An FDA oncology analysis of antibody-drug conjugates von Saber, Haleh, Leighton, John K.

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An FDA oncology analysis of toxicities associated with PBD-containing antibody-drug conjugates von Saber, Haleh, Simpson, Natalie, Ricks, Tiffany K., Leighton, John K.

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Pharmacokinetic models for first-in-human dose selection of immune-activating products in oncology von Saber, Haleh, Thompson, Matthew D., Leighton, John K.

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An FDA oncology analysis of CD3 bispecific constructs and first-in-human dose selection von Saber, Haleh, Del Valle, Pedro, Ricks, Tiffany K., Leighton, John K.

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An FDA oncology analysis of immune activating products and first-in-human dose selection von Saber, Haleh, Gudi, Ramadevi, Manning, Michael, Wearne, Emily, Leighton, John K.

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FDA Approval Summary: Cabozantinib for Differentiated Thyroid Cancer von Duke, Elizabeth S, Barone, Amy K, Chatterjee, Somak, Mishra-Kalyani, Pallavi S, Shen, Yuan-Li, Isikwei, Emasenyie, Zhao, Hong, Bi, Youwei, Liu, Jiang, Rahman, Nam Atiqur, Wearne, Emily, Leighton, John K, Stephenson, Maritsa, Ojofeitimi, Idara, Scepura, Barbara, Nair, Abhilasha, Pazdur, Richard, Beaver, Julia A, Singh, Harpreet

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FDA Approval Summary: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer von Singh, Sonia, Jaigirdar, Adnan A, Mulkey, Flora, Cheng, Joyce, Hamed, Salaheldin S, Li, Yangbing, Liu, Jiang, Zhao, Hong, Goheer, Anwar, Helms, Whitney S, Wang, Xing, Agarwal, Rajiv, Pragani, Rajan, Korsah, Kwadwo, Tang, Shenghui, Leighton, John, Rahman, Atiqur, Beaver, Julia A, Pazdur, Richard, Theoret, Marc R, Singh, Harpreet

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Summary of a workshop on preclinical and translational safety assessment of CD3 bispecifics von Kamperschroer, Cris, Shenton, Jacintha, Lebrec, Hervé, Leighton, John K., Moore, Paul A., Thomas, Oliver

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Controversies in antiepidermal growth factor receptor therapy in metastatic colorectal cancer von Woo, Janghee, Palmisiano, Neil, Tester, William, Leighton, John C.

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FDA Approval Summary: Margetuximab plus Chemotherapy for Advanced or Metastatic HER2-Positive Breast Cancer von Royce, Melanie, Osgood, Christy L, Amatya, Anup K, Fiero, Mallorie H, Chang, C J George, Ricks, Tiffany K, Shetty, Krithika A, Kraft, Jeffrey, Qiu, Junshan, Song, Pengfei, Charlab, Rosane, Yu, Jingyu, King, Kathryn E, Rastogi, Anshu, Janelsins, Brian, Weinberg, Wendy C, Clouse, Kathleen, Borders-Hemphill, Vicky, Brown, Lindsey, Gomez-Broughton, Candace, Li, Zhong, Nguyen, Thuy Thanh, Qiu, Zhihao, Ly, Anh-Thy, Chang, Suyoung, Gao, Tingting, Tu, Chi-Ming, King-Kallimanis, Bellinda, Pierce, William F, Chiang, Kelly, Lee, Clara, Goldberg, Kirsten B, Leighton, John K, Tang, Shenghui, Pazdur, Richard, Beaver, Julia A, Amiri-Kordestani, Laleh

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Approval Summary: Azacitidine for Treatment of Myelodysplastic Syndrome Subtypes von KAMINSKAS, Edvardas, FARRELL, Ann, WANG, Yong-Cheng, PAZDUR, Richard, ABRAHAM, Sophia, BAIRD, Amy, HSIEH, Li-Shan, LEE, Shwu-Luan, LEIGHTON, John K, PATEL, Hasmukh, RAHMAN, Atiqur, SRIDHARA, Rajeshwara

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Rules of thumb for predicting tropical forest recovery von Holl, Karen D., Reid, John Leighton, Oviedo-Brenes, Federico, Kulikowski, Andy J., Zahawi, Rakan A.

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Tasigna for Chronic and Accelerated Phase Philadelphia Chromosome–Positive Chronic Myelogenous Leukemia Resistant to or Intolerant of Imatinib von HAZARIKA, Maitreyee, XIAOPING JIANG, TIMMER, William, HARAPANHALLI, Ravi, DAGHER, Ramzi, JUSTICE, Robert, PAZDUR, Richard, QI LIU, LEE, Shwu-Luan, RAMCHANDANI, Roshni, GARNETT, Christine, ORR, Micheal S, SRIDHARA, Rajeshwari, BOOTH, Brian, LEIGHTON, John K

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Phase III Randomized Controlled Trial Comparing the Survival of Patients With Unresectable Hepatocellular Carcinoma Treated With Nolatrexed or Doxorubicin von GISH, Robert G, PORTA, Camillo, KENNEALEY, Gerard T, LAZAR, Lucian, RUFF, Paul, FELD, Ronald, CROITORU, Adina, FEUN, Lynn, JEZIORSKI, Krzysztof, LEIGHTON, John, GALLO, José

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The Effect of Diabetes on Oxaliplatin-Induced Peripheral Neuropathy von Uwah, Augusta N, Ackler, Joan, Leighton, John C, Pomerantz, Sherry, Tester, William

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Reply to colorectal carcinomas, KRAS p.G13D mutant allele–specific imbalance, and anti–epidermal growth factor receptor therapy von Woo, Janghee, Leighton, John C.

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An FDA oncology view of juvenile animal studies in support of initial pediatric trials for anticancer drugs von Leighton, John K., Saber, Haleh, Reaman, Gregory, Pazdur, Richard

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Site Preparation and Planting Strategies to Improve Native Forb Establishment in Pasturelands von Bellangue, David, Barney, Jacob, Flessner, Michael, Kubesch, Jonathan, O’Rourke, Megan, Tracy, Benjamin, Reid, John Leighton

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Approval Summary for Erlotinib for Treatment of Patients with Locally Advanced or Metastatic Non–Small Cell Lung Cancer after Failure of at Least One Prior Chemotherapy Regimen von JOHNSON, John R, COHEN, Martin, LI SHAN HSIEH, CHIDAMBARAM, Nallalerumal, ZIMMERMAN, Paul, PAZDUR, Richard, SRIDHARA, Rajeshwari, CHEN, Yeh-Fong, WILLIAMS, Gene M, DUAN, John, GOBBURU, Jogarao, BOOTH, Brian, BENSON, Kimberly, LEIGHTON, John

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An FDA analysis of clinical hold deficiencies affecting investigational new drug applications for oncology products von Manning, Michael L., Thompson, Matthew D., Saber, Haleh, Maher, Virginia E., Crich, Joyce Z., Leighton, John K.

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