Search Results - "ZIRKELBACH, Jeanne Fourie"

Use of patient-reported outcomes (PRO) data to complement exposure–response analysis in early clinical cancer drug development by Xia, Huiming, Booth, Brian P., Wang, Yaning, Fan, Chunling, Bhatnagar, Vishal, Kluetz, Paul, Fourie Zirkelbach, Jeanne

“…Background This proof-of-concept retrospective case study investigated whether patient-reported outcomes (PRO) instruments, designed to capture symptomatic…”
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Improving Dose-Optimization Processes Used in Oncology Drug Development to Minimize Toxicity and Maximize Benefit to Patients by Fourie Zirkelbach, Jeanne, Shah, Mirat, Vallejo, Jonathon, Cheng, Joyce, Ayyoub, Amal, Liu, Jiang, Hudson, Rachel, Sridhara, Rajeshwari, Ison, Gwynn, Amiri-Kordestani, Laleh, Tang, Shenghui, Gwise, Thomas, Rahman, Atiqur, Pazdur, Richard, Theoret, Marc R.

“…This review highlights strategies to integrate dose optimization into premarketing drug development and discusses the underlying statistical principles. Poor…”
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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

“…On February 19, 2016, the FDA approved palbociclib (Ibrance, Pfizer) for use in combination with fulvestrant (Faslodex, AstraZeneca) for the treatment of women…”
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FDA Approval Summary: Pembrolizumab, Atezolizumab, and Cemiplimab-rwlc as Single Agents for First-Line Treatment of Advanced/Metastatic PD-L1-High NSCLC by Akinboro, Oladimeji, Larkins, Erin, Pai-Scherf, Lee H, Mathieu, Luckson N, Ren, Yi, Cheng, Joyce, Fiero, Mallorie H, Fu, Wentao, Bi, Youwei, Kalavar, Shyam, Jafri, Samina, Mishra-Kalyani, Pallavi S, Fourie Zirkelbach, Jeanne, Li, Hongshan, Zhao, Hong, He, Kun, Helms, Whitney S, Chuk, Meredith K, Wang, Min, Bulatao, Ilynn, Herz, Jonathan, Osborn, Blaire L, Xu, Yuan, Liu, Jiang, Gong, Yutao, Sickafuse, Sharon, Cohen, Rebecca, Donoghue, Martha, Pazdur, Richard, Beaver, Julia A, Singh, Harpreet

“…FDA's approval of cemiplimab-rwlc on February 22, 2021, follows prior approvals of pembrolizumab and atezolizumab for similar indications as first-line…”
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FDA Approval Summary: Tivozanib for Relapsed or Refractory Renal Cell Carcinoma by Chang, Elaine, Weinstock, Chana, Zhang, Lijun, Fiero, Mallorie H, Zhao, Miao, Zahalka, Eias, Ricks, Tiffany K, Fourie Zirkelbach, Jeanne, Qiu, Junshan, Yu, Jingyu, Chen, Xiao Hong, Bhatnagar, Vishal, Goldberg, Kirsten B, Tang, Shenghui, Kluetz, Paul G, Pazdur, Richard, Ibrahim, Amna, Beaver, Julia A, Amiri-Kordestani, Laleh

“…On March 10, 2021, the FDA granted regular approval to tivozanib for treatment of patients with relapsed or refractory (R/R) advanced renal cell carcinoma…”
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FDA Approval Summary: Pemigatinib for Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma with FGFR2 Fusion or Other Rearrangement by Patel, Timil H, Marcus, Leigh, Horiba, M Naomi, Donoghue, Martha, Chatterjee, Somak, Mishra-Kalyani, Pallavi S, Schuck, Robert N, Li, Yangbing, Zhang, Xinyuan, Fourie Zirkelbach, Jeanne, Charlab, Rosane, Liu, Jiang, Yang, Yuching, Lemery, Steven J, Pazdur, Richard, Theoret, Marc R, Fashoyin-Aje, Lola A

“…On April 17, 2020, the FDA granted accelerated approval to pemigatinib (PEMAZYRE, Incyte Corporation) for the treatment of adults with previously treated,…”
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FDA Approval Summary: Pembrolizumab for the Treatment of Patients with Unresectable or Metastatic Melanoma by Barone, Amy, Hazarika, Maitreyee, Theoret, Marc R, Mishra-Kalyani, Pallavi, Chen, Huanyu, He, Kun, Sridhara, Rajeshwari, Subramaniam, Sriram, Pfuma, Elimika, Wang, Yaning, Li, Hongshan, Zhao, Hong, Zirkelbach, Jeanne Fourie, Keegan, Patricia, Pazdur, Richard

“…On December 18, 2015, the FDA granted regular approval to pembrolizumab (KEYTRUDA; Merck Sharp & Dohme Corp.) for treatment of patients with unresectable or…”
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FDA Approval Summary: Selpercatinib for the treatment of advanced RET fusion-positive solid tumors by Duke, Elizabeth S, Bradford, Diana, Marcovitz, Michelle, Amatya, Anup K, Mishra-Kalyani, Pallavi S, Nguyen, Emily, Price, Lauren S L, Fourie Zirkelbach, Jeanne, Li, Yangbing, Bi, Youwei, Kraft, Jeffrey, Dorff, Sarah E, Scepura, Barbara, Stephenson, Maritsa, Ojofeitimi, Idara, Nair, Abhilasha, Han, Yu, Tezak, Zivana, Lemery, Steven J, Pazdur, Richard, Larkins, Erin, Singh, Harpreet

“…On September 21, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to selpercatinib (Retevmo®, Eli Lilly and Company) for the…”
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FDA Approval Summary: Selpercatinib for the Treatment of Advanced RET Fusion-Positive Solid Tumors by Duke, Elizabeth S, Bradford, Diana, Marcovitz, Michelle, Amatya, Anup K, Mishra-Kalyani, Pallavi S, Nguyen, Emily, Price, Lauren S L, Fourie Zirkelbach, Jeanne, Li, Yangbing, Bi, Youwei, Kraft, Jeffrey, Dorff, Sarah E, Scepura, Barbara, Stephenson, Maritsa, Ojofeitimi, Idara, Nair, Abhilasha, Han, Yu, Tezak, Zivana, Lemery, Steven J, Pazdur, Richard, Larkins, Erin, Singh, Harpreet

“…On September 21, 2022, the FDA granted accelerated approval to selpercatinib (Retevmo, Eli Lilly and Company) for the treatment of adult patients with locally…”
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Use of Partial AUC (PAUC) to Evaluate Bioequivalence—A Case Study with Complex Absorption: Methylphenidate by Fourie Zirkelbach, Jeanne, Jackson, Andre J., Wang, Yaning, Schuirmann, Donald J.

“…ABSTRACT Purpose Methylphenidate modified-release products produce early and late peak concentrations critical for treatment of morning and afternoon symptoms…”
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Bioequivalence of long half-life drugs--informative sampling determination--using truncated area in parallel-designed studies for slow sustained-release formulations by El-Tahtawy, Ahmed, Harrison, Ferrin, Zirkelbach, Jeanne Fourie, Jackson, Andre J

“…A simulation study was done to determine if 72 h is the most informative sampling duration for bioequivalence (BE) determination in parallel-designed BE…”
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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

“…On February 3, 2015, the FDA granted accelerated approval to palbociclib (IBRANCE, Pfizer Inc.), an inhibitor of cyclin-dependent kinases 4 and 6 (CDK4 and…”
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US Food and Drug Administration Approval Summary: Nivolumab Plus Platinum-Doublet Chemotherapy for the Neoadjuvant Treatment of Patients With Resectable Non-Small-Cell Lung Cancer by Akinboro, Oladimeji, Drezner, Nicole, Amatya, Anup, Runyan, Jin, Fourie-Zirkelbach, Jeanne, Zhao, Miao, Bi, Youwei, Korsah, Kwadwo, Mixter, Bronwyn, Tang, Shenghui, Larkins, Erin, Pazdur, Richard, Beaver, Julia A, Singh, Harpreet

“…On March 4, 2022, the US Food and Drug Administration (FDA) approved nivolumab plus platinum-doublet chemotherapy for the neoadjuvant treatment of patients…”
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FDA Approval Summary: Selpercatinib for the Treatment of Lung and Thyroid Cancers with RET Gene Mutations or Fusions by Bradford, Diana, Larkins, Erin, Mushti, Sirisha L, Rodriguez, Lisa, Skinner, Amy M, Helms, Whitney S, Price, Lauren S L, Zirkelbach, Jeanne Fourie, Li, Yangbing, Liu, Jiang, Charlab, Rosane, Turcu, Francisca Reyes, Liang, Dun, Ghosh, Soma, Roscoe, Donna, Philip, Reena, Zack-Taylor, Autumn, Tang, Shenghui, Kluetz, Paul G, Beaver, Julia A, Pazdur, Richard, Theoret, Marc R, Singh, Harpreet

“…On May 8, 2020, the FDA granted accelerated approval to selpercatinib for (i) adult patients with metastatic fusion-positive non-small cell lung cancer…”
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FDA Approval Summary: Capmatinib and Tepotinib for the Treatment of Metastatic NSCLC Harboring MET Exon 14 Skipping Mutations or Alterations by Mathieu, Luckson N, Larkins, Erin, Akinboro, Oladimeji, Roy, Pourab, Amatya, Anup K, Fiero, Mallorie H, Mishra-Kalyani, Pallavi S, Helms, Whitney S, Myers, Claire E, Skinner, Amy M, Aungst, Stephanie, Jin, Runyan, Zhao, Hong, Xia, Huiming, Zirkelbach, Jeanne Fourie, Bi, Youwei, Li, Yangbing, Liu, Jiang, Grimstein, Manuela, Zhang, Xinyuan, Woods, Stacie, Reece, Kelie, Abukhdeir, Abdelrahmman M, Ghosh, Soma, Philip, Reena, Tang, Shenghui, Goldberg, Kirsten B, Pazdur, Richard, Beaver, Julia A, Singh, Harpreet

“…The FDA approved capmatinib and tepotinib on May 6, 2020, and February 3, 2021, respectively. Capmatinib is indicated for patients with metastatic non-small…”
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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

“…On August 17, 2011, the U.S. Food and Drug Administration (FDA) approved vemurafenib tablets (Zelboraf, Hoffmann-LaRoche Inc.) for the treatment of patients…”
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FDA Approval Summary: Osimertinib for Adjuvant Treatment of Surgically Resected Non-Small Cell Lung Cancer, a Collaborative Project Orbis Review by Koch, Abigail L, Vellanki, Paz J, Drezner, Nicole, Li, Xiaoxue, Mishra-Kalyani, Pallavi S, Shen, Yuan Li, Xia, Huiming, Li, Yangbing, Liu, Jiang, Zirkelbach, Jeanne Fourie, Palazov, Elitza, Gamarian, Aleksandr, Choo, Qiuyi, Girčys, Arūnas, Rohr, Ulrich-Peter, Fesenko, Nataliya, Spillman, Dianne, Pazdur, Richard, Beaver, Julia A, Singh, Harpreet

“…On December 18, 2020, the FDA approved osimertinib as adjuvant therapy in patients with non-small cell lung cancer (NSCLC) whose tumors have EGFR exon 19…”
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FDA Approval Summary: Capecitabine Labeling Update under Project Renewal by Agrawal, Sundeep, Lee, Clara, Pierce, William F, Everhart, Elizabeth, King-Ducre, Adriene, Royce, Melanie, Osgood, Christy L, Amiri-Kordestani, Laleh, Chiu, Haw-Jyh, Ricks, Tiffany K, Pan, Lili, Fourie Zirkelbach, Jeanne, Charlab, Rosane, Pacanowski, Michael, Kim, Tamy, Pazdur, Richard, Kluetz, Paul G, Gao, Jennifer J

“…On December 14, 2022, the U.S. Food and Drug Administration (FDA) approved revisions to the United States Prescribing Information (USPI) for capecitabine that…”
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FDA Approval Summary: Mobocertinib for Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations by Duke, Elizabeth S, Stapleford, Liza, Drezner, Nicole, Amatya, Anup K, Mishra-Kalyani, Pallavi S, Shen, Yuan-Li, Maxfield, Kimberly, Zirkelbach, Jeanne Fourie, Bi, Youwei, Liu, Jiang, Zhang, Xinyuan, Wang, Hezhen, Yang, Yuching, Zheng, Nan, Reece, Kelie, Wearne, Emily, Glen, Jacqueline J, Ojofeitimi, Idara, Scepura, Barbara, Nair, Abhilasha, Bikkavilli, Rama Kamesh, Ghosh, Soma, Philip, Reena, Pazdur, Richard, Beaver, Julia A, Singh, Harpreet, Donoghue, Martha

“…On September 15, 2021, the FDA granted accelerated approval to mobocertinib (Exkivity, Takeda Pharmaceuticals USA, Inc.) for the treatment of adult patients…”
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Exploration of PRO-CTCAE Data Used for Exposure-Response Relationships in an Oncology Clinical Trial by Xia, Huiming, Fourie, Jeanne Zirkelbach, Booth, Brian, Wang, Yaning, Fiero, Mallorie H., Przepiorka, Donna, Kluetz, Paul

“…Background: Exposure-response (ER) analysis is used in oncology clinical trials to characterize the relationship between drug exposure and safety outcomes…”
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