Last Updated: 09/26/2026
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Found 30 publications
Is Progression-Free Survival 2 Ready for Prime Time in US Food and Drug Administration Regulatory Decision Making?
Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology
Published: March 30, 2026
Reply to: Decoding the End Points of Poly (ADP-ribose) Polymerase Inhibitor Trials in Ovarian Cancer.
Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology
Published: October 31, 2025
US Food and Drug Administration Approval Summary: Ribociclib With an Aromatase Inhibitor in the Adjuvant Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Stage II and III High-Risk Early Breast Cancer Treatment Setting.
Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology
Published: August 11, 2025
US Food and Drug Administration Approval Summary: Trastuzumab Deruxtecan for the Treatment of Adult Patients With Hormone Receptor-Positive, Unresectable or Metastatic Human Epidermal Growth Factor Receptor 2-Low or Human Epidermal Growth Factor Receptor 2-Ultralow Breast Cancer.
Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology
Published: August 05, 2025
Totality of the Evidence: Optimizing Dosage Selection Strategies in Oncology.
Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology
Published: July 24, 2025
Overall Survival and the Evolving Benefit-Risk Assessment for Poly (ADP-ribose) Polymerase Inhibitors in Advanced Ovarian Cancer.
Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology
Published: May 19, 2025
FDA Approval Summary: Datopotamab Deruxtecan-dlnk for Treatment of Patients with Unresectable or Metastatic, HR-Positive, HER2-Negative Breast Cancer.
Journal: Clinical cancer research : an official journal of the American Association for Cancer Research
Published: April 16, 2025
Dosage Optimization of Pediatric Oncology Products: Our Patients Deserve Better.
Journal: Clinical cancer research : an official journal of the American Association for Cancer Research
Published: January 07, 2025
The Johns Hopkins Hope at Hopkins Clinic: supporting the comprehensive needs of individuals with metastatic breast cancer.
Journal: Breast cancer research and treatment
Published: November 02, 2024
Using Quantitative Approaches to Optimize Dosages for New Combinations and Subsequent Indications for Oncology Drugs.
Journal: Clinical pharmacology and therapeutics
Published: October 07, 2024
FDA approval summary: fam-trastuzumab deruxtecan-nxki for unresectable or metastatic non-small cell lung cancer with activating HER2 mutations.
Journal: The oncologist
Published: April 11, 2024
Dosage Optimization: A Regulatory Perspective for Developing Oncology Drugs.
Journal: Clinical pharmacology and therapeutics
Published: February 26, 2024
Last Updated: 09/26/2026