Assessment of benefits and risks in development of targeted therapies for cancer — The view of regulatory authorities

Por Pignatti, Francesco, Jonsson, Bertil, Blumenthal, Gideon, Justice, Robert
Publicado no Mol Oncol (2014)

Approval Summary: Pemetrexed Maintenance Therapy of Advanced/Metastatic Nonsquamous, Non-Small Cell Lung Cancer (NSCLC)

Por Cohen, Martin H., Cortazar, Patricia, Justice, Robert, Pazdur, Richard
Publicado em 2010

Approval Summary: Imatinib Mesylate in the Adjuvant Treatment of Malignant Gastrointestinal Stromal Tumors

Por Cohen, Martin H., Cortazar, Patricia, Justice, Robert, Pazdur, Richard
Publicado em 2010

Approval Summary: Letrozole (Femara® Tablets) for Adjuvant and Extended Adjuvant Postmenopausal Breast Cancer Treatment: Conversion of Accelerated to Full Approval

Por Cohen, Martin H., Johnson, John R., Justice, Robert, Pazdur, Richard
Publicado em 2011

Approval Summary: Imatinib Mesylate for One or Three Years in the Adjuvant Treatment of Gastrointestinal Stromal Tumors

Por Cohen, Martin H., Johnson, John R., Justice, Robert, Pazdur, Richard
Publicado em 2012

US Food and Drug Administration Approval Overview in Metastatic Breast Cancer

Por Cortazar, Patricia, Justice, Robert, Johnson, John, Sridhara, Rajeshwari, Keegan, Patricia, Pazdur, Richard
Publicado em 2012

Approval Summary: Erlotinib Maintenance Therapy of Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)

Por Cohen, Martin H., Johnson, John R., Chattopadhyay, Somesh, Tang, Shenghui, Justice, Robert, Sridhara, Rajeshwari, Pazdur, Richard
Publicado em 2010

FDA Approval Summary: Sunitinib for the Treatment of Progressive Well-Differentiated Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumors

Por Blumenthal, Gideon M., Cortazar, Patricia, Zhang, Jenny J., Tang, Shenghui, Sridhara, Rajeshwari, Murgo, Anthony, Justice, Robert, Pazdur, Richard
Publicado em 2012

FDA Approval Summary: Crizotinib for the Treatment of Metastatic Non-Small Cell Lung Cancer With Anaplastic Lymphoma Kinase Rearrangements

Por Kazandjian, Dickran, Blumenthal, Gideon M., Chen, Huan-Yu, He, Kun, Patel, Mona, Justice, Robert, Keegan, Patricia, Pazdur, Richard
Publicado em 2014

FDA Approval Summary: Temsirolimus as Treatment for Advanced Renal Cell Carcinoma

Por Kwitkowski, Virginia E., Prowell, Tatiana M., Ibrahim, Amna, Farrell, Ann T., Justice, Robert, Mitchell, Shan Sun, Sridhara, Rajeshwari, Pazdur, Richard
Publicado em 2010

In Reply

Por Kwitkowski, Virginia E., Prowell, Tatiana M., Ibrahim, Amna, Farrell, Ann T., Justice, Robert, Sun Mitchell, Shan, Sridhara, Rajeshwari, Pazdur, Richard
Publicado em 2010

U.S. Food and Drug Administration Approval Summary: Erlotinib for the First-Line Treatment of Metastatic Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Exon 19 De...

Por Khozin, Sean, Blumenthal, Gideon M., Jiang, Xiaoping, He, Kun, Boyd, Karen, Murgo, Anthony, Justice, Robert, Keegan, Patricia, Pazdur, Richard
Publicado em 2014