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)
Get full text
Journal Article
FDA Approval Summary: Pembrolizumab plus Lenvatinib for Endometrial Carcinoma, a Collaborative International Review under Project Orbis
Arora, Shaily, Balasubramaniam, Sanjeeve, Zhang, Wei, Zhang, Lijun, Sridhara, Rajeshwari, Spillman, Dianne, Mathai, Jaigi P, Scott, Bradley, Golding, Sarah J, Coory, Michael, Pazdur, Richard, Beaver, Julia A
Published in Clinical cancer research (01.10.2020)
Published in Clinical cancer research (01.10.2020)
Get full text
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)
Get full text
Journal Article
Project Orbis: Global Collaborative Review Program
de Claro, R Angelo, Spillman, Dianne, Hotaki, Lauren Tesh, Shum, Michael, Mouawad, Laila Sofia, Santos, Gustavo Mendes Lima, Robinson, Kelly, Hunt, Melissa, Healy, Caroline, Chan, Agnes, Looi, Yee Hoo, Rodrigues, Clare, Rohr, Ulrich-Peter, Walther, Chantal, Pazdur, Richard
Published in Clinical cancer research (15.12.2020)
Published in Clinical cancer research (15.12.2020)
Get full text
Journal Article
FDA Approval Summary: Nivolumab with Ipilimumab and Chemotherapy for Metastatic Non-small Cell Lung Cancer, A Collaborative Project Orbis Review
Vellanki, Paz J, Mulkey, Flora, Jaigirdar, Adnan A, Rodriguez, Lisa, Wang, Yibo, Xu, Yuan, Zhao, Hong, Liu, Jiang, Howe, Grant, Wang, Jian, Choo, Qiuyi, Golding, Sarah J, Mansell, Victoria, Korsah, Kwadwo, Spillman, Dianne, de Claro, R Angelo, Pazdur, Richard, Beaver, Julia A, Singh, Harpreet
Published in Clinical cancer research (01.07.2021)
Published in Clinical cancer research (01.07.2021)
Get full text
Journal Article
FDA’s Oncology Center for Excellence Pilots Project Orbis: A framework for concurrent submission and review of oncology products among international partners
Spillman, Dianne, Arora, Shaily, Venugopal, Rajesh, Scott, Bradley, Golding, Sarah, Richardson, Nicholas, Kasamon, Yvette L., Ethier, Jean-Francois, Gurd, Kate, Singh, Harpreet, DeClaro, R. Angelo, Beaver, Julia A., Kim, Tamy, Goldberg, Kirsten B., Kluetz, Paul Gustav, Theoret, Marc Robert, Pazdur, Richard
Published in Journal of clinical oncology (20.05.2020)
Published in Journal of clinical oncology (20.05.2020)
Get full text
Journal Article
Comparative Expedited Regulatory Programs of U.S Food & Drug Administration and Project Orbis Partners
Hotaki, Lauren T., Shrestha, Anu, Bennett, Monica P., Valdes, Ivelisse L., Lee, Sso H., Wang, Yinghua, Spillman, Dianne, MacAulay, Tina, Hunt, Melissa, Gervais, Julie, Mafi, Maral, Panetta, Vincent, Looi, Yee Hoo, Shum, Michael, Atiek, Eiman, Meincke, Ricarda, Rohr, Ulrich-Peter, Ainbinder, Denize, Boehm-Cagan, Anat, Luxenburg, Osnat, Cerqueira, Mateus Rodrigues, Mouawad, Laila Sofia, Thees, Maria Fernanda Reis e Silva, Prasad, Krishna, de Claro, R. Angelo
Published in Therapeutic innovation & regulatory science (01.07.2023)
Published in Therapeutic innovation & regulatory science (01.07.2023)
Get full text
Journal Article