Drugs

10 Recommendations to Transform Cancer

The “Cancer Moonshot” Blue Ribbon Panel has issued a report with 10 recommendations it says could lead to significant advances in the understanding of cancer and how to intervene in its initiation and progression. The Blue Ribbon Panel included cancer researchers, oncologists, patient advocates, and representatives from government and the private sector. It established seven working groups to assess the state of the science in specific areas and identify major research opportunities that could uniquely benefit from Cancer Moonshot support.

The working groups looked at clinical trials, enhanced data sharing, cancer immunology, implementation science, pediatric cancer, precision prevention and early detection, and tumor evolution and progression. They said that the most compelling research opportunities that should be supported through the Cancer Moonshot include:

direct patient engagement through a federated network where patients are offered comprehensive tumor profiling;
cancer immunotherapy clinical trials network to develop and implement a rational strategy to discover and evaluate novel immune-based approaches;
therapeutic target identification to overcome drug resistance;
a national cancer data ecosystem for sharing and analysis;
fusion oncoproteins in pediatric cancer;
symptom management research;
implementation of evidence-based approaches for prevention and early detection;
retrospective analysis of biospecimens from patients treated with standard of care;
generation of human tumor atlases; and
development of new enabling cancer technologies.

“Cancer Moonshot funding would enable a remarkable level of coordination, especially across organizations, that will allow data from many difference researchers, clinicians, and patients across the country to be assembled in new ways that will help them be of use to patients, doctors, and researchers,” the report concludes.

Several of the working groups identified issues beyond the scope of the panel’s scientific charge that were forwarded to Vice President Joe Biden’s Moonshot task force. They included coverage and reimbursement, privacy and consent with regard to patient data, fragmentation of the delivery of patient care in the community, needed improvements in the clinical trial system, incentives to encourage pediatric drug development, new federal research funding models, and barriers to data sharing.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome