Search

Your search keyword '"Auth, Doris"' showing total 9 results
Start Over Author "Auth, Doris"
9 results on '"Auth, Doris"'

1. FDA Approval Summary: Durvalumab and Pembrolizumab, Immune Checkpoint inhibitors for the Treatment of Biliary Tract Cancer

Author

Casak, Sandra J., primary, Kumar, Vaibhav, additional, Song, Chi, additional, Yuan, Mengdie, additional, Amatya, Anup K., additional, Cheng, Joyce, additional, Mishra-Kalyani, Pallavi S., additional, Tang, Shenghui, additional, Lemery, Steven J., additional, Auth, Doris, additional, Davis, Gina, additional, Kluetz, Paul G., additional, Pazdur, Richard, additional, and Fashoyin-Aje, Lola A., additional

Published
2024
Full Text
View/download PDF

2. FDA Approval Summary: Fruquintinib for the Treatment of Refractory Metastatic Colorectal Cancer

Author

Fusco, Michael J., primary, Casak, Sandra J., additional, Mushti, Sirisha L., additional, Cheng, Joyce, additional, Christmas, Brian J., additional, Thompson, Matthew D., additional, Fu, Wentao, additional, Wang, Hezhen, additional, Yoon, Miyoung, additional, Yang, Yuching, additional, Moore, Jason N., additional, Bi, Youwei, additional, Nan, Yang, additional, Long, Craig E., additional, Auth, Doris, additional, Rahman, Nam Atiqur., additional, Tang, Shenghui, additional, Pazdur, Richard, additional, Fashoyin-Aje, Lola A., additional, Kluetz, Paul G., additional, and Lemery, Steven J., additional

Published
2024
Full Text
View/download PDF

4. FDA Approval Summary: Futibatinib for Unresectable Advanced or Metastatic, Chemotherapy Refractory Intrahepatic Cholangiocarcinoma with FGFR2 Fusions or Other Rearrangements

Author

Gandhy, Shruti U., primary, Casak, Sandra J., additional, Mushti, Sirisha L., additional, Cheng, Joyce, additional, Subramaniam, Sriram, additional, Zhao, Hong, additional, Zhao, Miao, additional, Bi, Youwei, additional, Liu, Guansheng, additional, Fan, Jianghong, additional, Adeniyi, Oluseyi, additional, Charlab, Rosane, additional, Kufrin, Dubravka, additional, Thompson, Matthew D., additional, Jarrell, Kristin, additional, Auth, Doris, additional, Lemery, Steven J., additional, Pazdur, Richard, additional, Kluetz, Paul G., additional, and Fashoyin-Aje, Lola A., additional

Published
2023
Full Text
View/download PDF

9. FDA Approval Summary: Tucatinib with Trastuzumab for Advanced Unresectable or Metastatic, Chemotherapy Refractory, HER2-Positive RAS Wild-Type Colorectal Cancer.

Author

Casak SJ, Horiba MN, Yuan M, Cheng J, Lemery SJ, Shen YL, Fu W, Moore JN, Li Y, Bi Y, Auth D, Fesenko N, Kluetz PG, Pazdur R, and Fashoyin-Aje LA

Subjects
Humans, Female, Trastuzumab, Receptor, ErbB-2 genetics, Receptor, ErbB-2 therapeutic use, Quinazolines, Antineoplastic Combined Chemotherapy Protocols adverse effects, Colorectal Neoplasms drug therapy, Colorectal Neoplasms genetics, Breast Neoplasms drug therapy
Abstract

On January 19, 2023, the FDA granted accelerated approval to tucatinib in combination with trastuzumab for the treatment of patients with unresectable or metastatic RAS wild-type, HER2-positive colorectal cancer who have received prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan. Approval was based on the pooled analysis of patients receiving tucatinib in combination with trastuzumab in MOUNTAINEER (NCT03043313), an open-label, multicenter trial. The primary endpoint was overall response rate (ORR) by RECIST 1.1 as per blinded central review committee (BIRC) assessment. The main secondary endpoint was duration of response (DOR) per BIRC assessment. Eighty-four eligible patients received the combination tucatinib and trastuzumab. With a median follow-up of 16 months, the ORR was 38% [95% confidence interval (CI): 28-49] and median DOR was 12.4 months (95% CI: 8.5-20.5); 81% of responders had a response lasting more than 6 months. The most common adverse reactions observed in at least 20% of patients receiving tucatinib in combination with trastuzumab were diarrhea, fatigue, rash, nausea, abdominal pain, infusion-related reactions, and fever. FDA concluded that the magnitude of ORR and durable responses observed in patients treated with tucatinib in combination with trastuzumab in the MOUNTAINEER trial are clinically meaningful, particularly in the context of a disease with estimated survival of 6-7 months with available therapy. This is the first approval for the subset of patients with HER2-positive colorectal cancer. This article summarizes the FDA's thought process and review of the data supporting this accelerated approval., (©2023 American Association for Cancer Research.)

Published
2023
Full Text
View/download PDF

Catalog

Books, media, physical & digital resources
See catalog results