In this second installment of our nine-part deep-dive into the U.S. Food & Drug Administration (“FDA” or “the Agency”) final rule on Laboratory Developed Tests (“LDTs”) – which established a staged plan that will phase out the Agency’s previous policy of enforcement discretion for LDTs – we are taking a closer look at the response to the…
The Association for Molecular Pathology on Thursday published a new set of evidence-based recommendations for the analytical validation and reporting of tumor mutational burden (TMB) testing. TMB is a predictive biomarker for immune checkpoint inhibitor (ICI) therapies, which takes the form of a score derived as a measure of the number of mutations per sequenced…
CHICAGO — Healio once again welcomed the excitement of the Disruptive Innovator Awards, working with new partners and celebrating nine distinct areas of progress in oncology and hematology. Hosted again by Shikha Jain, MD, FACP, joined this year by Mark A. Lewis, MD, as the “understudy” to Edward S. Kim, MD, MBA, FACP, FASCO, who had family celebrations, the ceremony followed a great turnout…
NEW YORK – In February, cell therapy developers, researchers, and oncologists celebrated Iovance Biotherapeutics’ Amtagvi (lifileucel) US approval in advanced melanoma. As the first autologous cell therapy to win authorization in a solid tumor setting, its path to market could be a model for others to follow. “Finally, we got an adopted cell therapy for a solid tumor,” Kai He, an oncologist at Ohio State…
The starting point for the US Food and Drug Administration’s approach to addressing “intentional heterogeneity” in the next wave of cellular products remains full characterization of new products prior to clinical trials, despite researchers’ calls to move the products into the clinic sooner and adapt the trials along the way. The agency is preparing for…
The next evolution of gene therapies may involve pitting T cells with different modifications against one another in a “race” inside a human to determine which edits produce the best results against a tumor, an expert panel predicted. Researchers across the globe have discovered dozens of genes that could be targeted to make T cells…
Homologous recombination deficiency tests are available from multiple vendors, and every day they are used to determine whether patients stand to benefit from PARP inhibitors. In an effort to determine whether these tests produce consistent results, a research project led by Friends of Cancer Research sent identical samples from 90 ovarian cancer patients to 17…
Peter Marks, director of the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER), said his center is doing a “pretty good job” of filling positions under the current Prescription Drug User Fee Act (PDUFA VII) agreement at a meeting sponsored by the Friends for Cancer Research (FOCR) and Parker Institute…
Seven years after the approval of the first chimeric antigen receptor T-cell therapies, the Center for Biologics Evaluation and Research is starting to see a “branching out” within cell-based gene therapies into “much more complicated constructs,” CBER Director Peter Marks said during a 6 May webinar sponsored by the Friends of Cancer Research and Parker Institute for…
In a study involving more than 1,500 patients who were treated with chimeric antigen-receptor (CAR) T-cell therapy at the University of Pennsylvania (Penn) in Philadelphia and at Stanford University in California, just 2.3% and 3.4% of patients, respectively, later developed secondary cancers. Notably, none of the cancers were directly linked to CARs—with no insertions of CAR…
