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…
FOCUS ON CELL, GENE THERAPIES — Hiring personnel with expertise in cell and gene therapies remains a challenge at the FDA, but senior officials said Monday they’re optimistic about the progress they’ve made so far. CBER’s Office of Therapeutic Products has done well in hiring the allotted personnel under the prescription drug user fee program, which was…
New research from the University of Pennsylvania and Stanford University finds no link between CAR-T cell therapies and the development of secondary T-cell malignancies. At a joint event held by the Friends of Cancer Research and Parker Institute for Cancer Immunotherapy on Monday, cell therapy pioneer Carl June of the University of Pennsylvania Perelman School of Medicine…
The University of Pennsylvania’s pioneering cell therapy physician Carl June shared new data Monday that showed the risk of secondary cancers following CAR-T therapy was very low. In over 1,500 patients treated at UPenn and Stanford University, only a small percentage had a second cancer after treatment, June reported Monday morning at a Friends of…
