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Category: In the News

Healio — Racing modified cells against each other in humans may be the next step in gene therapies

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…

The Cancer Letter — NCI’s Lisa McShane: We need to understand the implications of HRD assay discordance

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…

Regulatory Focus — Top FDA officials discuss PDUFA hiring, rapid communication, and international collaboration efforts

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…

Pink Sheet — Beyond CAR-Ts: Cell-Based Gene Therapy Sponsors Are ‘Branching Out,’ CBER’s Marks Says

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…

Cancer Discovery News — Researchers: No Secondary Cancers Tied Directly to CARs in Study

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…

Politico Pro — Inflation’s hit to the FDA

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…

BioSpace — Preliminary Findings Point to Low Risk of Secondary Cancers from CAR-T Therapies

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…

Endpoints News — UPenn and Stanford analysis finds no secondary cancer cases directly due to CAR-T

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…

Pink Sheet — It’s Official: FDA Drops Final Rule On LDTs

The US Food and Drug Administration announced its final rule for regulating lab-developed tests on 29 April, marking the launch of a new era of in vitro diagnostics. Notably, the agency’s final rule provides a broader-than-expected exemption for LDTs already on the market as of 6 May, the scheduled date for publication in the Federal Register, while…

Washington Post — FDA moves to regulate some tests it says may be unreliable

The Food and Drug Administration has finalized a divisive plan to regulate laboratory medical tests — including some used to diagnose cancer and Alzheimer’s disease — over concerns about reliability and risks to patients. The agency says inaccurate results may force patients to unnecessarily start a new treatment or delay care. Federal officials maintain that granting…