Erik Bloomquist
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View article: 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 Open
Background Retrospective analyses of studies of IO–containing combinations for advanced renal cell carcinoma (RCC) suggest that depth of response is associated with overall survival but have methodological limitations. We investigated the …
View article: Supplementary Table S2 from FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma
Supplementary Table S2 from FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma Open
Table S2 presents a summary of exposure and safety data by performance status in patients receiving combination treatment in EV-103
View article: Supplementary Table S3 from FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma
Supplementary Table S3 from FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma Open
Table S3 shows incidence of new peripheral neuropathy over time in patients receiving combination treatment in EV-103
View article: Supplementary Table S2 from FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma
Supplementary Table S2 from FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma Open
Table S2 presents a summary of exposure and safety data by performance status in patients receiving combination treatment in EV-103
View article: Supplementary Table S5 from FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma
Supplementary Table S5 from FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma Open
Table S5 shows the percentage of patients with resolution of neuropathy at last assessment of neuropathy in EV-103 and EV monotherapy pooled data
View article: Supplementary Figure S1 from FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma
Supplementary Figure S1 from FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma Open
Figure S1 is a schematic diagram of key datasets supporting the FDA’s efficacy review for accelerated approval of enfortumab vedotin plus pembrolizumab for cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer
View article: Supplementary Figure S1 from FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma
Supplementary Figure S1 from FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma Open
Figure S1 is a schematic diagram of key datasets supporting the FDA’s efficacy review for accelerated approval of enfortumab vedotin plus pembrolizumab for cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer
View article: Supplementary Table S1 from FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma
Supplementary Table S1 from FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma Open
Table S1 shows selected laboratory abnormalities ≥ 20 % (All Grades) in EV-103
View article: Supplementary Table S3 from FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma
Supplementary Table S3 from FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma Open
Table S3 shows incidence of new peripheral neuropathy over time in patients receiving combination treatment in EV-103
View article: Data from FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma
Data from FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma Open
On April 3, 2023, the FDA granted accelerated approval to enfortumab vedotin-ejfv (EV) plus pembrolizumab for treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemot…
View article: Supplementary Table S4 from FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma
Supplementary Table S4 from FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma Open
Table S4 shows incidence of new peripheral neuropathy over time in EV monotherapy pooled data
View article: Supplementary Figure S2 from FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma
Supplementary Figure S2 from FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma Open
Figure S2 is a schematic diagram of key datasets supporting the FDA’s safety review for accelerated approval of enfortumab vedotin plus pembrolizumab for cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer
View article: Supplementary Figure S2 from FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma
Supplementary Figure S2 from FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma Open
Figure S2 is a schematic diagram of key datasets supporting the FDA’s safety review for accelerated approval of enfortumab vedotin plus pembrolizumab for cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer
View article: Supplementary Table S4 from FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma
Supplementary Table S4 from FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma Open
Table S4 shows incidence of new peripheral neuropathy over time in EV monotherapy pooled data
View article: Supplementary Table S5 from FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma
Supplementary Table S5 from FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma Open
Table S5 shows the percentage of patients with resolution of neuropathy at last assessment of neuropathy in EV-103 and EV monotherapy pooled data
View article: Supplementary Table S1 from FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma
Supplementary Table S1 from FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma Open
Table S1 shows selected laboratory abnormalities ≥ 20 % (All Grades) in EV-103
View article: Data from FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma
Data from FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma Open
On April 3, 2023, the FDA granted accelerated approval to enfortumab vedotin-ejfv (EV) plus pembrolizumab for treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemot…
View article: US Food and Drug Administration Approval Summary: Talazoparib in Combination With Enzalutamide for Treatment of Patients With Homologous Recombination Repair Gene-Mutated Metastatic Castration-Resistant Prostate Cancer
US Food and Drug Administration Approval Summary: Talazoparib in Combination With Enzalutamide for Treatment of Patients With Homologous Recombination Repair Gene-Mutated Metastatic Castration-Resistant Prostate Cancer Open
PURPOSE The US Food and Drug Administration (FDA) approved talazoparib with enzalutamide for first-line treatment of patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). …
View article: FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma
FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma Open
On April 3, 2023, the FDA granted accelerated approval to enfortumab vedotin-ejfv (EV) plus pembrolizumab for treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemot…
View article: Advancing Clinical Trial Design for Non-Muscle Invasive Bladder Cancer
Advancing Clinical Trial Design for Non-Muscle Invasive Bladder Cancer Open
BACKGROUND: Despite recent drug development for non-muscle invasive bladder cancer (NMIBC), few therapies have been approved by the US Food and Drug Administration (FDA), and there remains an unmet clinical need. Bacillus Calmette-Guerin (…
View article: FDA Approval Summary: Ribociclib Indicated for Male Patients with Hormone Receptor–Positive, HER2-Negative Advanced or Metastatic Breast Cancer
FDA Approval Summary: Ribociclib Indicated for Male Patients with Hormone Receptor–Positive, HER2-Negative Advanced or Metastatic Breast Cancer Open
On December 10, 2021, the FDA expanded the indications for ribociclib to include male patients for the treatment of hormone receptor–positive, HER2-negative advanced or metastatic breast cancer. Ribociclib is now indicated in combination w…
View article: A U.S. Food and Drug Administration–pooled Analysis of Frontline Combination Treatment Survival Benefits by Risk Groups in Metastatic Renal Cell Carcinoma
A U.S. Food and Drug Administration–pooled Analysis of Frontline Combination Treatment Survival Benefits by Risk Groups in Metastatic Renal Cell Carcinoma Open
Patients with intermediate/poor-risk metastatic renal cell carcinoma derive an overall survival benefit from immuno-oncology/tyrosine kinase inhibitor combinations, while data for favorable-risk remain immature.
View article: Regulatory implications of ctDNA in immuno-oncology for solid tumors
Regulatory implications of ctDNA in immuno-oncology for solid tumors Open
In the era of precision oncology, use of circulating tumor DNA (ctDNA) is emerging as a minimally invasive approach for the diagnosis and management of patients with cancer and as an enrichment tool in clinical trials. In recent years, the…
View article: FDA Approval Summary: Belzutifan for von Hippel-Lindau Disease–Associated Tumors
FDA Approval Summary: Belzutifan for von Hippel-Lindau Disease–Associated Tumors Open
On August 13, 2021, the FDA approved belzutifan (WELIREG, Merck), a first-in-class hypoxia-inducible factor (HIF) inhibitor for adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RC…
View article: U.S. FDA Drug Approvals for Breast Cancer: A Decade in Review
U.S. FDA Drug Approvals for Breast Cancer: A Decade in Review Open
Over the last decade, the treatment of patients with breast cancer has been greatly impacted by the approval of multiple drugs and indications. This summary describes 30 FDA approvals of treatments for breast cancer from 2010 to 2020. The …
View article: U.S. FDA Drug Approvals for Gynecological Malignancies: A Decade in Review
U.S. FDA Drug Approvals for Gynecological Malignancies: A Decade in Review Open
Over the last decade, there has been tremendous progress in the treatment of patients with gynecologic cancers with a changing therapy landscape. This summary provides an overview of U.S. Food and Drug Administration (FDA) approvals for gy…
View article: Subgroup Analyses in Oncology Trials: Regulatory Considerations and Case Examples
Subgroup Analyses in Oncology Trials: Regulatory Considerations and Case Examples Open
Subgroup analyses are assessments of treatment effects based on certain patient characteristics out of the total study population and are important for interpretation of pivotal oncology trials. However, appropriate use of subgroup analyse…
View article: Report of National Brain Tumor Society roundtable workshop on innovating brain tumor clinical trials: building on lessons learned from COVID-19 experience
Report of National Brain Tumor Society roundtable workshop on innovating brain tumor clinical trials: building on lessons learned from COVID-19 experience Open
On July 24, 2020, a workshop sponsored by the National Brain Tumor Society was held on innovating brain tumor clinical trials based on lessons learned from the COVID-19 experience. Various stakeholders from the brain tumor community partic…
View article: Overall Survival in Patients with Hormone Receptor-Positive, HER2-Negative Advanced or Metastatic Breast Cancer Treated with a CDK 4/6 Inhibitor Plus Fulvestrant: A U.S. Food and Drug Administration Pooled Analysis
Overall Survival in Patients with Hormone Receptor-Positive, HER2-Negative Advanced or Metastatic Breast Cancer Treated with a CDK 4/6 Inhibitor Plus Fulvestrant: A U.S. Food and Drug Administration Pooled Analysis Open
View article: FDA Approval Summary: Rucaparib for the Treatment of Patients with Deleterious <i>BRCA</i>-Mutated Metastatic Castrate-Resistant Prostate Cancer
FDA Approval Summary: Rucaparib for the Treatment of Patients with Deleterious <i>BRCA</i>-Mutated Metastatic Castrate-Resistant Prostate Cancer Open
The U.S. Food and Drug Administration (FDA) granted accelerated approval to rucaparib in May 2020 for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic)-associated metastatic castrate-resistant prostat…