未登录FDA Approval: Ibrutinib for Patients with Previously Treated Mantle Cell Lymphoma and Previously Treated Chronic Lymphocytic Leukemia
de Claro, R. Angelo; McGinn, Karen M.; Verdun, Nicole; Lee, Shwu-Luan; Chiu, Haw-Jyh; Saber, Haleh; Brower, Margaret E.; Chang, C. J. George; Pfuma, Elimika; Habtemariam, Bahru; Bullock, Julie; Wang, Yun; Nie, Lei; Chen, Xiao-Hong; Lu, Donghao (Robert); Al-Hakim, Ali; Kane, Robert C.; Kaminskas, Edvardas; Justice, Robert; Farrell, Ann T.; Pazdur, Richard
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收藏FDA Approval: Belinostat for the Treatment of Patients with Relapsed or Refractory Peripheral T-cell Lymphoma
Lee, Hyon-Zu; Kwitkowski, Virginia E.; Del Valle, Pedro L.; Ricci, M. Stacey; Saber, Haleh; Habtemariam, Bahru A.; Bullock, Julie; Bloomquist, Erik; Shen, Yuan Li; Chen, Xiao-Hong; Brown, Janice; Mehrotra, Nitin; Dorff, Sarah; Charlab, Rosane; Kane, Robert C.; Kaminskas, Edvardas; Justice, Robert; Farrell, Ann T.; Pazdur, Richard
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收藏FDA Approval: Ceritinib for the Treatment of Metastatic Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer
Khozin, Sean; Blumenthal, Gideon M.; Zhang, Lijun; Tang, Shenghui; Brower, Margaret; Fox, Emily; Helms, Whitney; Leong, Ruby; Song, Pengfei; Pan, Yuzhuo; Liu, Qi; Zhao, Ping; Zhao, Hong; Lu, Donghao; Tang, Zhe; Al Hakim, Ali; Boyd, Karen; Keegan, Patricia; Justice, Robert; Pazdur, Richard
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收藏FDA Approval: Idelalisib Monotherapy for the Treatment of Patients with Follicular Lymphoma and Small Lymphocytic Lymphoma
Miller, Barry W.; Przepiorka, Donna; de Claro, R. Angelo; Lee, Kyung; Nie, Lei; Simpson, Natalie; Gudi, Ramadevi; Saber, Haleh; Shord, Stacy; Bullock, Julie; Marathe, Dhananjay; Mehrotra, Nitin; Hsieh, Li Shan; Ghosh, Debasis; Brown, Janice; Kane, Robert C.; Justice, Robert; Kaminskas, Edvardas; Farrell, Ann T.; Pazdur, Richard
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收藏FDA Approval: Siltuximab for the Treatment of Patients with Multicentric Castleman Disease
Deisseroth, Albert; Ko, Chia-Wen; Nie, Lei; Zirkelbach, Jeanne F.; Zhao, Liang; Bullock, Julie; Mehrotra, Nitin; Del Valle, Pedro; Saber, Haleh; Sheth, Christopher; Gehrke, Brenda; Justice, Robert; Farrell, Ann; Pazdur, Richard
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收藏FDA Approval Summary: Vemurafenib for Treatment of Unresectable or Metastatic Melanoma with the BRAFV600E Mutation
Kim, Geoffrey; Mckee, Amy E.; Ning, Yang-Min; Hazarika, Maitreyee; Theoret, Marc; Johnson, John R.; Xu, Qiang Casey; Tang, Shenghui; Sridhara, Rajeshwari; Jiang, Xiaoping; He, Kun; Roscoe, Donna; McGuinn, W. David; Helms, Whitney S.; Russell, Anne Marie; Miksinski, Sarah Pope; Zirkelbach, Jeanne Fourie; Earp, Justin; Liu, Qi; Ibrahim, Amna; Justice, Robert; Pazdur, Richard
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收藏FDA Approval: Ado-Trastuzumab Emtansine for the Treatment of Patients with HER2-Positive Metastatic Breast Cancer
Amiri-Kordestani, Laleh; Blumenthal, Gideon M.; Xu, Qiang Casey; Zhang, Lijun; Tang, Shenghui W.; Ha, Linan; Weinberg, Wendy C.; Chi, Bo; Candau-Chacon, Reyes; Hughes, Patricia; Russell, Anne M.; Miksinski, Sarah Pope; Chen, Xiao Hong; McGuinn, W. David; Palmby, Todd; Schrieber, Sarah J.; Liu, Qi; Wang, Jian; Song, Pengfei; Mehrotra, Nitin; Skarupa, Lisa; Clouse, Kathleen; Al-Hakim, Ali; Sridhara, Rajeshwari; Ibrahim, Amna; Justice, Robert; Pazdur, Richard; Cortazar, Patricia
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收藏U.S. Food and Drug Administration Approval: Obinutuzumab in Combination with Chlorambucil for the Treatment of Previously Untreated Chronic Lymphocytic Leukemia
Lee, Hyon-Zu; Miller, Barry W.; Kwitkowski, Virginia E.; Ricci, Stacey; DelValle, Pedro; Saber, Haleh; Grillo, Joseph; Bullock, Julie; Florian, Jeffry; Mehrotra, Nitin; Ko, Chia-Wen; Nie, Lei; Shapiro, Marjorie; Tolnay, Mate; Kane, Robert C.; Kaminskas, Edvardas; Justice, Robert; Farrell, Ann T.; Pazdur, Richard
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收藏Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis乳腺癌的病理完全缓解和长期临床获益: CTNeoBC汇总分析
Cortazar, Patricia; Zhang, Lijun; Untch, Michael; Mehta, Keyur; Costantino, Joseph P.; Wolmark, Norman; Bonnefoi, Herve; Cameron, David; Gianni, Luca; Valagussa, Pinuccia; Swain, Sandra M.; Prowell, Tatiana; Loibl, Sibylle; Wickerham, D. Lawrence; Bogaerts, Jan; Baselga, Jose; Perou, Charles; Blumenthal, Gideon; Blohmer, Jens; Mamounas, Eleftherios P.; Bergh, Jonas; Semiglazov, Vladimir; Justice, Robert; Eidtmann, Holger; Paik, Soonmyung; Piccart, Martine; Sridhara, Rajeshwari; Fasching, Peter A.; Slaets, Leen; Tang, Shenghui; Gerber, Bernd; Geyer, Charles E., Jr.; Pazdur, Richard; Ditsch, Nina; Rastogi, Priya; Eiermann, Wolfgang; von Minckwitz, Gunter
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收藏US Food and Drug Administration Approval: Crizotinib for Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer That Is Anaplastic Lymphoma Kinase Positive
Malik, Shakun M.; Maher, Virginia Ellen; Bijwaard, Karen E.; Becker, Robert L.; Zhang, Lijun; Tang, Shenghui W.; Song, Pengfei; Liu, Qi; Marathe, Anshu; Gehrke, Brenda; Helms, Whitney; Hanner, Diane; Justice, Robert; Pazdur, Richard
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收藏Exposure-Response Relationship of T-DM1: Insight Into Dose Optimization for Patients With HER2-Positive Metastatic Breast Cancer
Wang, J.; Song, P.; Schrieber, S.; Liu, Q.; Xu, Q.; Blumenthal, G.; Kordestani, L. Amiri; Cortazar, P.; Ibrahim, A.; Justice, R.; Wang, Y.; Tang, S.; Booth, B.; Mehrotra, N.; Rahman, A.
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收藏Radium Ra 223 Dichloride Injection: US Food and Drug Administration Drug Approval Summary
Kluetz, Paul G.; Pierce, William; Maher, V. Ellen; Zhang, Hui; Tang, Shenghui; Song, Pengfei; Liu, Qi; Haber, Martin T.; Leutzinger, Eldon E.; Al-Hakim, Ali; Chen, Wei; Palmby, Todd; Alebachew, Elleni; Sridhara, Rajeshwari; Ibrahim, Amna; Justice, Robert; Pazdur, Richard
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收藏Abiraterone Acetate in Combination with Prednisone for the Treatment of Patients with Metastatic Castration-Resistant Prostate Cancer: US Food and Drug Administration Drug Approval Summary
Kluetz, Paul G.; Ning, Yang-Min; Maher, V. Ellen; Zhang, Lijun; Tang, Shenghui; Ghosh, Debasis; Aziz, Robeena; Palmby, Todd; Pfuma, Elimika; Zirkelbach, Jeanne Fourie; Mehrotra, Nitin; Tilley, Amy; Sridhara, Rajeshwari; Ibrahim, Amna; Justice, Robert; Pazdur, Richard
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收藏A definition of a high-risk early-breast cancer population based on data from the collaborative trials in neoadjuvant breast cancer (CTNeoBC) meta-analysis
Cortazar, P.; Zhang, L.; Untch, M.; Mehta, K.; Constantino, J.; Wolmark, N.; Bonnefoi, H.; Piccart, M.; Gianni, L.; Valagussa, P.; Zujewski, J. A.; Justice, R.; Loibl, S.; Swain, S. M.; Bogaerts, J.; Baselga, J.; Prowell, T. M.; Rastogi, P.; Sridhara, R.; Tang, S.; Pazdur, R.; Mamounas, E.; von Minckwitz, G.
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收藏Pain Palliation Measurement in Cancer Clinical Trials
Basch, Ethan; Trentacosti, Ann Marie; Burke, Laurie B.; Kwitkowski, Virginia; Kane, Robert C.; Autio, Karen A.; Papadopoulos, Elektra; Stansbury, James P.; Kluetz, Paul G.; Smith, Harry; Justice, Robert; Pazdur, Richard
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收藏Enzalutamide for Treatment of Patients with Metastatic Castration-Resistant Prostate Cancer Who Have Previously Received Docetaxel: U.S. Food and Drug Administration Drug Approval Summary
Ning, Yangmin M.; Pierce, William; Maher, V. Ellen; Karuri, Stella; Tang, Sheng-Hui; Chiu, Haw-Jyh; Palmby, Todd; Zirkelbach, Jeanne Fourie; Marathe, Dhananjay; Mehrotra, Nitin; Liu, Qi; Ghosh, Debasis; Cottrell, Christy L.; Leighton, John; Sridhara, Rajeshwari; Ibrahim, Amna; Justice, Robert; Pazdur, Richard
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收藏First FDA Approval of Dual Anti-HER2 Regimen: Pertuzumab in Combination with Trastuzumab and Docetaxel for HER2-Positive Metastatic Breast Cancer
Blumenthal, Gideon M.; Scher, Nancy S.; Cortazar, Patricia; Chattopadhyay, Somesh; Tang, Shenghui; Song, Pengfei; Liu, Qi; Ringgold, Kimberly; Pilaro, Anne M.; Tilley, Amy; King, Kathryn E.; Graham, Laurie; Rellahan, Barbara L.; Weinberg, Wendy C.; Chi, Bo; Thomas, Colleen; Hughes, Patricia; Ibrahim, Amna; Justice, Robert; Pazdur, Richard
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收藏Meta-analysis Results from the Collaborative Trials in Neoadjuvant Breast Cancer (CTNeoBC)
Cortazar, P.; Zhang, L.; Untch, M.; Mehta, K.; Costantino, J.; Wolmark, N.; Bonnefoi, H.; Cameron, D.; Gianni, L.; Valagussa, P.; Zujewski, J. A.; Justice, R.; Loibl, S.; Wickerham, L.; Bogaerts, J.; Baselga, J.; Perou, C.; Blumenthal, G.; Blohmer, J.; Mamounas, E.; Bergh, J.; Semiglazov, V.; Prowell, T.; Eidtmann, H.; Paik, S.; Piccart, M.; Sridhara, R.; Fasching, P.; Swain, S. M.; Slaets, L.; Tang, S.; Gerber, B.; Geyer, C.; Pazdur, R.; Ditsch, N.; Rastogi, P.; Eiermann, W.; von Mincwitz, G.
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