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Showing 1–8 of 8 results
Advanced filters: Author: Gideon Blumenthal Clear advanced filters

  • In 2016, FDA Oncology approved five new molecular entities and 17 efficacy supplements, including six accelerated approvals, 17 priority reviews, and 11 approvals of breakthrough-designated therapies. The FDA also approved five companion diagnostics, including a liquid biopsy test. One new anti-PD-L1 antibody was approved, along with six supplementary approvals of anti-PD-1/PD-L1 antibodies.

    • Gideon M. Blumenthal
    • Richard Pazdur
    Comments & Opinion
    Nature Reviews Clinical Oncology
    Volume: 14, P: 131-132

  • In 2018, the FDA approved 19 new drug and biologic applications, 38 supplemental drug and biologic applications and 4 biosimilar applications in oncology. These advances in anticancer therapy included a landmark approval of the first histology-agnostic, biomarker-defined new molecular entity and approvals based on real-time data review and novel end points, such as minimal residual disease rate and metastasis-free survival.

    • Gideon M. Blumenthal
    • Richard Pazdur
    Comments & Opinion
    Nature Reviews Clinical Oncology
    Volume: 16, P: 139-141

  • In 2017, FDA Oncology approved 17 new drug and biologic applications, 32 supplemental drug and biologic applications, and two biosimilar applications in oncology. These actions included landmark approvals of two chimeric antigen receptor T cell therapies and the first site-agnostic, biomarker-defined approval. Three next-generation sequencing 'oncopanels' designed to detect hundreds of somatic genetic aberrations were also approved.

    • Gideon M. Blumenthal
    • Richard Pazdur
    Comments & Opinion
    Nature Reviews Clinical Oncology
    Volume: 15, P: 127-128

  • In 2019, the FDA Oncology Center of Excellence (OCE) approved 11 new drugs and biologic agents, 30 supplemental drug and biologic applications, and four biosimilar applications in oncology. These included two landmark approvals involving collaboration among international regulators as part of OCE Project Orbis, as well as the approval of three novel antibody–drug conjugates.

    • Harpreet Singh
    • Gideon Blumenthal
    • Richard Pazdur
    Comments & Opinion
    Nature Reviews Clinical Oncology
    Volume: 17, P: 130-131

  • PTENis one of the most frequently inactivated tumour suppressor genes in cancer, and approximately 80% of patients with Cowden syndrome have mutations inPTEN. This Review discusses the different types of PTEN-mutant tumours that occur in Cowden syndrome and the mouse models that have been engineered to study them.

    • M. Christine Hollander
    • Gideon M. Blumenthal
    • Phillip A. Dennis
    Reviews
    Nature Reviews Cancer
    Volume: 11, P: 289-301