Richard Pazdur, MD, on the Launch of Project Facilitate
2019 ASCO Annual Meeting
Richard Pazdur, MD, Director of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence and Acting Director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, discusses the launch of Project Facilitate, a new pilot program to assist oncology health-care professionals in requesting access to unapproved therapies for patients with cancer.
Contact Information for Project Facilitate
Health-Care Professionals
Call: 1-240-402-0004
Patients and Their Families
Call: 301-796-3400
Sara A. Hurvitz, MD, of the UCLA Jonsson Comprehensive Cancer Center, discusses the first study of ribociclib plus endocrine therapy vs endocrine therapy alone to demonstrate significantly longer overall survival in peri- and premenopausal women with advanced breast cancer (Abstract LBA1008).
William D. Tap, MD, of Memorial Sloan Kettering Cancer Center, discusses negative study findings on doxorubicin plus olaratumab vs doxorubicin plus placebo, which showed no difference in overall survival between the two treatments in patients with advanced soft-tissue sarcomas. The manufacturer is currently withdrawing olaratumab from the global market (Abstract LBA3).
Matteo Lambertini, MD, PhD, of the University of Genova and Policlinico San Martino Hospital, and Hope S. Rugo, MD, of the University of California, San Francisco, discuss findings from the SOPHIA trial on margetuximab plus chemotherapy vs trastuzumab plus chemotherapy in patients with HER2-positive metastatic breast cancer after prior anti-HER2 therapies (Abstract 1000).
Gilberto Lopes, MD, MBA, of the Sylvester Comprehensive Cancer Center at the University of Miami, offers commentary on phase III findings from the RELAY study, which showed that erlotinib plus ramucirumab led to superior progression-free survival in previously untreated patients with EGFR mutant–positive NSCLC (Abstract 9000).
Ahmad A. Tarhini, MD, PhD, of Emory University and Winship Cancer Institute, discusses phase III findings from the U.S. Intergroup E1609 trial, which showed survival benefits for patients with resected high-risk melanoma—for the first time in the history of melanoma adjuvant therapy (Abstract 9504).
