Although patients with cancer have high rates of comorbidities that often correlate with poorer outcomes and complicate treatment decisions, hard data are frequently lacking on the interaction between specific regimens and health conditions. Oncology experts are increasingly turning their attention to the disconnect between patient populations recruited for the clinical trials that lead to…
Individuals with HIV are living longer than ever due to tremendous advances in treatment. However, as survival has increased, so has the incidence of cancer. Malignancy is a leading cause of mortality for this population. Individuals with HIV have a substantially higher risk for certain types of cancer than the general population. Typical AIDS-defining…
In December 2017, the National Cancer Institute (NCI) announced that preliminary results from an NCI-sponsored phase I clinical trial showed it can be safe to treat HIV-positive cancer patients with the immunotherapy drug Keytruda (pembrolizumab). The NCI’s HIV and AIDS Malignancy Branch and the Cancer Immunotherapy Trials Network launched the trial in 2016 at…
PMC to Present Ellen V. Sigal With 14th Annual Award for Leadership in Personalized Medicine Nomination letters praise Sigal as ‘fundamental change agent’ for field WASHINGTON (June 20, 2018) — In recognition of her impact as a “fundamental change agent” for personalized medicine, the Personalized Medicine Coalition (PMC) is pleased to announce its selection of…
In a world of major cancer advances, and a growing arsenal of innovative therapies, eligibility criteria for clinical trials haven’t changed in 20 years. Edward Kim, MD, chair of solid tumor oncology at Carolinas Healthcare’s Levine Cancer Institute in Charlotte, N.C., has been trying to rectify this anachronism. Kim discussed it at the American Society…
Executive Summary In addition to reviewing proposed lists of targets for relevance to pediatric cancer, advisory committee will discuss possible criteria for prioritizing same-in-class agents for evaluation and ways to promote international collaboration and global development; proposed list of substantially relevant targets is growing. A US FDA advisory committee’s views on the development and…
Executive Summary New York Times editorial is critical of approving drugs based on one clinical trial, recommends independent cost benefit analysis. A New York Times editorial recommending that the US FDA go back to requiring two clinical trials for approval of any drug elicited a series of tweets from Commissioner Scott Gottlieb, who explained…
Cancer Network: There are already a few immunotherapy-immunotherapy combinations approved for melanoma, and also two targeted therapy combinations. What have we learned so far about the development of these types of combinations that could help us develop additional combination regimens for melanoma and other tumor types? Dr. Wargo: I think what we’ve learned is…
A Florida woman diagnosed with advanced breast cancer, generally considered incurable, is free of the disease two-and-a-half years after a novel therapy used her own immune cells to target her tumors, researchers said Monday. Striking recoveries were reported earlier for a patient with deadly liver cancer and another with advanced colon cancer. The three…
The American College of Clinical Pharmacology (ACCP) recently published a Policy Statement reviewing ways in which clinical pharmacology can and should make an effort to include organ-impaired patients in oncology trials. The announcement identifies key discussions needed among industry, regulators, and clinicians prior to the widespread adoption of expanded eligibility criteria for such trials. …
