Search Results - "LEIGHTON, John K"

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

“…•Investigational new drug applications for antibody-drug conjugates were interrogated.•Approaches to translating animal data to FIH dosing for ADCs are…”
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Summary of a workshop on preclinical and translational safety assessment of CD3 bispecifics by Kamperschroer, Cris, Shenton, Jacintha, Lebrec, Hervé, Leighton, John K., Moore, Paul A., Thomas, Oliver

“…Currently, there is a multitude of CD3 bispecifics with different molecular designs and binding properties in preclinical and clinical development for the…”
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An FDA oncology analysis of immune activating products and first-in-human dose selection by Saber, Haleh, Gudi, Ramadevi, Manning, Michael, Wearne, Emily, Leighton, John K.

“…As sub-therapeutic doses are not medically justifiable in patients with cancer, we retrospectively analyzed data on immune activating products, to assess…”
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Approval Summary: Azacitidine for Treatment of Myelodysplastic Syndrome Subtypes by 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

“…Purpose: This article summarizes data submitted to the U.S. Food and Drug Administration for marketing approval of azacitidine as injectable suspension…”
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Tasigna for Chronic and Accelerated Phase Philadelphia Chromosome–Positive Chronic Myelogenous Leukemia Resistant to or Intolerant of Imatinib by 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

“…Purpose: This Food and Drug Administration (FDA) approval report describes the data and analyses leading to the approval by the FDA of nilotinib (Tasigna,…”
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An FDA oncology analysis of toxicities associated with PBD-containing antibody-drug conjugates by Saber, Haleh, Simpson, Natalie, Ricks, Tiffany K., Leighton, John K.

“…With a new generation of antibody-drug conjugates (ADCs) that contain a drug-to-antibody ratio (DAR) of 2, the question remains whether advances in technology…”
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Pharmacokinetic models for first-in-human dose selection of immune-activating products in oncology by Saber, Haleh, Thompson, Matthew D., Leighton, John K.

“…Pharmacokinetic (PK) models are increasingly submitted to the FDA to support first-in-human (FIH) dose selection of immune-oncology products. To examine…”
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FDA Approval Summary: Cabozantinib for Differentiated Thyroid Cancer by 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

“…On September 17, 2021, the FDA approved cabozantinib (Cabometyx; Exelixis, Inc.) for the treatment of adult and pediatric patients 12 years of age and older…”
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An FDA oncology analysis of CD3 bispecific constructs and first-in-human dose selection by Saber, Haleh, Del Valle, Pedro, Ricks, Tiffany K., Leighton, John K.

“…We retrospectively examined the nonclinical studies conducted with 17 CD3 bispecific constructs in support of first-in-human (FIH) trials in oncology. We also…”
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FDA Approval Summary: Margetuximab plus Chemotherapy for Advanced or Metastatic HER2-Positive Breast Cancer by 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

“…On December 16, 2020, the FDA granted regular approval to margetuximab-cmkb (MARGENZA), in combination with chemotherapy, for the treatment of adult patients…”
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FDA Approval Summary: Repotrectinib for Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer by Barbato, Michael I, Bradford, Diana, Ren, Yi, Aungst, Stephanie L, Miller, Claudia P, Pan, Lili, Zirkelbach, Jeanne F, Li, Yangbing, Bi, Youwei, Fan, Jianghong, Grimstein, Manuela, Dorff, Sarah E, Amatya, Anup K, Mishra-Kalyani, Pallavi S, Scepura, Barbara, Schotland, Peter, Udoka, Opeyemi, Ojofeitimi, Idara, Leighton, John K, Rahman, Nam A, Pazdur, Richard, Singh, Harpreet, Kluetz, Paul G, Drezner, Nicole

“…On November 15, 2023, the U.S. Food and Drug Administration (FDA) granted traditional approval to repotrectinib (Augtyro, Bristol Myers Squibb Corporation) for…”
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An FDA oncology view of juvenile animal studies in support of initial pediatric trials for anticancer drugs by Leighton, John K., Saber, Haleh, Reaman, Gregory, Pazdur, Richard

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

“…A systematic analysis of new commercial investigational new drug applications (IND) submitted to the FDA's Office of Hematology and Oncology Products (OHOP) in…”
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Pharmacogenomic data submissions to the FDA: non-clinical case studies by Leighton, John K, DeGeorge, Joseph, Jacobson-Kram, David, MacGregor, James, Mendrick, Donna, Worobec, Alexandra

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Application of Emerging Technologies in Toxicology and Safety Assessment: Regulatory Perspectives by Leighton, John K.

“…Emerging technologies applied in the regulatory field encompass a group of technologies that are used in addition to or in replacement of the standard…”
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Workgroup Report: Review of Genomics Data Based on Experience with Mock Submissions: View of the CDER Pharmacology Toxicology Nonclinical Pharmacogenomics Subcommittee by Leighton, John K., Brown, Paul, Ellis, Amy, Harlow, Patricia, Harrouk, Wafa, Pine, P. Scott, Robison, Timothy, Rosario, Lilliam, Thompson, Karol

“…Over the past few years, both the U.S. Food and Drug Administration (FDA) and the pharmaceutical industry have recognized the potential importance of…”
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Isolation and sequence analysis of three cloned cDNAs for rabbit liver proteins that are related to rabbit cytochrome P-450 (form 2), the major phenobarbital-inducible form by Leighton, John K, DeBrunner-Vossbrinck, Bettina A, Kemper, Byron

“…We have isolated from rabbit liver three cDNA clones of 1400-1800 base pairs that hybridize selectively to RNA from animals treated with phenobarbital. The…”
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Characterization of rabbit cytochrome P450IIC4 cDNA and induction by phenobarbital of related hepatic mRNA levels by Zhao, J, Leighton, J K, Kemper, B

“…We have cloned cDNA containing a partial sequence of a rabbit cytochrome P-450 (designated cytochrome P450IIC4) cDNA that is a member of the cytochrome P450IIC…”
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Center for Veterinary Medicine's perspective on the beef hormone case by Leighton, J K

“…Steroidal sex hormones and synthetic derivatives are used in the US to enhance growth in food-producing animals. The European Economic Community has banned use…”
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Expression of cytochrome P450 1A1, an estrogen hydroxylase, in ovarian granulosa cells is developmentally regulated by Leighton, John K., Canning, Sandra, Guthrie, H.D., Hammond, James M.

“…In this paper we report the analysis of porcine ovarian granulosa cells for the expression of several known hepatic estrogen hydroxylase RNAs. Of the P450s…”
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