Notizie Newsletter
FDA Panel Supports Pembrolizumab for High-Risk NMIBC
December 17, 2019 - The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 9 to 4 supporting the approval of a new drug application (NDA) for pembrolizumab for the treatment of patients with Bacillus Calmette-Guerin (BCG)–unresponsive, high-risk, non-muscle ...Leggi tutto
Statement on low-cost biosimilar and interchangeable protein products
December 17, 2019 - Ensuring an efficient pathway to bring potentially lower-cost biosimilar and interchangeable protein products to market is key for expanding access to these products and increasing competition, ultimately helping American patients. In March 2020 most ...Leggi tutto
FDA Grants Priority Review to Encorafenib/Cetuximab Combo for BRAF+ mCRC
December 18, 2019 - The FDA has granted a priority review designation to a supplemental new drug application (sNDA) for the combination of encorafenib and cetuximab as a treatment for patients with advanced BRAF V600E–mutant metastatic colorectal cancer (mCRC) following ...Leggi tutto
Tucatinib, Trastuzumab, and Capecitabine for HER2-Positive Metastatic Breast Cancer
Patients with human epidermal growth factor receptor 2 (HER2)–positive metastatic breast cancer who have disease progression after therapy with multiple HER2-targeted agents have limited treatment options. Tucatinib is an investigational, oral, highly selective inhibitor ...Leggi tutto
ASCO Congratulates Stephen M. Hahn, MD, FASTRO, on Confirmation as FDA Commissioner
December 12, 2019 - "The American Society of Clinical Oncology (ASCO) congratulates Stephen M. Hahn, MD, FASTRO, on his confirmation by the United States Senate to serve as the next Commissioner of the U.S. Food and Drug Administration (FDA). "An oncologist with more than ...Leggi tutto
Entrectinib in patients with advanced or metastatic NTRK fusion-positive solid tumours: integrated analysis of three phase 1-2 trials
Entrectinib is a potent inhibitor of tropomyosin receptor kinase (TRK) A, B, and C, which has been shown to have anti-tumour activity against NTRK gene fusion-positive solid tumours, including CNS activity due to its ability to penetrate the blood–brain barrier. We ...Leggi tutto