On May 24, 2019, the United States Food and Drug Administration (FDA) granted approval to the phosphoinositide 3-kinase (PI3K) inhibitor alpelisib for use in combination with fulvestrant for treatment of women and men with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2–) advanced breast cancer who carry PIK3CA mutations and have progressed on […]

Despite advances in cancer screening and detection, many cancers are not diagnosed until after they have metastasized. In patients with aggressive malignancies or severe comorbidities, survival can be limited. There has been relatively little information about treatment and outcomes in this population. To better understand treatment patterns in patients with poor prognosis, a study of […]

On May 13, 2019, the United States Food and Drug Administration (FDA) expanded the indication of the angiogenesis inhibitor ramucirumab to include use in patients with hepatocellular carcinoma (HCC) who have an alpha-fetoprotein (AFP) of greater than or equal to 400 ng/mL and have previously been treated with sorafenib. This decision was based on results […]

Immunotherapy with PD-1 and PD-L1 inhibitors has been a welcome addition to cancer treatment across numerous tumor types. While these agents are highly effective in some patients, they can be associated with severe, long-lasting adverse events (AEs). To better capture the incidence of AEs associated with PD-(L)1 inhibitors, a recent meta-analysis published in JAMA Oncology […]

At Aptitude Health, we strive to understand patterns of care that affect cancer patients not enrolled in clinical trials. We identify factors influencing prescribing habits that shape best practices and essentially get to the why. CASES Summits are regional events where approximately 60 oncologists and hematologists from large community practices along with leading scientific experts […]

On April 18, 2019, the United States Food and Drug Administration (FDA) issued a draft guidance for industry on the development of bispecific antibodies. This guidance outlines general considerations and recommendations for any new bispecific antibody development program, and also provides specific information regarding quality testing, nonclinical pharmacology and toxicology studies, clinical pharmacokinetic and pharmacodynamic […]