CDK4/6 inhibitor treatment for patients with hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer: a US Food and Drug Administration pooled analysis by Gao, Jennifer J, Cheng, Joyce, Bloomquist, Erik, Sanchez, Jacquelyn, Wedam, Suparna B, Singh, Harpreet, Amiri-Kordestani, Laleh, Ibrahim, Amna, Sridhara, Rajeshwari, Goldberg, Kirsten B, Theoret, Marc R, Kluetz, Paul G, Blumenthal, Gideon M, Pazdur, Richard, Beaver, Julia A, Prowell, Tatiana M

Get full text

FDA Approval summary: palbociclib for male patients with metastatic breast cancer by Wedam, Suparna, Fashoyin-Aje, Lola, Bloomquist, Erik, Tang, Shenghui, Sridhara, Rajeshwari, Goldberg, Kirsten B, Theoret, Marc R, Amiri-Kordestani, Laleh, Pazdur, Richard, Beaver, Julia A

Get full text

FDA Approval Summary: Olaparib Monotherapy in Patients with Deleterious Germline BRCA-Mutated Advanced Ovarian Cancer Treated with Three or More Lines of Chemotherapy by Kim, Geoffrey, Ison, Gwynn, McKee, Amy E, Zhang, Hui, Tang, Shenghui, Gwise, Thomas, Sridhara, Rajeshwari, Lee, Eunice, Tzou, Abraham, Philip, Reena, Chiu, Haw-Jyh, Ricks, Tiffany K, Palmby, Todd, Russell, Anne Marie, Ladouceur, Gaetan, Pfuma, Elimika, Li, Hongshan, Zhao, Liang, Liu, Qi, Venugopal, Rajesh, Ibrahim, Amna, Pazdur, Richard

Get full text

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 Chem... by Larkins, Erin, Blumenthal, Gideon M., Yuan, Weishi, He, Kun, Sridhara, Rajeshwari, Subramaniam, Sriram, Zhao, Hong, Liu, Chao, Yu, Jingyu, Goldberg, Kirsten B., McKee, Amy E., Keegan, Patricia, Pazdur, Richard

Get full text

FDA Approval Summary: Olaparib Monotherapy or in Combination with Bevacizumab for the Maintenance Treatment of Patients with Advanced Ovarian Cancer by Arora, Shaily, Balasubramaniam, Sanjeeve, Zhang, Hui, Berman, Tara, Narayan, Preeti, Suzman, Daniel, Bloomquist, Erik, Tang, Shenghui, Gong, Yutao, Sridhara, Rajeshwari, Turcu, Francisca Reyes, Chatterjee, Deb, Saritas‐Yildirim, Banu, Ghosh, Soma, Philip, Reena, Pathak, Anand, Gao, Jennifer J., Amiri‐Kordestani, Laleh, Pazdur, Richard, Beaver, Julia A.

Get full text

FDA Approval: Blinatumomab for Patients with B-cell Precursor Acute Lymphoblastic Leukemia in Morphologic Remission with Minimal Residual Disease by Jen, Emily Y, Xu, Qing, Schetter, Aaron, Przepiorka, Donna, Shen, Yuan Li, Roscoe, Donna, Sridhara, Rajeshwari, Deisseroth, Albert, Philip, Reena, Farrell, Ann T, Pazdur, Richard

Get full text

FDA Approval: Palbociclib for the Treatment of Postmenopausal Patients with Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer by Beaver, Julia A, Amiri-Kordestani, Laleh, Charlab, Rosane, Chen, Wei, Palmby, Todd, Tilley, Amy, Zirkelbach, Jeanne Fourie, Yu, Jingyu, Liu, Qi, Zhao, Liang, Crich, Joyce, Chen, Xiao Hong, Hughes, Minerva, Bloomquist, Erik, Tang, Shenghui, Sridhara, Rajeshwari, Kluetz, Paul G, Kim, Geoffrey, Ibrahim, Amna, Pazdur, Richard, Cortazar, Patricia

Get full text

FDA Approval Summary: Atezolizumab or Pembrolizumab for the Treatment of Patients with Advanced Urothelial Carcinoma Ineligible for Cisplatin‐Containing Chemotherapy by Suzman, Daniel L., Agrawal, Sundeep, Ning, Yang‐min, Maher, V. Ellen, Fernandes, Laura L., Karuri, Stella, Tang, Shenghui, Sridhara, Rajeshwari, Schroeder, Jason, Goldberg, Kirsten B., Ibrahim, Amna, McKee, Amy E., Pazdur, Richard, Beaver, Julia A.

Get full text

FDA Approval Summary: Nivolumab in Advanced Renal Cell Carcinoma After Anti‐Angiogenic Therapy and Exploratory Predictive Biomarker Analysis by Xu, James Xunhai, Maher, V. Ellen, Zhang, Lijun, Tang, Shenghui, Sridhara, Rajeshwari, Ibrahim, Amna, Kim, Geoffrey, Pazdur, Richard

Get full text

FDA Approval Summary: Atezolizumab Plus Paclitaxel Protein-bound for the Treatment of Patients with Advanced or Metastatic TNBC Whose Tumors Express PD-L1 by Narayan, Preeti, Wahby, Sakar, Gao, Jennifer J, Amiri-Kordestani, Laleh, Ibrahim, Amna, Bloomquist, Erik, Tang, Shenghui, Xu, Yuan, Liu, Jiang, Fu, Wentao, Song, Pengfei, King-Kallimanis, Bellinda L, Hou, Sherry, Gong, Yutao, Kalavar, Shyam, Ghosh, Soma, Philip, Reena, Goldberg, Kirsten B, Theoret, Marc R, Blumenthal, Gideon M, Kluetz, Paul G, Sridhara, Rajeshwari, Pazdur, Richard, Beaver, Julia A

Get full text

Differentiation Syndrome with Ivosidenib and Enasidenib Treatment in Patients with Relapsed or Refractory IDH-Mutated AML: A U.S. Food and Drug Administration Systematic Analysis by Norsworthy, Kelly J, Mulkey, Flora, Scott, Emma C, Ward, Ashley F, Przepiorka, Donna, Charlab, Rosane, Dorff, Sarah E, Deisseroth, Albert, Kazandjian, Dickran, Sridhara, Rajeshwari, Beaver, Julia A, Farrell, Ann T, de Claro, R Angelo, Pazdur, Richard

Get full text

Patients with melanoma treated with an anti-PD-1 antibody beyond RECIST progression: a US Food and Drug Administration pooled analysis by Beaver, Julia A, Hazarika, Maitreyee, Mulkey, Flora, Mushti, Sirisha, Chen, Huanyu, He, Kun, Sridhara, Rajeshwari, Goldberg, Kirsten B, Chuk, Meredith K, Chi, Dow-Chung, Chang, Jennie, Barone, Amy, Balasubramaniam, Sanjeeve, Blumenthal, Gideon M, Keegan, Patricia, Pazdur, Richard, Theoret, Marc R

Get full text

Reflections and Roadmaps: Career Development Beyond the FDA-AACR Oncology Educational Fellowship by Patel, Timil, Chen, Chris, Al Hadidi, Samer, Kadry, Yasmin, Sridhara, Rajeshwari, Purcell, Erin, Wisch, Laura, Retzlaff, Jon, Foti, Margaret, Pazdur, Richard, Kluetz, Paul, Gao, Jennifer

Get full text

Letrozole in the Extended Adjuvant Treatment of Postmenopausal Women with History of Early-Stage Breast Cancer Who Have Completed 5 Years of Adjuvant Tamoxifen by MANN, Bhupinder S, JOHNSON, John R, KELLY, Roswitha, SRIDHARA, Rajeshwari, WILLIAMS, Grant, PAZDUR, Richard

Get full text

FDA Approval: Ado-Trastuzumab Emtansine for the Treatment of Patients with HER2-Positive Metastatic Breast Cancer by AMIRI-KORDESTANI, Laleh, BLUMENTHAL, Gideon M, RUSSELL, Anne M, MIKSINSKI, Sarah Pope, XIAO HONG CHEN, McGUINN, W. David, PALMBY, Todd, SCHRIEBER, Sarah J, QI LIU, JIAN WANG, PENGFEI SONG, MEHROTRA, Nitin, QIANG CASEY XU, SKARUPA, Lisa, CLOUSE, Kathleen, AL-HAKIM, Ali, SRIDHARA, Rajeshwari, IBRAHIM, Amna, JUSTICE, Robert, PAZDUR, Richard, CORTAZAR, Patricia, LIJUN ZHANG, TANG, Shenghui W, LINAN HA, WEINBERG, Wendy C, BO CHI, CANDAU-CHACON, Reyes, HUGHES, Patricia

Get full text

FDA Approval of Palbociclib in Combination with Fulvestrant for the Treatment of Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer by Walker, Amanda J, Wedam, Suparna, Amiri-Kordestani, Laleh, Bloomquist, Erik, Tang, Shengui, Sridhara, Rajeshwari, Chen, Wei, Palmby, Todd R, Fourie Zirkelbach, Jeanne, Fu, Wentao, Liu, Qi, Tilley, Amy, Kim, Geoffrey, Kluetz, Paul G, McKee, Amy E, Pazdur, Richard

Get full text

FDA approval summary: vemurafenib for treatment of unresectable or metastatic melanoma with the BRAFV600E mutation by 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

Get full text

US Food and Drug Administration review of statistical analysis of patient-reported outcomes in lung cancer clinical trials approved between January, 2008, and December, 2017 by Fiero, Mallorie H, Roydhouse, Jessica K, Vallejo, Jonathon, King-Kallimanis, Bellinda L, Kluetz, Paul G, Sridhara, Rajeshwari

Get full text

FDA Approval Summary: Pertuzumab for Adjuvant Treatment of HER2-Positive Early Breast Cancer by 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

Get full text

A Bayesian approach in design and analysis of pediatric cancer clinical trials by Ye, Jingjing, Reaman, Gregory, De Claro, R. Angelo, Sridhara, Rajeshwari

Get full text