A5072533439- Bladder and Urothelial Cancer Treatments
- Renal cell carcinoma treatment
- Cancer Immunotherapy and Biomarkers
- Cancer Genomics and Diagnostics
- Multiple and Secondary Primary Cancers
- Urinary and Genital Oncology Studies
- Economic and Financial Impacts of Cancer
- Prostate Cancer Treatment and Research
- Scoliosis diagnosis and treatment
- Renal and related cancers
- Spinal Fractures and Fixation Techniques
- Health Systems, Economic Evaluations, Quality of Life
- Radiomics and Machine Learning in Medical Imaging
- Radiopharmaceutical Chemistry and Applications
- Pelvic and Acetabular Injuries
- Statistical Methods in Clinical Trials
- Pain Management and Opioid Use
- Colorectal Cancer Treatments and Studies
- Management of metastatic bone disease
- PARP inhibition in cancer therapy
- MRI in cancer diagnosis
- Cancer Treatment and Pharmacology
- Lung Cancer Treatments and Mutations
- Inflammatory Biomarkers in Disease Prognosis
- Mathematical Biology Tumor Growth
United States Food and Drug Administration
2018-2024
Center for Drug Evaluation and Research
2018-2024
Food and Drug Administration
2022
MedStar Health
2020-2021
Addenbrooke's Hospital
2021
MedStar Washington Hospital Center
2015
Washington Hospital
2014
Stanford Medicine
2012
Stanford University
2012
Texas Scottish Rite Hospital for Children
2008-2010
Abstract The U.S. Food and Drug Administration (FDA) granted accelerated approval to atezolizumab pembrolizumab in April May 2017, respectively, for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible cisplatin-containing chemotherapy. These approvals were based on efficacy safety data demonstrated two single-arm trials, IMvigor210 (atezolizumab) KEYNOTE-052 (pembrolizumab). primary endpoint, confirmed objective response rate, was 23.5%...
On March 23, 2022, the FDA approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan, also known as 177Lu-PSMA-617) for treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated androgen receptor pathway inhibition and taxane-based chemotherapy. The recommended 177Lu-PSMA-617 dose is 7.4 gigabecquerels (GBq; 200 mCi) intravenously every 6 weeks up to six doses, or until disease progression...
We performed a pooled analysis of multiple trials poly(ADP-ribose) polymerase inhibitors (PARPi) in metastatic castration-resistant prostate cancer (mCRPC) to investigate the efficacy PARPi each individual homologous recombination repair (HRR) mutated (m) gene.
Single-arm trials have allowed for transformative therapies to be made available patients expeditiously. However, using single-arm support drug approval presents several challenges that must carefully considered.Between January 1, 2002, and December 31, 2021, the US Food Drug Administration granted 176 new malignant hematology oncology indications based on trials, including 116 accelerated approvals (AAs) 60 traditional approvals. Overall, 87 (49%) were molecular entities or original...
A retrospective review comparing patients who had postoperative ketorolac and those did not following posterior spinal fusion instrumentation (PSFI) for adolescent idiopathic scoliosis (AIS).To analyze the effect of on incidence pseudoarthrosis in AIS patients.Ketorolac (Toradol, Roche Laboratories, Nutley, NJ) is a nonsteroidal antiinflammatory drug that an effective adjunct to manage pain. It has been previously demonstrated inhibit adult undergoing L4 sacral fusion. To our knowledge,...
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 cisplatin-containing chemotherapy. Substantial evidence effectiveness was obtained from EV-103/KEYNOTE-869 (NCT03288545), a multicohort study. Across cohorts, total 121 received EV 1.25 mg/kg (maximum 125 mg) intravenously on days 1 and 8 21-day cycle 200 mg day each until disease...
This pooled analysis of patient-level data from trials evaluated the clinical outcomes patients with metastatic renal cell carcinoma or without cytoreductive nephrectomy before a combination immune checkpoint inhibitor and antiangiogenic therapy.
In Brief Study Design. Multicenter analysis of 3 groups patients who underwent surgical treatment for adolescent idiopathic scoliosis (AIS). Objective. To evaluate approaches to determine the modality that has greatest influence on improving thoracic kyphosis. Summary Background Data. AIS is characterized by hypokyphosis which may be restored normal varying degrees with surgery. Methods. A multicenter retrospective database was reviewed. Patients only a structural main curve (Lenke 1, 2, or...
In developmental dysplasia, Pavlik harness treatment of hips with a positive Ortolani sign fails in up to 40% such patients; however, no study has described factors for failure associated ultrasonographic parameters. The goal this was describe unique markers that are failure.A retrospective review performed all patients less than six months old who were treated dysplasia the hip from 1991 2005 at single institution. Inclusion criteria dislocated but reducible (a sign), harness, and an...
Abstract Purpose: A clinically meaningful attribute of some immune-oncology (IO) regimens is potential durable clinical benefit during a treatment-free interval. We characterize survival (TFS) with and without ongoing toxicity in trials frontline IO-VEGF tyrosine kinase inhibitor (TKI) combinations patients advanced renal cell carcinoma (aRCC). Experimental Design: Individual patient data were pooled by treatment arm from randomized submitted to the FDA evaluating IO-TKI combination...
Despite recent drug development for non-muscle invasive bladder cancer (NMIBC), few therapies have been approved by the US Food and Drug Administration (FDA), there remains an unmet clinical need. Bacillus Calmette-Guerin (BCG) supply issues underscore importance of developing safe effective drugs NMIBC.
To harmonize the eligibility criteria and radiologic disease assessment definitions in clinical trials of adjuvant therapy for renal cell carcinoma (RCC).On November 28, 2017, US-based experts RCC trials, including medical oncologists, urologic regulators, biostatisticians, radiologists, patient advocates, convened at a public workshop to discuss trial entry assessing recurrence RCC. Multiple virtual meetings were conducted address issues identified workshop.The key conclusions as follows....
Appropriate cancer pain documentation is one of the quality measures in American Society Clinical Oncology (ASCO) Quality Practice Initiative (QOPI). MedStar Washington Cancer Institute has participated QOPI since 2008, and documenting a plan care for moderate to severe (which was defined as score ≥ 4 on scale 0 10, with 10 being worst) identified an area improvement.We undertook structured approach improve moderate/severe support from ASCO's Training Program. Our team used standard...
FDA Oncology Center's @Falleh_Fallah and colleagues discuss loss of equipoise other trial conduct challenges in an era breakthrough therapies - via @JCO_ASCO.
To harmonize eligibility criteria and radiographic disease assessments in clinical trials of adjuvant therapy for muscle-invasive bladder cancer (MIBC).National experts trial research, including medical urologic oncologists, radiologists, biostatisticians, patient advocates, convened at a public workshop on November 28, 2017, to discuss eligibility, entry criteria, assessment recurrence patients with MIBC.The key conclusions MIBC included the following points: (1) urothelial carcinoma...
4559 Background: The International Metastatic RCC Database Consortium (IMDC) risk model was developed for prognosis of patients with mRCC treated vascular endothelial growth factor (VEGF)-targeted monotherapy in the first-line setting. Efficacy trials anti-VEGF therapy has been generally consistent across groups, including overall survival (OS). For immunotherapy combinations, small numbers OS events favorable group each trial limited reliable conclusions; however, there a suggestion...
Abstract The FDA conducts independent reviews of scientific data obtained with investigational drug products to ensure that they are safe and effective. As a result this process, FDA-approved product labeling is generated considered one the most trusted sources information for use an approved drug. But approval only beginning life cycle new drug; first oncology drugs now have more than 7 decades clinical experience in postmarketing setting. Due, part, lack incentives, some companies may not...
The development and review of combination drug regimens in oncology may present unique challenges to investigators regulators. For regulatory approval regimens, it is necessary demonstrate the contribution effect each monotherapy overall combination. Alternative approaches traditional designs be needed accelerate development, for example, when combinations are substantially superior available therapy, reduce exposure less effective therapies, drugs that inactive as single agents potentiate...