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Start Over Author "Donna Roscoe" Journal clinical cancer research : an official journal of the american association for cancer research
2 results on '"Donna Roscoe"'

1. FDA Approval Summary: Selpercatinib for the Treatment of Lung and Thyroid Cancers with

Author

Diana, Bradford, Erin, Larkins, Sirisha L, Mushti, Lisa, Rodriguez, Amy M, Skinner, Whitney S, Helms, Lauren S L, Price, Jeanne Fourie, Zirkelbach, Yangbing, Li, Jiang, Liu, Rosane, Charlab, Francisca Reyes, Turcu, Dun, Liang, Soma, Ghosh, Donna, Roscoe, Reena, Philip, Autumn, Zack-Taylor, Shenghui, Tang, Paul G, Kluetz, Julia A, Beaver, Richard, Pazdur, Marc R, Theoret, and Harpreet, Singh

Subjects
Adult, Lung Neoplasms, Clinical Trials, Phase I as Topic, Oncogene Proteins, Fusion, Pyridines, United States Food and Drug Administration, Proto-Oncogene Proteins c-ret, United States, Clinical Trials, Phase II as Topic, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols, Mutation, Humans, Multicenter Studies as Topic, Pyrazoles, Thyroid Neoplasms, Child, Drug Approval, Protein Kinase Inhibitors
Abstract

On May 8, 2020, the FDA granted accelerated approval to selpercatinib for (i) adult patients with metastatic

Published
2020

2. FDA approval summary: vemurafenib for treatment of unresectable or metastatic melanoma with the BRAFV600E mutation

Author

Maitreyee Hazarika, Rajeshwari Sridhara, Xiaoping Jiang, Qiang Casey Xu, Whitney S. Helms, Richard Pazdur, Sarah Pope Miksinski, Kun He, Yang-Min Ning, Justin C. Earp, Shenghui Tang, Anne Marie Russell, Qi Liu, John R. Johnson, Amna Ibrahim, Amy E. McKee, W. David McGuinn, Donna Roscoe, Jeanne Fourie Zirkelbach, Geoffrey Kim, Robert Justice, and Marc R. Theoret

Subjects
Proto-Oncogene Proteins B-raf, Cancer Research, medicine.medical_specialty, Indoles, Nausea, Dacarbazine, Drug Evaluation, Preclinical, Antineoplastic Agents, QT interval, Gastroenterology, Internal medicine, medicine, Animals, Humans, Neoplasm Metastasis, Vemurafenib, Drug Approval, Melanoma, Clinical Trials as Topic, Sulfonamides, business.industry, United States Food and Drug Administration, medicine.disease, Rash, Toxic epidermal necrolysis, United States, Surgery, Treatment Outcome, Oncology, Mutation, medicine.symptom, business, Uveitis, V600E, medicine.drug
Abstract

On August 17, 2011, the U.S. Food and Drug Administration (FDA) approved vemurafenib tablets (Zelboraf, Hoffmann-LaRoche Inc.) for the treatment of patients with unresectable or metastatic melanoma with the BRAFV600E mutation as detected by an FDA-approved test. The cobas 4800 BRAF V600 Mutation Test (Roche Molecular Systems, Inc.) was approved concurrently. An international, multicenter, randomized, open-label trial in 675 previously untreated patients with BRAFV600E mutation–positive unresectable or metastatic melanoma allocated 337 patients to receive vemurafenib, 960 mg orally twice daily, and 338 patients to receive dacarbazine, 1,000 mg/m2 intravenously every 3 weeks. Overall survival was significantly improved in patients receiving vemurafenib [HR, 0.44; 95% confidence interval (CI), 0.33–0.59; P < 0.0001]. Progression-free survival was also significantly improved in patients receiving vemurafenib (HR, 0.26; 95% CI, 0.20–0.33; P < 0.0001). Overall response rates were 48.4% and 5.5% in the vemurafenib and dacarbazine arms, respectively. The most common adverse reactions (≥30%) in patients treated with vemurafenib were arthralgia, rash, alopecia, fatigue, photosensitivity reaction, and nausea. Cutaneous squamous cell carcinomas or keratoacanthomas were detected in approximately 24% of patients treated with vemurafenib. Other adverse reactions included hypersensitivity, Stevens–Johnson syndrome, toxic epidermal necrolysis, uveitis, QT prolongation, and liver enzyme laboratory abnormalities. Clin Cancer Res; 20(19); 4994–5000. ©2014 AACR.

Published
2014

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