FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non‐Small Cell Lung Cancer: First‐Line Therapy and Beyond
Pai‐Scherf, Lee, Blumenthal, Gideon M., Li, Hongshan, Subramaniam, Sriram, Mishra‐Kalyani, Pallavi S., He, Kun, Zhao, Hong, Yu, Jingyu, Paciga, Mark, Goldberg, Kirsten B., McKee, Amy E., Keegan, Patricia, Pazdur, Richard
Published in The oncologist (Dayton, Ohio) (01.11.2017)
Published in The oncologist (Dayton, Ohio) (01.11.2017)
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Journal Article
FDA Approval Summary: Sotorasib for KRAS G12C-Mutated Metastatic NSCLC
Nakajima, Erica C, Drezner, Nicole, Li, Xiaoxue, Mishra-Kalyani, Pallavi S, Liu, Yajun, Zhao, Hong, Bi, Youwei, Liu, Jiang, Rahman, Atiqur, Wearne, Emily, Ojofeitimi, Idara, Hotaki, Lauren Tesh, Spillman, Dianne, Pazdur, Richard, Beaver, Julia A, Singh, Harpreet
Published in Clinical cancer research (14.04.2022)
Published in Clinical cancer research (14.04.2022)
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The Association Between Baseline Hepatic or Renal Function and Clinical Outcomes for Patients With Non-Small Cell Lung Cancer Treated With a PD-1/PD-L1 Blocking Antibody Using Real-World and Trial Data
Liu, Qi, Mathur, Raina, Xu, Yuan, Torres, Aracelis Z, Miksad, Rebecca A, Liu, Chao, Smithson, Haixia, Wang, Yaning, Zhu, Hao, Booth, Brian, Huang, Shiew-Mei, Zhi, Jizu, Sridhara, Rajeshwari, Blumenthal, Gideon Michael, Larkins, Erin, Mishra-Kalyani, Pallavi S, Rivera, Donna R, Kluetz, Paul G, Sharon, Elad
Published in Clinical pharmacology and therapeutics (01.05.2023)
Published in Clinical pharmacology and therapeutics (01.05.2023)
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Journal Article
FDA Accelerated Approval of Pembrolizumab for Recurrent Locally Advanced or Metastatic Merkel Cell Carcinoma
Bradford, Diana, Demko, Suzanne, Jin, Susan, Mishra‐Kalyani, Pallavi, Beckles, Aaliyah R., Goldberg, Kirsten B., Lemery, Steven, Ward, Ashley, Keegan, Patricia, Pazdur, Richard
Published in The oncologist (Dayton, Ohio) (01.07.2020)
Published in The oncologist (Dayton, Ohio) (01.07.2020)
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Analyzing patient‐reported outcome data when completion differs between arms in open‐label trials: an application of principal stratification
Roydhouse, Jessica K., Gutman, Roee, Bhatnagar, Vishal, Kluetz, Paul G., Sridhara, Rajeshwari, Mishra‐Kalyani, Pallavi S.
Published in Pharmacoepidemiology and drug safety (01.10.2019)
Published in Pharmacoepidemiology and drug safety (01.10.2019)
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Journal Article
The Friends of Cancer Research Real‐World Data Collaboration Pilot 2.0: Methodological Recommendations from Oncology Case Studies
Rivera, Donna R., Henk, Henry J., Garrett‐Mayer, Elizabeth, Christian, Jennifer B., Belli, Andrew J., Bruinooge, Suanna S., Espirito, Janet L., Sweetnam, Connor, Izano, Monika A., Natanzon, Yanina, Robert, Nicholas J., Walker, Mark S., Cohen, Aaron B., Boyd, Marley, Enewold, Lindsey, Hansen, Eric, Honnold, Rebecca, Kushi, Lawrence, Mishra Kalyani, Pallavi S., Pe Benito, Ruth, Sakoda, Lori C., Sharon, Elad, Tymejczyk, Olga, Valice, Emily, Wagner, Joseph, Lasiter, Laura, Allen, Jeff D.
Published in Clinical pharmacology and therapeutics (01.01.2022)
Published in Clinical pharmacology and therapeutics (01.01.2022)
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Journal Article
FDA Approval Summary: Atezolizumab and Durvalumab in Combination with Platinum‐Based Chemotherapy in Extensive Stage Small Cell Lung Cancer
Mathieu, Luckson, Shah, Sujay, Pai‐Scherf, Lee, Larkins, Erin, Vallejo, Jonathon, Li, Xiaoxue, Rodriguez, Lisa, Mishra‐Kalyani, Pallavi, Goldberg, Kirsten B., Kluetz, Paul G., Theoret, Marc R., Beaver, Julia A., Pazdur, Richard, Singh, Harpreet
Published in The oncologist (Dayton, Ohio) (01.05.2021)
Published in The oncologist (Dayton, Ohio) (01.05.2021)
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Journal Article
FDA Approval Summary: Pralsetinib for the Treatment of Lung and Thyroid Cancers With RET Gene Mutations or Fusions
Kim, Janice, Bradford, Diana, Larkins, Erin, Pai-Scherf, Lee H, Chatterjee, Somak, Mishra-Kalyani, Pallavi S, Wearne, Emily, Helms, Whitney S, Ayyoub, Amal, Bi, Youwei, Sun, Jielin, Charlab, Rosane, Liu, Jiang, Zhao, Hong, Liang, Dun, Ghosh, Soma, Philip, Reena, Pazdur, Richard, Theoret, Marc R, Beaver, Julia A, Singh, Harpreet
Published in Clinical cancer research (15.10.2021)
Published in Clinical cancer research (15.10.2021)
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Journal Article
FDA Approval Summary: Capmatinib and Tepotinib for the Treatment of Metastatic NSCLC Harboring MET Exon 14 Skipping Mutations or Alterations
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
Published in Clinical cancer research (15.01.2022)
Published in Clinical cancer research (15.01.2022)
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Journal Article
FDA Approval Summary: Amivantamab for the Treatment of Patients with Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
Chon, Katie, Larkins, Erin, Chatterjee, Somak, Mishra-Kalyani, Pallavi S, Aungst, Stephanie, Wearne, Emily, Subramaniam, Sriram, Li, Yangbing, Liu, Jiang, Sun, Jielin, Charlab, Rosane, Zhao, Hong, Saritas-Yildirim, Banu, Bikkavilli, Rama Kamesh, Ghosh, Soma, Philip, Reena, Beaver, Julia A, Singh, Harpreet
Published in Clinical cancer research (01.09.2023)
Published in Clinical cancer research (01.09.2023)
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Journal Article
FDA Approval Summary: Osimertinib for Adjuvant Treatment of Surgically Resected Non-Small Cell Lung Cancer, a Collaborative Project Orbis Review
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
Published in Clinical cancer research (15.12.2021)
Published in Clinical cancer research (15.12.2021)
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Journal Article
FDA Approval Summary: Nivolumab in Combination with Ipilimumab for the Treatment of Unresectable Malignant Pleural Mesothelioma
Nakajima, Erica C, Vellanki, Paz J, Larkins, Erin, Chatterjee, Somak, Mishra-Kalyani, Pallavi S, Bi, Youwei, Qosa, Hisham, Liu, Jiang, Zhao, Hong, Biable, Missiratch, Hotaki, Lauren Tesh, Shen, Yuan-Li, Pazdur, Richard, Beaver, Julia A, Singh, Harpreet, Donoghue, Martha
Published in Clinical cancer research (01.02.2022)
Published in Clinical cancer research (01.02.2022)
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Journal Article
Correlations of response rate and progression-free survival with overall survival in immunotherapy trials for metastatic non-small-cell lung cancer: an FDA pooled analysis
Goulart, Bernardo Haddock Lobo, Mushti, Sirisha L, Chatterjee, Somak, Larkins, Erin, Mishra-Kalyani, Pallavi S, Pazdur, Richard, Kluetz, Paul G, Singh, Harpreet
Published in The lancet oncology (01.04.2024)
Published in The lancet oncology (01.04.2024)
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Journal Article
FDA Approval Summary: Pembrolizumab, Atezolizumab, and Cemiplimab-rwlc as Single Agents for First-Line Treatment of Advanced/Metastatic PD-L1-High NSCLC
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
Published in Clinical cancer research (01.06.2022)
Published in Clinical cancer research (01.06.2022)
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Journal Article
FDA Approval Summary: Cabozantinib for Differentiated Thyroid Cancer
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
Published in Clinical cancer research (03.10.2022)
Published in Clinical cancer research (03.10.2022)
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Journal Article
FDA Approval Summary: Selumetinib for Plexiform Neurofibroma
Casey, Denise, Demko, Suzanne, Sinha, Arup, Mishra-Kalyani, Pallavi S, Shen, Yuan-Li, Khasar, Sachia, Goheer, M Anwar, Helms, Whitney S, Pan, Lili, Xu, Yuan, Fan, Jianghong, Leong, Ruby, Liu, Jiang, Yang, Yuching, Windsor, Katherine, Ou, Mei, Stephens, Olen, Oh, Byeongtaek, Reaman, Gregory H, Nair, Abhilasha, Shord, Stacy S, Bhatnagar, Vishal, Daniels, Selena R, Sickafuse, Sharon, Goldberg, Kirsten B, Theoret, Marc R, Pazdur, Richard, Singh, Harpreet
Published in Clinical cancer research (01.08.2021)
Published in Clinical cancer research (01.08.2021)
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Journal Article
FDA Approval Summary: Pembrolizumab for the Treatment of Patients with Unresectable or Metastatic Melanoma
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
Published in Clinical cancer research (01.10.2017)
Published in Clinical cancer research (01.10.2017)
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Journal Article
FDA Approval Summary: Pemigatinib for Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma with FGFR2 Fusion or Other Rearrangement
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
Published in Clinical cancer research (01.03.2023)
Published in Clinical cancer research (01.03.2023)
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Journal Article
FDA Approval Summary: Atezolizumab as Adjuvant Treatment following Surgical Resection and Platinum-Based Chemotherapy for Stage II to IIIA NSCLC
Mathieu, Luckson N, Larkins, Erin, Sinha, Arup K, Mishra-Kalyani, Pallavi S, Jafri, Samina, Kalavar, Shyam, Ghosh, Soma, Goldberg, Kirsten B, Pazdur, Richard, Beaver, Julia A, Singh, Harpreet
Published in Clinical cancer research (15.08.2023)
Published in Clinical cancer research (15.08.2023)
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Journal Article
FDA Approval Summary: Dabrafenib in Combination with Trametinib for BRAFV600E Mutation-Positive Low-Grade Glioma
Barbato, Michael I, Nashed, Jeannette, Bradford, Diana, Ren, Yi, Khasar, Sachia, Miller, Claudia P, Zolnik, Banu S, Zhao, Hong, Li, Yangbing, Bi, Youwei, Shord, Stacy S, Amatya, Anup K, Mishra-Kalyani, Pallavi S, Scepura, Barbara, Al-Matari, Raniya A, Pazdur, Richard, Kluetz, Paul G, Donoghue, Martha, Singh, Harpreet, Drezner, Nicole
Published in Clinical cancer research (17.01.2024)
Published in Clinical cancer research (17.01.2024)
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