), a Potent Pan-KIT Mutant Inhibitor for the Treatment of Gastrointestinal Stromal Tumors.

Kettle JG, Anjum R, Barry E, Bhavsar D, Brown C, Boyd S, Campbell A, Goldberg K, Grondine M, Guichard S, Hardy CJ, Hunt T, Jones RDO, Li X, Moleva O, Ogg D, Overman RC, Packer MJ, Pearson S, Schimpl M, Shao W, Smith A, Smith JM, Stead D, Stokes S, Tucker M, Ye Y.

J Med Chem. 2018 Oct 11;61(19):8797-8810. doi: 10.1021/acs.jmedchem.8b00938. Epub 2018 Sep 24.


Discovery of a Series of 3-Cinnoline Carboxamides as Orally Bioavailable, Highly Potent, and Selective ATM Inhibitors.

Barlaam B, Cadogan E, Campbell A, Colclough N, Dishington A, Durant S, Goldberg K, Hassall LA, Hughes GD, MacFaul PA, McGuire TM, Pass M, Patel A, Pearson S, Petersen J, Pike KG, Robb G, Stratton N, Xin G, Zhai B.

ACS Med Chem Lett. 2018 Jul 13;9(8):809-814. doi: 10.1021/acsmedchemlett.8b00200. eCollection 2018 Aug 9.


FDA Approval Summary: Pembrolizumab for Recurrent Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing PD-L1.

Fashoyin-Aje L, Donoghue M, Chen H, He K, Veeraraghavan J, Goldberg KB, Keegan P, McKee AE, Pazdur R.

Oncologist. 2019 Jan;24(1):103-109. doi: 10.1634/theoncologist.2018-0221. Epub 2018 Aug 17.


FDA Approval Summary: Vemurafenib for the Treatment of Patients with Erdheim-Chester Disease with the BRAFV600 Mutation.

Oneal PA, Kwitkowski V, Luo L, Shen YL, Subramaniam S, Shord S, Goldberg KB, McKee AE, Kaminskas E, Farrell A, Pazdur R.

Oncologist. 2018 Dec;23(12):1520-1524. doi: 10.1634/theoncologist.2018-0295. Epub 2018 Aug 17.


FDA Supplemental Approval: Blinatumomab for Treatment of Relapsed and Refractory Precursor B-Cell Acute Lymphoblastic Leukemia.

Pulte ED, Vallejo J, Przepiorka D, Nie L, Farrell AT, Goldberg KB, McKee AE, Pazdur R.

Oncologist. 2018 Nov;23(11):1366-1371. doi: 10.1634/theoncologist.2018-0179. Epub 2018 Jul 17.


The First Year of the Food and Drug Administration Oncology Center of Excellence: Landmark Approvals in a Dynamic Regulatory Environment.

Goldberg KB, Blumenthal GM, Pazdur R.

Cancer J. 2018 May/Jun;24(3):131-135. doi: 10.1097/PPO.0000000000000316.


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.

Clin Cancer Res. 2018 Sep 1;24(17):4066-4071. doi: 10.1158/1078-0432.CCR-18-0042. Epub 2018 Apr 12.


Description, evaluation and scale-up potential of a model for rapid access to early intervention for psychosis.

MacDonald K, Malla A, Joober R, Shah JL, Goldberg K, Abadi S, Doyle M, Iyer SN.

Early Interv Psychiatry. 2018 Dec;12(6):1222-1228. doi: 10.1111/eip.12564. Epub 2018 Mar 26.


Baby or bathwater? Referrals of "non-cases" in a targeted early identification intervention for psychosis.

Jordan G, Kinkaid M, Iyer SN, Joober R, Goldberg K, Malla A, Shah JL.

Soc Psychiatry Psychiatr Epidemiol. 2018 Jul;53(7):757-761. doi: 10.1007/s00127-018-1502-5. Epub 2018 Mar 14.


US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments.

Wedam SB, Beaver JA, Amiri-Kordestani L, Bloomquist E, Tang S, Goldberg KB, Sridhara R, Ibrahim A, Kim G, Kluetz P, McKee A, Pazdur R.

J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9.


A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics: A Review.

Beaver JA, Howie LJ, Pelosof L, Kim T, Liu J, Goldberg KB, Sridhara R, Blumenthal GM, Farrell AT, Keegan P, Pazdur R, Kluetz PG.

JAMA Oncol. 2018 Jun 1;4(6):849-856. doi: 10.1001/jamaoncol.2017.5618.


FDA Approval Summary: Lenalidomide as Maintenance Therapy After Autologous Stem Cell Transplant in Newly Diagnosed Multiple Myeloma.

Pulte ED, Dmytrijuk A, Nie L, Goldberg KB, McKee AE, Farrell AT, Pazdur R.

Oncologist. 2018 Jun;23(6):734-739. doi: 10.1634/theoncologist.2017-0440. Epub 2018 Feb 7.


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.

Oncologist. 2018 Jun;23(6):740-745. doi: 10.1634/theoncologist.2017-0642. Epub 2018 Feb 7.


FDA Approval: Ribociclib for the Treatment of Postmenopausal Women with Hormone Receptor-Positive, HER2-Negative Advanced or Metastatic Breast Cancer.

Shah A, Bloomquist E, Tang S, Fu W, Bi Y, Liu Q, Yu J, Zhao P, Palmby TR, Goldberg KB, Chang CJG, Patel P, Alebachew E, Tilley A, Pierce WF, Ibrahim A, Blumenthal GM, Sridhara R, Beaver JA, Pazdur R.

Clin Cancer Res. 2018 Jul 1;24(13):2999-3004. doi: 10.1158/1078-0432.CCR-17-2369. Epub 2018 Feb 7.


Objectively Measured Baseline Physical Activity Patterns in Women in the mPED Trial: Cluster Analysis.

Fukuoka Y, Zhou M, Vittinghoff E, Haskell W, Goldberg K, Aswani A.

JMIR Public Health Surveill. 2018 Feb 1;4(1):e10. doi: 10.2196/publichealth.9138.


Benefit-Risk Summary of Regorafenib for the Treatment of Patients with Advanced Hepatocellular Carcinoma That Has Progressed on Sorafenib.

Pelosof L, Lemery S, Casak S, Jiang X, Rodriguez L, Pierre V, Bi Y, Liu J, Zirkelbach JF, Patel A, Goldberg KB, McKee AE, Keegan P, Pazdur R.

Oncologist. 2018 Apr;23(4):496-500. doi: 10.1634/theoncologist.2017-0422. Epub 2018 Jan 31.


Fexapotide triflutate: results of long-term safety and efficacy trials of a novel injectable therapy for symptomatic prostate enlargement.

Shore N, Tutrone R, Efros M, Bidair M, Wachs B, Kalota S, Freedman S, Bailen J, Levin R, Richardson S, Kaminetsky J, Snyder J, Shepard B, Goldberg K, Hay A, Gange S, Grunberger I.

World J Urol. 2018 May;36(5):801-809. doi: 10.1007/s00345-018-2185-y. Epub 2018 Jan 29.


Plasma Activation of a Breast Implant Shell in Conjunction With Antibacterial Irrigants Enhances Antibacterial Activity.

Barnea Y, Hammond DC, Geffen Y, Navon-Venezia S, Goldberg K.

Aesthet Surg J. 2018 Oct 15;38(11):1188-1196. doi: 10.1093/asj/sjy020.


Evaluating Machine Learning-Based Automated Personalized Daily Step Goals Delivered Through a Mobile Phone App: Randomized Controlled Trial.

Zhou M, Fukuoka Y, Mintz Y, Goldberg K, Kaminsky P, Flowers E, Aswani A.

JMIR Mhealth Uhealth. 2018 Jan 25;6(1):e28. doi: 10.2196/mhealth.9117.


Survival of ethnic and racial minority patients with multiple myeloma treated with newer medications.

Pulte ED, Nie L, Gormley N, Goldberg KB, McKee A, Farrell A, Pazdur R.

Blood Adv. 2018 Jan 23;2(2):116-119. doi: 10.1182/bloodadvances.2017010512. No abstract available.


Patients with melanoma treated with an anti-PD-1 antibody beyond RECIST progression: a US Food and Drug Administration pooled analysis.

Beaver JA, Hazarika M, Mulkey F, Mushti S, Chen H, He K, Sridhara R, Goldberg KB, Chuk MK, Chi DC, Chang J, Barone A, Balasubramaniam S, Blumenthal GM, Keegan P, Pazdur R, Theoret MR.

Lancet Oncol. 2018 Feb;19(2):229-239. doi: 10.1016/S1470-2045(17)30846-X. Epub 2018 Jan 18. Review.


Convective radiofrequency water vapor thermal therapy for benign prostatic hyperplasia: a single office experience.

Mollengarden D, Goldberg K, Wong D, Roehrborn C.

Prostate Cancer Prostatic Dis. 2018 Sep;21(3):379-385. doi: 10.1038/s41391-017-0022-9. Epub 2017 Dec 27.


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.

Oncologist. 2018 Mar;23(3):353-359. doi: 10.1634/theoncologist.2017-0425. Epub 2017 Dec 14.


Accelerating Early Access to Immunotherapies for Advanced Urothelial Carcinoma.

Ning YM, Maher VE, Beaver JA, Goldberg KB, Blumenthal GM, Pazdur R.

Oncologist. 2018 Feb;23(2):139-142. doi: 10.1634/theoncologist.2017-0415. Epub 2017 Nov 27. No abstract available.


The FDA Oncology Center of Excellence and precision medicine.

Goldberg KB, Blumenthal GM, McKee AE, Pazdur R.

Exp Biol Med (Maywood). 2018 Feb;243(3):308-312. doi: 10.1177/1535370217740861. Epub 2017 Nov 6. Review.


CIRCADIAN CLOCK ASSOCIATED1 (CCA1) and the Circadian Control of Stomatal Aperture.

Hassidim M, Dakhiya Y, Turjeman A, Hussien D, Shor E, Anidjar A, Goldberg K, Green RM.

Plant Physiol. 2017 Dec;175(4):1864-1877. doi: 10.1104/pp.17.01214. Epub 2017 Oct 30.


Large-Scale Selective Functionalization of Alkanes.

Goldberg KI, Goldman AS.

Acc Chem Res. 2017 Mar 21;50(3):620-626. doi: 10.1021/acs.accounts.6b00621.


The art of the deposition: Teaching residents about medical liability.

Goldberg RF, Goldberg KD, Caruso D.

Bull Am Coll Surg. 2017 Feb;102(2):39-42. No abstract available.


Exploring caregiver burden within a veterinary setting.

Goldberg KJ.

Vet Rec. 2017 Sep 21;181(12):318-319. doi: 10.1136/vr.j4156. Epub 2017 Sep 18. No abstract available.


FDA Approval Summary: Daratumumab for Treatment of Multiple Myeloma After One Prior Therapy.

Bhatnagar V, Gormley NJ, Luo L, Shen YL, Sridhara R, Subramaniam S, Shen G, Ma L, Shord S, Goldberg KB, Farrell AT, McKee AE, Pazdur R.

Oncologist. 2017 Nov;22(11):1347-1353. doi: 10.1634/theoncologist.2017-0229. Epub 2017 Sep 13.


Detection of an Iridium-Dihydrogen Complex: A Proposed Intermediate in Ionic Hydrogenation.

Goldberg JM, Goldberg KI, Heinekey DM, Burgess SA, Lao DB, Linehan JC.

J Am Chem Soc. 2017 Sep 13;139(36):12638-12646. doi: 10.1021/jacs.7b06480. Epub 2017 Sep 1.


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.

Oncologist. 2017 Nov;22(11):1392-1399. doi: 10.1634/theoncologist.2017-0078. Epub 2017 Aug 23.


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.

Clin Cancer Res. 2017 Dec 15;23(24):7448-7453. doi: 10.1158/1078-0432.CCR-17-0898. Epub 2017 Aug 3.


Flexibility and innovation in the FDA's novel regulatory approval strategies for hematologic drugs.

Farrell AT, Goldberg KB, Pazdur R.

Blood. 2017 Sep 14;130(11):1285-1289. doi: 10.1182/blood-2017-04-742726. Epub 2017 Aug 3. No abstract available. Erratum in: Blood. 2018 Apr 19;131(16):1875-1876.


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.

Clin Cancer Res. 2017 Dec 1;23(23):7165-7170. doi: 10.1158/1078-0432.CCR-17-1337. Epub 2017 Jul 27.


Milestone Analyses of Immune Checkpoint Inhibitors, Targeted Therapy, and Conventional Therapy in Metastatic Non-Small Cell Lung Cancer Trials: A Meta-analysis.

Blumenthal GM, Zhang L, Zhang H, Kazandjian D, Khozin S, Tang S, Goldberg K, Sridhara R, Keegan P, Pazdur R.

JAMA Oncol. 2017 Aug 10;3(8):e171029. doi: 10.1001/jamaoncol.2017.1029. Epub 2017 Aug 10.


U.S. Food and Drug Administration Approval Summary: Atezolizumab for Metastatic Non-Small Cell Lung Cancer.

Weinstock C, Khozin S, Suzman D, Zhang L, Tang S, Wahby S, Goldberg KB, Kim G, Pazdur R.

Clin Cancer Res. 2017 Aug 15;23(16):4534-4539. doi: 10.1158/1078-0432.CCR-17-0540. Epub 2017 Jun 13.


Oncology Drug Approvals: Evaluating Endpoints and Evidence in an Era of Breakthrough Therapies.

Blumenthal GM, Kluetz PG, Schneider J, Goldberg KB, McKee AE, Pazdur R.

Oncologist. 2017 Jul;22(7):762-767. doi: 10.1634/theoncologist.2017-0152. Epub 2017 Jun 2. No abstract available.


Direct Formation of Carbon(sp3)-Heteroatom Bonds from RhIII To Produce Methyl Iodide, Thioethers, and Alkylamines.

Stevens TE, Smoll KA, Goldberg KI.

J Am Chem Soc. 2017 Jun 14;139(23):7725-7728. doi: 10.1021/jacs.7b04169. Epub 2017 Jun 2.


Strategies to Maximize Patient Participation in Clinical Trials.

Rubin EH, Scroggins MJ, Goldberg KB, Beaver JA.

Am Soc Clin Oncol Educ Book. 2017;37:216-221. doi: 10.14694/EDBK_179803.


FDA Approval Summary: Pembrolizumab for the Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma with Disease Progression on or After Platinum-Containing Chemotherapy.

Larkins E, Blumenthal GM, Yuan W, He K, Sridhara R, Subramaniam S, Zhao H, Liu C, Yu J, Goldberg KB, McKee AE, Keegan P, Pazdur R.

Oncologist. 2017 Jul;22(7):873-878. doi: 10.1634/theoncologist.2016-0496. Epub 2017 May 22.

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