Brain Cancer | Clinical

FDA to Release Guidance on Evaluating Cancer Drugs for Brain Metastases

August 31, 2020

The FDA announced draft guidance, which provides recommendations for the design of clinical trials and biological products for product labeling for those with brain metastases regulated by the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research.

Modern Therapies Offer a Way to Reach the Brain in HER2+ Metastatic Breast Cancer

August 14, 2020

In an interview with Targeted Oncology, Stephanie Weiss, MD, reviewed the treatment landscape for HER2-positive metastatic breast cancer and gave her predictions on how the paradigm will evolve for patients with brain metastases now that tucatinib has demonstrated efficacy.

Pooled Analysis Reveals Long-Term Effect on QoL and Cognitive Outcomes From Radiation for Brain Metastases

August 14, 2020

In the first pooled prospective study to show the long-term outcomes of cranial radiation in patients with limited brain metastases, it was observed that whole-brain radiotherapy was associated with worse cognitive outcomes and mixed quality of life compared with stereotactic radiosurgery for these patients over time, according to a presentation from Joshua Palmer, MD, at the 2020 Virtual Conference on Brain Metastases.

Radiosurgery Improves Clinical Outcomes in Brain Metastasis Treatment

August 14, 2020

Joshua Palmer, MD, discusses a pooled analysis of 2 randomized clinical trials that compared how clinical outcomes and quality of life were impacted with stereotactic radiosurgery versus whole-brain radiation therapy in patients with brain metastases.

Tucatinib Combination Demonstrates Multiple Positive Responses in HER2-Positive Metastatic Breast Cancer

August 14, 2020

Multiple positive responses were observed in an exploratory efficacy analysis evaluating tucatinib in combination with trastuzumab and capecitabine in patients with previously treated HER2-positive metastatic breast cancer with brain metastases in the previously reported HER2CLIMB trial.

Omburtamab BLA Submitted for FDA Approval in CNS/Leptomeningeal Metastasis From Neuroblastoma

August 06, 2020

A completed Biologics License Application was submitted to the FDA for omburtamab, an investigation monoclonal antibody, which is intended for the treatment of pediatric patients with central nervous system/leptomeningeal metastasis from neuroblastoma.