Nicole J. Gormley

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

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

The Food and Drug Administration pooled analysis of overall survival according to depth of response in frontline advanced immune-oncology renal cell carcinoma trials.

Journal: JNCI cancer spectrum

Published: April 21, 2025

Autopsy of a Drug Withdrawal - The Case of Melphalan Flufenamide.

Journal: The New England journal of medicine

Published: December 09, 2024

FDA Approval Summary: Polatuzumab Vedotin in the First-Line Treatment of Select Large B-Cell Lymphomas.

Journal: Clinical cancer research : an official journal of the American Association for Cancer Research

Published: June 20, 2024

FDA Approval Summary: Teclistamab-A Bispecific CD3 T-Cell Engager for Patients with Relapsed or Refractory Multiple Myeloma.

Journal: Clinical cancer research : an official journal of the American Association for Cancer Research

Published: June 18, 2024

Improving Collection and Analysis of Overall Survival Data.

Journal: Clinical cancer research : an official journal of the American Association for Cancer Research

Published: March 20, 2024

Round Table Discussion on Optimal Clinical Trial Design in Precursor Multiple Myeloma.

Journal: Blood cancer discovery

Published: March 05, 2024

Highlights of FDA Oncology Approvals in 2023: Bispecific T-cell Engagers, Pediatric Indications, and Inclusive Drug Development.

Journal: Cancer discovery

Published: December 12, 2023

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.

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.

Overall Survival and the Evolving Benefit-Risk Assessment for Poly (ADP-ribose) Polymerase Inhibitors in Advanced Ovarian Cancer.

Overall Survival and the Evolving Benefit-Risk Assessment for Poly (ADP-ribose) Polymerase Inhibitors in Advanced Ovarian Cancer.

The Food and Drug Administration pooled analysis of overall survival according to depth of response in frontline advanced immune-oncology renal cell carcinoma trials.

The Food and Drug Administration pooled analysis of overall survival according to depth of response in frontline advanced immune-oncology renal cell carcinoma trials.

Autopsy of a Drug Withdrawal - The Case of Melphalan Flufenamide.

Autopsy of a Drug Withdrawal - The Case of Melphalan Flufenamide.

FDA Approval Summary: Polatuzumab Vedotin in the First-Line Treatment of Select Large B-Cell Lymphomas.

FDA Approval Summary: Polatuzumab Vedotin in the First-Line Treatment of Select Large B-Cell Lymphomas.

FDA Approval Summary: Teclistamab-A Bispecific CD3 T-Cell Engager for Patients with Relapsed or Refractory Multiple Myeloma.

FDA Approval Summary: Teclistamab-A Bispecific CD3 T-Cell Engager for Patients with Relapsed or Refractory Multiple Myeloma.

Improving Collection and Analysis of Overall Survival Data.

Improving Collection and Analysis of Overall Survival Data.

Round Table Discussion on Optimal Clinical Trial Design in Precursor Multiple Myeloma.

Round Table Discussion on Optimal Clinical Trial Design in Precursor Multiple Myeloma.

Highlights of FDA Oncology Approvals in 2023: Bispecific T-cell Engagers, Pediatric Indications, and Inclusive Drug Development.

Highlights of FDA Oncology Approvals in 2023: Bispecific T-cell Engagers, Pediatric Indications, and Inclusive Drug Development.

A Pooled Analysis of Treatment-Free Survival in Advanced Renal Cell Carcinoma.

A Pooled Analysis of Treatment-Free Survival in Advanced Renal Cell Carcinoma.

FDA Approval Summary: Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma.

FDA Approval Summary: Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma.

Irreconcilable Differences: The Divorce Between Response Rates, Progression-Free Survival, and Overall Survival.

Irreconcilable Differences: The Divorce Between Response Rates, Progression-Free Survival, and Overall Survival.