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Gilteritinib (Xospata), a recently approved FLT3 inhibitor, prolonged survival in patients with relapsed or refractory acute myeloid leukemia (AML) and an FLT3 mutation in the phase 3 ADMIRAL clinical trial. A new analysis presented at ASCO 2019 was focused on the impact of baseline co-mutations and FLT3-ITD allelic burden on overall response and on overall survival (OS) in patients with relapsed or refractory AML who received treatment with gilteritinib.

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On July 30, 2019, the FDA approved darolutamide (Nubeqa; Bayer) for the treatment of patients with nonmetastatic castration-resistant prostate cancer.

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On August 15, 2019, the FDA granted accelerated approval to entrectinib (Rozlytrek; Genentech) for the treatment of patients aged ≥12 years with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation; are metastatic or where surgical resection is likely to result in severe morbidity; and have progressed after treatment or have no satisfactory standard therapy.

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Medical practices and hospital centers across the United States are facing important choices that will determine their fiscal and physical viability moving into 2020. Not only is the impetus behind these required changes unclear, many feel that there is a lack of purpose and justification for them, which has resulted in mounting frustration. Read More ›

Results from a new clinical trial suggest that limited access to care is the main contributing factor to the disparities in outcomes that exist between African-American patients and white patients with cancer. Read More ›

With 475 cell and gene therapy companies in North America representing a business enterprise with approximately $20 billion, new immunotherapies are moving rapidly from the laboratory to the clinic. As chimeric antigen receptor (CAR) T-cell therapy makes its way from the academic to the community setting, however, appropriate resources and infrastructure are required to ensure the safe and effective management of patients. Read More ›

Although clinical trials are essential for evaluating novel therapies and determining the most effective treatment options for patients with cancer, participation in these trials remains low, especially among ethnic and racial minorities. At the 2019 American Society of Clinical Oncology Annual Meeting, Kessely Hong, PhD, MPA, Faculty Chair, MPA Programs, and Lecturer, Public Policy, Harvard Kennedy School, John F. Kennedy School of Government, Cambridge, MA, and Electra D. Paskett, PhD, Marion N. Rowley Professor of Cancer Research, Division of Cancer Prevention and Control, Department of Internal Medicine, College of Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, discussed strategies to enhance clinical trial enrollment and retention. Read More ›

The addition of the cyclin-dependent kinase (CDK)4/CDK6 inhibitor ribociclib to standard endocrine therapy significantly extended overall survival (OS) compared with endocrine therapy alone in premenopausal women with hormone receptor (HR)-positive, HER2-negative advanced breast cancer, according to results of the phase 3 MONALEESA-7 clinical trial, presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting. Read More ›

Genetic alterations in molecular pathways are involved in tumor development, survival, and progression. Precision cancer medicine is about using the cancer genome to guide treatment decisions, according to Christine M. Walko, PharmD, BCOP, Personalized Medicine Pharmacologist, Personalized Medicine Clinical Service, and Chair, Clinical Genomic Action Committee, Moffitt Cancer Center, Tampa, FL. Read More ›

In the phase 3 CLL14 clinical trial, fixed-duration venetoclax plus obinutuzumab was superior to chlorambucil plus obinutuzumab as front-line therapy in older patients with chronic lymphocytic leukemia (CLL) and comorbidities. The fixed-duration regimen significantly improved progression-free survival (PFS), complete response (CR) rate, and minimal residual disease (MRD) negativity versus chlorambucil plus obinutuzumab, and was superior in patients with poor prognostic factors, such as unmutated IGHV and TP53 alterations. Read More ›