FDA Approval Summary: Pertuzumab for Adjuvant Treatment of HER2-Positive Early Breast Cancer von Howie, Lynn J, Scher, Nancy S, Amiri-Kordestani, Laleh, Zhang, Lijun, King-Kallimanis, Bellinda L, Choudhry, Yasmin, Schroeder, Jason, Goldberg, Kirsten B, Kluetz, Paul G, Ibrahim, Amna, Sridhara, Rajeshwari, Blumenthal, Gideon M, Pazdur, Richard, Beaver, Julia A

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First FDA Approval of Dual Anti-HER2 Regimen: Pertuzumab in Combination with Trastuzumab and Docetaxel for HER2-Positive Metastatic Breast Cancer von BLUMENTHAL, Gideon M, SCHER, Nancy S, KING, Kathryn E, GRAHAM, Laurie, RELLAHAN, Barbara L, WEINBERG, Wendy C, BO CHI, THOMAS, Colleen, HUGHES, Patricia, IBRAHIM, Amna, JUSTICE, Robert, PAZDUR, Richard, CORTAZAR, Patricia, CHATTOPADHYAY, Somesh, SHENGHUI TANG, PENGFEI SONG, QI LIU, RINGGOLD, Kimberly, PILARO, Anne M, TILLEY, Amy

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End points to establish the efficacy of new agents in the treatment of acute leukemia von Appelbaum, Frederick R., Rosenblum, Daniel, Arceci, Robert J., Carroll, William L., Breitfeld, Philip P., Forman, Stephen J., Larson, Richard A., Lee, Stephanie J., Murphy, Sharon B., O'Brien, Susan, Radich, Jerald, Scher, Nancy S., Smith, Franklin O., Stone, Richard M., Tallman, Martin S.

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Approval Summary for Zoledronic Acid for Treatment of Multiple Myeloma and Cancer Bone Metastases von IBRAHIM, Amna, SCHER, Nancy, YUNG HSIEH, WOOD, Rebecca, VAUSE, Debra, PAZDUR, Richard, WILLIAMS, Grant, SRIDHARA, Rajeshwari, NING LI, GANG CHEN, LEIGHTON, John, BOOTH, Brian, GOBBURU, Jogarao V. S, RAHMAN, Atiqur

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U.S. Food and Drug Administration Drug Approval Summaries: Imatinib Mesylate, Mesna Tablets, and Zoledronic Acid von Cohen, Martin H., Dagher, Ramzi, Griebel, Donna J., Ibrahim, Amna, Martin, Alison, Scher, Nancy S., Sokol, Gerald H., Williams, Grant A., Pazdur, Richard

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Malignant melanoma in West Virginia von Scher, K S, Scher, N S, O'Connor, D S

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Protein Kinases in Chronic Lymphocytic Leukemia von Samuel, Edward, Chung, Chih-hua, Scher, Nancy, Rosenzweig, Barry, Silber, Robert

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Proton Beam Reirradiation for Recurrent Head and Neck Cancer: Multi-institutional Report on Feasibility and Early Outcomes von Romesser, Paul B., MD, Cahlon, Oren, MD, Scher, Eli D., DO, Hug, Eugen B., MD, Sine, Kevin, CMD, DeSelm, Carl, MD, PhD, Fox, Jana L., MD, Mah, Dennis, PhD, Garg, Madhur K., MD, Han-Chih Chang, John, MD, Lee, Nancy Y., MD

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Tumor mutational load predicts survival after immunotherapy across multiple cancer types von Samstein, Robert M., Lee, Chung-Han, Shoushtari, Alexander N., Hellmann, Matthew D., Shen, Ronglai, Janjigian, Yelena Y., Barron, David A., Zehir, Ahmet, Jordan, Emmet J., Omuro, Antonio, Kaley, Thomas J., Kendall, Sviatoslav M., Motzer, Robert J., Hakimi, A. Ari, Voss, Martin H., Russo, Paul, Rosenberg, Jonathan, Iyer, Gopa, Bochner, Bernard H., Bajorin, Dean F., Al-Ahmadie, Hikmat A., Chaft, Jamie E., Rudin, Charles M., Riely, Gregory J., Baxi, Shrujal, Ho, Alan L., Wong, Richard J., Pfister, David G., Wolchok, Jedd D., Barker, Christopher A., Gutin, Philip H., Brennan, Cameron W., Tabar, Viviane, Mellinghoff, Ingo K., DeAngelis, Lisa M., Ariyan, Charlotte E., Lee, Nancy, Tap, William D., Gounder, Mrinal M., D’Angelo, Sandra P., Saltz, Leonard, Stadler, Zsofia K., Scher, Howard I., Baselga, Jose, Razavi, Pedram, Klebanoff, Christopher A., Yaeger, Rona, Segal, Neil H., Ku, Geoffrey Y., DeMatteo, Ronald P., Ladanyi, Marc, Rizvi, Naiyer A., Berger, Michael F., Riaz, Nadeem, Solit, David B., Chan, Timothy A., Morris, Luc G. T.

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Pathogenic ATM Mutations in Cancer and a Genetic Basis for Radiotherapeutic Efficacy von Pitter, Kenneth L, Casey, Dana L, Lu, Yue C, Hannum, Margaret, Zhang, Zhigang, Song, Xinmao, Pecorari, Isabella, McMillan, Biko, Ma, Jennifer, Samstein, Robert M, Pei, Isaac X, Khan, Atif J, Braunstein, Lior Z, Morris, Luc G T, Barker, Christopher A, Rimner, Andreas, Alektiar, Kaled M, Romesser, Paul B, Crane, Christopher H, Yahalom, Joachim, Zelefsky, Michael J, Scher, Howard I, Bernstein, Jonine L, Mandelker, Diana L, Weigelt, Britta, Reis-Filho, Jorge S, Lee, Nancy Y, Powell, Simon N, Chan, Timothy A, Riaz, Nadeem, Setton, Jeremy

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Increased Survival with Enzalutamide in Prostate Cancer after Chemotherapy von Scher, Howard I, Fizazi, Karim, Saad, Fred, Taplin, Mary-Ellen, Sternberg, Cora N, Miller, Kurt, de Wit, Ronald, Mulders, Peter, Chi, Kim N, Shore, Neal D, Armstrong, Andrew J, Flaig, Thomas W, Fléchon, Aude, Mainwaring, Paul, Fleming, Mark, Hainsworth, John D, Hirmand, Mohammad, Selby, Bryan, Seely, Lynn, de Bono, Johann S

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Special Article: 2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis von Singh, Jasvinder A, Guyatt, Gordon, Ogdie, Alexis, Gladman, Dafna D, Deal, Chad, Deodhar, Atul, Dubreuil, Maureen, Dunham, Jonathan, Husni, M Elaine, Kenny, Sarah, Kwan-Morley, Jennifer, Lin, Janice, Marchetta, Paula, Mease, Philip J, Merola, Joseph F, Miner, Julie, Ritchlin, Christopher T, Siaton, Bernadette, Smith, Benjamin J, Van Voorhees, Abby S, Jonsson, Anna Helena, Shah, Amit Aakash, Sullivan, Nancy, Turgunbaev, Marat, Coates, Laura C, Gottlieb, Alice, Magrey, Marina, Nowell, W Benjamin, Orbai, Ana-Maria, Reddy, Soumya M, Scher, Jose U, Siegel, Evan, Siegel, Michael, Walsh, Jessica A, Turner, Amy S, Reston, James

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Tumour lineage shapes BRCA-mediated phenotypes von Jonsson, Philip, Bandlamudi, Chaitanya, Cheng, Michael L., Srinivasan, Preethi, Chavan, Shweta S., Friedman, Noah D., Rosen, Ezra Y., Richards, Allison L., Bouvier, Nancy, Selcuklu, S. Duygu, Bielski, Craig M., Abida, Wassim, Mandelker, Diana, Birsoy, Ozge, Zhang, Liying, Zehir, Ahmet, Donoghue, Mark T. A., Baselga, José, Offit, Kenneth, Scher, Howard I., O’Reilly, Eileen M., Stadler, Zsofia K., Schultz, Nikolaus, Socci, Nicholas D., Viale, Agnes, Ladanyi, Marc, Robson, Mark E., Hyman, David M., Berger, Michael F., Solit, David B., Taylor, Barry S.

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Special Article: 2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis von Singh, Jasvinder A, Guyatt, Gordon, Ogdie, Alexis, Gladman, Dafna D, Deal, Chad, Deodhar, Atul, Dubreuil, Maureen, Dunham, Jonathan, Husni, M Elaine, Kenny, Sarah, Kwan-Morley, Jennifer, Lin, Janice, Marchetta, Paula, Mease, Philip J, Merola, Joseph F, Miner, Julie, Ritchlin, Christopher T, Siaton, Bernadette, Smith, Benjamin J, Van Voorhees, Abby S, Jonsson, Anna Helena, Shah, Amit Aakash, Sullivan, Nancy, Turgunbaev, Marat, Coates, Laura C, Gottlieb, Alice, Magrey, Marina, Nowell, W Benjamin, Orbai, Ana-Maria, Reddy, Soumya M, Scher, Jose U, Siegel, Evan, Siegel, Michael, Walsh, Jessica A, Turner, Amy S, Reston, James

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Combined high‐intensity local treatment and systemic therapy in metastatic head and neck squamous cell carcinoma: An analysis of the National Cancer Data Base von Zumsteg, Zachary S., Luu, Michael, Yoshida, Emi J., Kim, Sungjin, Tighiouart, Mourad, David, John M., Shiao, Stephen L., Mita, Alain C., Scher, Kevin S., Sherman, Eric J., Lee, Nancy Y., Ho, Allen S.

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Considerations for the successful co-development of targeted cancer therapies and companion diagnostics von Fridlyand, Jane, Simon, Richard M., Walrath, Jessica C., Roach, Nancy, Buller, Richard, Schenkein, David P., Flaherty, Keith T., Allen, Jeff D., Sigal, Ellen V., Scher, Howard I.

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Cancer therapy shapes the fitness landscape of clonal hematopoiesis von Bolton, Kelly L., Ptashkin, Ryan N., Gao, Teng, Braunstein, Lior, Devlin, Sean M., Kelly, Daniel, Patel, Minal, Berthon, Antonin, Syed, Aijazuddin, Yabe, Mariko, Coombs, Catherine C., Caltabellotta, Nicole M., Walsh, Mike, Offit, Kenneth, Stadler, Zsofia, Mandelker, Diana, Schulman, Jessica, Patel, Akshar, Philip, John, Bernard, Elsa, Gundem, Gunes, Ossa, Juan E. Arango, Levine, Max, Martinez, Juan S. Medina, Farnoud, Noushin, Glodzik, Dominik, Li, Sonya, Robson, Mark E., Lee, Choonsik, Pharoah, Paul D. P., Stopsack, Konrad H., Spitzer, Barbara, Mantha, Simon, Fagin, James, Boucai, Laura, Gibson, Christopher J., Ebert, Benjamin L., Young, Andrew L., Druley, Todd, Takahashi, Koichi, Gillis, Nancy, Ball, Markus, Padron, Eric, Hyman, David M., Baselga, Jose, Norton, Larry, Gardos, Stuart, Klimek, Virginia M., Scher, Howard, Bajorin, Dean, Paraiso, Eder, Benayed, Ryma, Arcila, Maria E., Ladanyi, Marc, Solit, David B., Berger, Michael F., Tallman, Martin, Garcia-Closas, Montserrat, Chatterjee, Nilanjan, Diaz, Luis A., Levine, Ross L., Morton, Lindsay M., Zehir, Ahmet, Papaemmanuil, Elli

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Optimal systemic treatment and real-world clinical application of ctDNA in patients with metastatic HER2-mutant lung cancer von Liu, Si-Yang, Erazo, Tatiana, Jee, Justin, Arfe, Andrea, Gupta, Avantika, Pike, Luke R.G., Santini, Fernando C., Daly, Bobby, Schoenfeld, Adam, Eichholz, Jordan, Johnson, Kaylie, Martinez, Andres, Sui, Jane, Riaz, Nadeem, Chang, Jason, Yang, Soo-Ryum, Travis, William, Arcila, Maria E., Guo, Jiannan, Gagne, Eric, Garg, Kavita, Baehner, Frederick, Lee, Nancy Y., Drilon, Alexander, Kris, Mark G., Scher, Howard I., Razavi, Pedram, Gomez, Daniel R., Jones, David R., Rudin, Charles M., Chandarlapaty, Sarat, Isbell, James M., Li, Bob T.

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Proton beam radiation therapy results in significantly reduced toxicity compared with intensity-modulated radiation therapy for head and neck tumors that require ipsilateral radiat... von Romesser, Paul B, Cahlon, Oren, Scher, Eli, Zhou, Ying, Berry, Sean L, Rybkin, Alisa, Sine, Kevin M, Tang, Shikui, Sherman, Eric J, Wong, Richard, Lee, Nancy Y

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Metastasis-Free Survival Is a Strong Surrogate of Overall Survival in Localized Prostate Cancer von Xie, Wanling, Regan, Meredith M, Buyse, Marc, Halabi, Susan, Kantoff, Philip W, Sartor, Oliver, Soule, Howard, Clarke, Noel W, Collette, Laurence, Dignam, James J, Fizazi, Karim, Paruleker, Wendy R, Sandler, Howard M, Sydes, Matthew R, Tombal, Bertrand, Williams, Scott G, Sweeney, Christopher J

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