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.
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.
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.
The framework, which ranks de-intensification biomarkers by evidence tiers, could give oncologists, patients, regulators, and payors a common system to guide their use.
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.
The consortium, which includes 13 studies in seven countries, was formed to support breast cancer genetic research across Latin American and Hispanic populations.
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.
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.
AACR research showed that incorporating a genetic risk score of prostate-specific antigen variation made the controversial biomarker more sensitive and specific.