U.S. Food and Drug Administration Approval Summary: Brentuximab Vedotin for the Treatment of Relapsed Hodgkin Lymphoma or Relapsed Systemic Anaplastic Large-Cell Lymphoma
DE CLARO, R. Angelo, MCGINN, Karen, ROTHMANN, Mark, SHAPIRO, Marjorie, BORREGO, Francisco, CLOUSE, Kathleen, XIAO HONG CHEN, BROWN, Janice, AKINSANYA, Lara, KANE, Robert, KAMINSKAS, Edvardas, FARRELL, Ann, KWITKOWSKI, Virginia, PAZDUR, Richard, BULLOCK, Julie, KHANDELWAL, Aakanksha, HABTEMARIAM, Bahru, OUYANG, Yanli, SABER, Haleh, LEE, Kyung, KOTI, Kallappa
Published in Clinical cancer research (01.11.2012)
Published in Clinical cancer research (01.11.2012)
Get full text
Journal Article
Sorafenib for the Treatment of Advanced Renal Cell Carcinoma
KANE, Robert C, FARRELL, Ann T, SRIDHARA, Rajeshwari, GARVEY, Patricia, JUSTICE, Robert, PAZDUR, Richard, SABER, Haleh, SHENGHUI TANG, WILLIAMS, Gene, JEE, Josephine M, CHENGYI LIANG, BOOTH, Brian, CHIDAMBARAM, Nallaperumal, MORSE, David
Published in Clinical cancer research (15.12.2006)
Published in Clinical cancer research (15.12.2006)
Get full text
Journal Article
Sprycel for Chronic Myeloid Leukemia and Philadelphia Chromosome–Positive Acute Lymphoblastic Leukemia Resistant to or Intolerant of Imatinib Mesylate
BRAVE, Michael, GOODMAN, Vicki, MEN, Angela, NOORY, Carol, RAMCHANDANI, Roshni, KENNA, Leslie, BOOTH, Brian, GOBBURU, Joga, XIAOPING JIANG, SRIDHARA, Rajeshwari, JUSTICE, Robert, PAZDUR, Richard, KAMINSKAS, Edvardas, FARRELL, Ann, TIMMER, William, POPE, Sarah, HARAPANHALLI, Ravi, SABER, Haleh, MORSE, David, BULLOCK, Julie
Published in Clinical cancer research (15.01.2008)
Published in Clinical cancer research (15.01.2008)
Get full text
Journal Article
U.S. Food and Drug Administration Approval Summary: Omacetaxine Mepesuccinate as Treatment for Chronic Myeloid Leukemia
Alvandi, Firoozeh, Kwitkowski, Virginia E., Ko, Chia‐Wen, Rothmann, Mark D., Ricci, Stacey, Saber, Haleh, Ghosh, Debasis, Brown, Janice, Pfeiler, Erika, Chikhale, Elsbeth, Grillo, Joseph, Bullock, Julie, Kane, Robert, Kaminskas, Edvardas, Farrell, Ann T., Pazdur, Richard
Published in The oncologist (Dayton, Ohio) (01.01.2014)
Published in The oncologist (Dayton, Ohio) (01.01.2014)
Get full text
Journal Article
Clinical Development of Cancer Drugs in Combination With External Beam Radiation Therapy: US Food and Drug Administration Perspective
Walker, Amanda J., MD, Kim, Hyun, MD, Saber, Haleh, PhD, Kluetz, Paul G., MD, Kim, Geoffrey, MD, Pazdur, Richard, MD
Published in International journal of radiation oncology, biology, physics (01.05.2017)
Published in International journal of radiation oncology, biology, physics (01.05.2017)
Get full text
Journal Article
Trends in the approval of cancer therapies by the FDA in the twenty-first century
Scott, Emma C, Baines, Andrea C, Gong, Yutao, Moore, Jr, Rodney, Pamuk, Gulsum E, Saber, Haleh, Subedee, Ashim, Thompson, Matthew D, Xiao, Wenming, Pazdur, Richard, Rao, V Ashutosh, Schneider, Julie, Beaver, Julia A
Published in Nature reviews. Drug discovery (01.08.2023)
Published in Nature reviews. Drug discovery (01.08.2023)
Get full text
Journal Article
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, Li Shen, Yuan, Chen, Xiao-Hong, Brown, Janice, Mehrotra, Nitin, Dorff, Sarah, Charlab, Rosane, Kane, Robert C, Kaminskas, Edvardas, Justice, Robert, Farrell, Ann T, Pazdur, Richard
Published in Clinical cancer research (15.06.2015)
Published in Clinical cancer research (15.06.2015)
Get full text
Journal Article
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
Published in Clinical cancer research (01.04.2015)
Published in Clinical cancer research (01.04.2015)
Get full text
Journal Article
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
Published in Clinical cancer research (01.03.2015)
Published in Clinical cancer research (01.03.2015)
Get full text
Journal Article
An FDA oncology analysis of CD3 bispecific constructs and first-in-human dose selection
Saber, Haleh, Del Valle, Pedro, Ricks, Tiffany K., Leighton, John K.
Published in Regulatory toxicology and pharmacology (01.11.2017)
Published in Regulatory toxicology and pharmacology (01.11.2017)
Get full text
Journal Article
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
Published in Clinical cancer research (15.08.2015)
Published in Clinical cancer research (15.08.2015)
Get full text
Journal Article
Measuring ovarian toxicity in clinical trials: an American Society of Clinical Oncology research statement
Cui, Wanda, Rocconi, Rodney P, Thota, Ramya, Anderson, Richard A, Bruinooge, Suanna S, Comstock, Ioanna A, Denduluri, Neelima, Gassman, Audrey, Gralow, Julie, Hutt, Karla J, Amiri-Kordestani, Laleh, Lambertini, Matteo, Leighton, John, Lu, Karen H, Mostoufi-Moab, Sogol, Pollastro, Teri, Pradhan, Shan, Saber, Haleh, Schenkel, Caroline, Spratt, Daniel, Wedam, Suparna, Phillips, Kelly-Anne
Published in The lancet oncology (01.10.2023)
Published in The lancet oncology (01.10.2023)
Get full text
Journal Article
U.S. Food and Drug Administration Approval: Ruxolitinib for the Treatment of Patients with Intermediate and High-Risk Myelofibrosis
DEISSEROTH, Albert, KAMINSKAS, Edvardas, BULLOCK, Julie, BURKE, Laurie B, RAHMAN, Atiqur, SRIDHARA, Rajeshwari, FARRELL, Ann, PAZDUR, Richard, GRILLO, Joseph, WEI CHEN, SABER, Haleh, LU, Hong L, ROTHMANN, Mark D, BRAR, Satjit, JIAN WANG, GARNETT, Christine
Published in Clinical cancer research (15.06.2012)
Published in Clinical cancer research (15.06.2012)
Get full text
Journal Article
An FDA analysis of clinical hold deficiencies affecting investigational new drug applications for oncology products
Manning, Michael L., Thompson, Matthew D., Saber, Haleh, Maher, Virginia E., Crich, Joyce Z., Leighton, John K.
Published in Regulatory toxicology and pharmacology (01.02.2020)
Published in Regulatory toxicology and pharmacology (01.02.2020)
Get full text
Journal Article
FDA Review Summary: Mozobil in Combination with Granulocyte Colony-Stimulating Factor to Mobilize Hematopoietic Stem Cells to the Peripheral Blood for Collection and Subsequent Autologous Transplantation
Brave, Michael, Farrell, Ann, Ching Lin, Sue, Ocheltree, Terrance, Pope Miksinski, Sarah, Lee, Shwu-Luan, Saber, Haleh, Fourie, Jeanne, Tornoe, Christoffer, Booth, Brian, Yuan, Weishi, He, Kun, Justice, Robert, Pazdur, Richard
Published in Oncology (01.01.2010)
Published in Oncology (01.01.2010)
Get full text
Journal Article