John K. Leighton
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View article: Supplementary Table S2 from FDA Approval Summary: Niraparib plus Abiraterone Acetate Fixed-Dose Combination for <i>BRCA</i>-Mutated Metastatic Castration-Resistant Prostate Cancer
Supplementary Table S2 from FDA Approval Summary: Niraparib plus Abiraterone Acetate Fixed-Dose Combination for <i>BRCA</i>-Mutated Metastatic Castration-Resistant Prostate Cancer Open
Exploratory efficacy results by type of BRCA mutation in MAGNITUDE
View article: Supplementary Table S1 from FDA Approval Summary: Niraparib plus Abiraterone Acetate Fixed-Dose Combination for <i>BRCA</i>-Mutated Metastatic Castration-Resistant Prostate Cancer
Supplementary Table S1 from FDA Approval Summary: Niraparib plus Abiraterone Acetate Fixed-Dose Combination for <i>BRCA</i>-Mutated Metastatic Castration-Resistant Prostate Cancer Open
Summary of molecular alterations in Cohort 1 of MAGNITUDE
View article: Supplementary Table S3 from FDA Approval Summary: Niraparib plus Abiraterone Acetate Fixed-Dose Combination for <i>BRCA</i>-Mutated Metastatic Castration-Resistant Prostate Cancer
Supplementary Table S3 from FDA Approval Summary: Niraparib plus Abiraterone Acetate Fixed-Dose Combination for <i>BRCA</i>-Mutated Metastatic Castration-Resistant Prostate Cancer Open
Summary of exposure and safety data for safety population (treated patients with BRCAm) of MAGNITUDE
View article: Data from FDA Approval Summary: Niraparib plus Abiraterone Acetate Fixed-Dose Combination for <i>BRCA</i>-Mutated Metastatic Castration-Resistant Prostate Cancer
Data from FDA Approval Summary: Niraparib plus Abiraterone Acetate Fixed-Dose Combination for <i>BRCA</i>-Mutated Metastatic Castration-Resistant Prostate Cancer Open
On August 11, 2023, the FDA approved the fixed-dose combination of niraparib and abiraterone acetate (AA), with prednisone (AAP), for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCA
View article: FDA Approval Summary: Nogapendekin Alfa Inbakicept-pmln with BCG for BCG-Unresponsive Carcinoma <i>In Situ</i>
FDA Approval Summary: Nogapendekin Alfa Inbakicept-pmln with BCG for BCG-Unresponsive Carcinoma <i>In Situ</i> Open
On April 22, 2024, the U.S. FDA granted regular approval to nogapendekin alfa inbakicept-pmln (N-803) with Bacillus Calmette-Guerin (BCG) for the treatment of adult patients with BCG-unresponsive non–muscle-invasive bladder cancer with car…
View article: FDA Approval Summary: Niraparib plus Abiraterone Acetate Fixed-Dose Combination for <i>BRCA</i> -Mutated Metastatic Castration-Resistant Prostate Cancer
FDA Approval Summary: Niraparib plus Abiraterone Acetate Fixed-Dose Combination for <i>BRCA</i> -Mutated Metastatic Castration-Resistant Prostate Cancer Open
On August 11, 2023, the FDA approved the fixed-dose combination of niraparib and abiraterone acetate (AA), with prednisone (AAP), for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic…
View article: FDA Approval Summary: Repotrectinib for Locally Advanced or Metastatic ROS1-Positive Non–Small Cell Lung Cancer
FDA Approval Summary: Repotrectinib for Locally Advanced or Metastatic ROS1-Positive Non–Small Cell Lung Cancer Open
On November 15, 2023, the U.S. Food and Drug Administration (FDA) granted traditional approval to repotrectinib (Augtyro, Bristol Myers Squibb Corporation) for the treatment of adult patients with locally advanced or metastatic receptor ty…
View article: Measuring ovarian toxicity in clinical trials: an American Society of Clinical Oncology research statement
Measuring ovarian toxicity in clinical trials: an American Society of Clinical Oncology research statement Open
View article: FDA Approval Summary: Cabozantinib for Differentiated Thyroid Cancer
FDA Approval Summary: Cabozantinib for Differentiated Thyroid Cancer Open
On September 17, 2021, the FDA approved cabozantinib (Cabometyx; Exelixis, Inc.) for the treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has p…
View article: FDA Approval Summary: Margetuximab plus Chemotherapy for Advanced or Metastatic HER2-Positive Breast Cancer
FDA Approval Summary: Margetuximab plus Chemotherapy for Advanced or Metastatic HER2-Positive Breast Cancer Open
On December 16, 2020, the FDA granted regular approval to margetuximab-cmkb (MARGENZA), in combination with chemotherapy, for the treatment of adult patients with HER2-positive (HER2+) metastatic breast cancer who have received two or more…
View article: FDA Approval Summary: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer
FDA Approval Summary: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer Open
On June 15, 2020, the FDA granted accelerated approval to lurbinectedin for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. Approval was grante…
View article: Summary of a workshop on preclinical and translational safety assessment of CD3 bispecifics
Summary of a workshop on preclinical and translational safety assessment of CD3 bispecifics Open
Currently, there is a multitude of CD3 bispecifics with different molecular designs and binding properties in preclinical and clinical development for the treatment of liquid or solid tumors. The key safety concerns with CD3 bispecifics ar…