Caroline Hopkins

Articles Authored by Caroline Hopkins
The agency acknowledges its staff can't keep up with the volume of cell and gene therapy products and is looking to PDUFA VII for additional funds.Â

While low FGFR biomarker testing rates may be contributing to the drug's slow adoption, the analysis found low uptake even among patients who did get tested.

Intermountain Healthcare Rolling Out Galleri Multi-Cancer Early Detection Test in Pilot Program
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The test is first available to employees over age 50 covered under Intermountain's SelectHealth, but the health system has a bigger five-year plan.

ESMO Advances Biomarker Framework to Guide Cancer Therapy De-Intensification, Decision-Making
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The framework, which ranks de-intensification biomarkers by evidence tiers, could give oncologists, patients, regulators, and payors a common system to guide their use.

MSK to Launch Trial of T-Cell Receptor Therapy Targeting Common Neoantigen With Pharma Partner
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The therapy, which could potentially have tissue-agnostic use, is designed to target a public neoantigen from a mutation in the oncogenic driver gene PIK3CA.

Trial data and real-world evidence support treatment combos with Novartis' Kisqali and Pfizer's Ibrance, respectively, for HR-positive, HER2-negative breast cancer.Â
International LAGENO-BC Consortium Spurring Breast Cancer Genetics Research Across Latin America
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The consortium, which includes 13 studies in seven countries, was formed to support breast cancer genetic research across Latin American and Hispanic populations.

Preclinical Data In Hand, City of Hope to Study Anti-TAG72 CAR T-Cell Therapy for Ovarian Cancer
At AACR, researchers described plans for an upcoming trial of an autologous CAR T-cell therapy infused directly into the peritoneal cavity of epithelial ovarian cancer patients.

New Epigenomic Biomarker Could Predict CAR T-Cell Therapy Resistance in Advanced Childhood Leukemia
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At AACR, researchers described how pediatric ALL patients who don't respond to anti-CD19 CAR T-cell therapy have cancers with a unique, stem cell-like epigenome.

Adding Genetic Information to PSA Improves Biomarker's Performance in Prostate Cancer Diagnosis
AACR research showed that incorporating a genetic risk score of prostate-specific antigen variation made the controversial biomarker more sensitive and specific.
