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The FDA has scheduled an Oncologic Drugs Advisory Committee hearing for May 24, 2017, to discuss a new drug application for neratinib as a treatment for patients with HER2-positive breast cancer following prior treatment with postoperative trastuzumab, according to a statement from the developer of the TKI, Puma Biotechnology.

Research on a scalp-cooling device to help patients with breast cancer avoid hair loss during chemotherapy illustrates this question: what level of evidence might individual clinicians require before they would suggest, recommend, or support the use of a particular approach in treating patients outside the realm of the mandates of governmental agencies or payers?