Tony Berberabe, MPH

An overview of the regulatory activities of the Office of Oncology Drug Products and the Office of Hematology and Oncology Drug Products from 2008 to 2016 suggests that the FDA has made consistent use of regulatory mechanisms to expedite approvals during that period. Investigators from the Office of Biostatistics, Center for Drug Evaluation and Research completed an analysis to determine if changes in the laws, regulations, and the agency that occurred after 2007 had an effect on regulatory approvals.

Findings from a recent study have suggested that wearable activity monitors could potentially replace performance status and functionability assessments going forward. This could lead to more accurate PS scores as evaluations of PS are difficult to determine objectively in the clinic. 

A meta-analysis and systemic review specifically assessing carfilzomib-associated cardiovascular adverse events suggests an elevated risk in patients with multiple myeloma who are taking the proteasome inhibitor.

Using next-generation squencing methods, researchers are attempting to combine clinical and genomic biomarkers to identify patients with smoldering multiple myeloma who are at high risk for disease progression.

Regardless of smoking history, patients with cancer of the lung harboring specific genetic alterations who were treated with targeted therapies experienced longer survival than those patients who did not receive targeted treatment, according to results of a multi-institutional extension study to identify and treat oncogenic driver events.

An extension in overall survival (OS) with the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) has completely changed the standard of care for patients with metastatic renal cell carcinoma (mRCC), Thomas Powles, MD, MBBS, MRCP, told audience members during the 9th European Multidisciplinary Meeting on Urological Cancers.<br /> &nbsp;

A new study published in the August 7 issue of <em>Nature</em> identified genes that are necessary in cancer cells for immunotherapy to work, addressing the problem of why some tumors do not respond to immunotherapy or respond initially but then stop as tumor cells develop resistance to immunotherapy.

Four tumor serum markers commonly used in other solid tumors could be used in monitoring therapeutic outcomes in patients with stage IV lung adenocarcinoma, according to a single-center retrospective analysis.

About 71% of patients (17 of 24) with chronic lymphocytic leukemia exhibited an overall response (complete and/ or partial response) 4 weeks after receiving CAR T cell infusion therapy.

Patients with metastatic papillary renal cell carcinoma have limited therapeutic options, but results of a phase II safety and efficacy study suggest that a small-molecule inhibitor, savolitinib, could help patients with MET-driven disease.

Results from the phase I portion of the first trial testing axicabtagene ciloleucel, an autologous CD3&zeta;/CD28-based CAR T-cell therapy, indicate that the regimen can safely be administered and lead to durable CR after more than 12 months in refractory diffuse large B-cell lymphoma.

Results of an initial study of tumors from patients with lung cancer or head and neck cancer suggest that acquired resistance to checkpoint inhibitors may be due to the elimination of certain genetic mutations needed to enable the immune system to recognize and attack malignant cells.

Measuring molecular biomarkers after metastasis could inform treatment decisions for women with breast cancer that has spread to the brain.

Howard L. Kaufman, MD, FACS discusses the abstracts chosen for presentation during the Presidential Session of the SITC 31st Annual Meeting and Associated Programs.&nbsp;

Study results that examined patient-reported outcomes and quality of life measures demonstrate that hypofractionated radiotherapy (H-RT) is a viable, safe, and value-added alternative to patients with low-risk prostate cancer.

For patients who are likely to experience contiguous recurrence of glioblastoma, a new computer simulation using tumor treating fields (TTF) and employing a personalized transducer array, delivered electric field (EF) intensities that exceeded therapeutic intensities in 3 different tumor locations.

Results from a phase II study from Korea demonstrated high rates of tumor local control, overall survival (OS), and grade 1/2 gastrointestinal and hepatic toxicities in patients who received stereotactic body radiotherapy (SBRT) for unresectable hepatocellular carcinoma (HCC) after incomplete transarterial chemoembolization (TACE).

Jim Zhong, MD, and colleagues describe a National Cancer Database (NCDB) outcomes analysis of patients with muscle invasive bladder cancer treated with either radical surgery or bladder preservation therapy.

Patients with renal cancer who underwent cytoreductive nephrectomy (CN) and targeted therapy (TT) had improved survival compared with patients who did not undergo the surgery, according to research from the Dana-Farber Cancer Institute and Brigham and Women&rsquo;s Hospital.¹&nbsp;Historically, only 3 in 10 such patients undergo the procedure.

The pivotal phase III prostate cancer trial ARMO 3-SV will be discontinued based on recommendations made by the trial&#39;s independent data monitoring committee.

The phase III ARMOR 3-SV trial for prostate cancer was not likely to meet its primary endpoint of radiographic progression-free survival (PFS) improvement, the trial&rsquo;s independent data monitoring committee (DMC) decided, leading to the trial&rsquo;s discontinuation, according to the manufacturer Tokai Pharmaceuticals.

A study of apalutamide (ARN-509) in patients with high-risk, localized, or locally advanced prostate cancer who are receiving primary radiation therapy is hoping to reduce the risk of metastasis and death from prostate cancer for these high-risk patients, according to the study&rsquo;s global principal investigator, Howard M. Sandler, MD.

Researchers are hoping the results of a latestage efficacy and safety study of apalutamide (ARN-509) in patients with high-risk, localized, or locally advanced prostate cancer who are receiving primary radiation therapy will demonstrate an improvement in metastasis-free survival, according to global principal investigator, Howard M. Sandler, MD.

The immunotherapy agent atezolizumab (Tecentriq) reduced the size of tumors by 24% in patients with metastatic urothelial carcinoma (mUC), according to phase II clinical trial results presented at the 2016 ASCO Annual Meeting.

Using the Decipher Prostate Cancer Classifier assay to predict which patients might respond to hormonal therapy has resulted in the discovery and validation of an adjuvant androgen-deprivation therapy resistance signature.

The amount of vitamin D in a man's blood could be an effective biomarker to identify an aggressive form of prostate cancer, doubly so for men who are considering active surveillance.

Men whose prostate cancer is treated with radiotherapy had a higher risk of developing secondary malignancies in the bladder, colon, and rectum, as compared with men who were not exposed to radiotherapy.

The FDA has accepted a supplemental new drug application for a capsulated form of enzalutamide for review in patients with metastatic castration-resistant prostate cancer. This application includes findings from the head-to-head studies, TERRAIN and STRIVE.

A current estimation shows that roughly 25% of metastatic castration-resistant prostate cancers (mCRPC) contain alterations in DNA repair genes. These would normally code for proteins to correct errors arising when cells duplicate their DNA before cell division.