Clinical

The FDA has launched a new pilot program that will evaluate whether disclosing certain information within clinical study reports following approval of a new drug application enhances public access to drug approval information, according to a statement by FDA Commissioner Scott Gottlieb, MD. The agency is also working to add a trial's ClinicalTrials.gov identifier number to the agency’s materials for future drug approvals.

Poor baseline Lung Immune Prognistic Index (combining derived neutrophils ratio greater than 3 and lactate dehydrogenase greater than upper limit of normal), or LIPI, was associated with worse outcomes for immune checkpoint inhibitor (ICI) treatment in patients with non-small cell lung cancer (NSCLC), but not with results of chemotherapy, according to a study in JAMA Oncology.

The trial evaluates the immunotherapy drug durvalumab as maintenance therapy in patients who have successfully undergone R0/R1 resection of pancreatic ductal adenocarcinoma following neoadjuvant chemotherapy and completion of adjuvant chemotherapy.

Regardless of daily exercise and healthy eating, a person’s genes determine their ability to lose or gain weight, and researchers have now identified 14 variations in 13 genes that affect an individual’s body mass index.

The approval expands the use of olaparib to include the treatment of patients with BRCA-mutated HER2-negative metastatic breast cancer. The FDA also expanded the approval of Myriad’s BRCAnalysis CDx, a companion diagnostic to olaparib, to include the detection of BRCA mutations.

More than half of octogenarians and nonagenarians with stage III non–small-cell lung cancer did not receive treatment, according to a study in CANCER. Older age, black race, and living in a lower educated census tract were found to be risk factors for not receiving treatment.

Syapse, a leading precision medicine company, and Roche have joined forces to advance precision medicine in oncology. They will work together to bring real-world data to providers, bring oncology into the value-based care era, advance patient-reported outcomes, and optimize clinical trial recruiment.

Eisai’s multiple receptor tyrosine kinase inhibitor lenvatinib and Merck’s anti–PD-1 therapy pembrolizumab as a combination therapy for patients with renal cell carcinoma received the designation based on results from the renal cell carcinoma cohort in Study 111.

While public funding through the National Institutes of Health has created a foundation for healthcare research, the private sector can benefit from getting more involved, said Bill Gates, philanthropist and co-founder of Microsoft.

Despite recent setbacks, drug makers and investors are still optimistic about finding an Alzheimer disease treatment; the United States' already moderately severe flu season could get worse; a charity that assists patients with out-of-pocket drug costs is suing the government over communication restrictions with drug donors.

A new guideline from the American Psychiatric Association to treat alcohol use disorder focuses on the use of evidence-based pharmacological treatments.

A subset of patients with chronic lymphocytic leukemia (CLL) with highly expressed CD49d have poorer outcomes while on Bruton’s tyrosine kinase (BTK) inhibitor ibrutinib, which antagonizes B-cell receptor (BCR) signals. However, a team of researchers may have found a way to treat these patients.

The fact that you have certain drugs that treat numerous cancers, and that they may treat 1 cancer different or better than another, would suggest that we should probably have differential pricing models, said A. Mark Fendrick, MD, director of the Center for Value-Based Insurance Design at the University of Michigan.

This week, the top managed care stories included an analysis of how healthcare spending has changed in the United States; a study finds people willing to try e-cigarettes smoke less and are more likely to quit; and a new cholesterol test that doesn't require fasting gives more accurate results.

Carfilzomib was associated with higher rates of all-grade and high-grade cardiovascular adverse events (CVAE), and both later trial phase and higher doses of carfilzomib were associated with higher rates of CVAE, according to a study in JAMA Oncology.

A newer method for calculating low-density lipoprotein (LDL) cholesterol is more accurate than the older method that required people fast before blood was drawn.

Patients with chronic obstructive pulmonary disease should be given the pneumococcal conjugate vaccine and influenza vaccines to decrease the risk of exacerbations. However, despite the evidence of vaccine efficacy, improvements are needed in coverage and awareness.

Using data collection means taking the guesswork out of treatment, said Torrie K. Fields, MPH, senior program manager of Palliative Care Program Design & Implementation for Blue Shield of California.

Every week, The American Journal of Managed Care® recaps the top managed care news of the week, and you can now listen to it on our podcast, Managed Care Cast.

Cost considerations and potential for prevention covered in current issue of Evidence-Based Diabetes ManagementTM.

Poll finds one-third of Americans believe the Affordable Care Act has been repealed; enrollees in Obamacare coverage largely come from states that voted for President Donald Trump; 2 trials find Zika vaccines are safe and effective.

Checkpoint inhibitors, compared with docetaxel, are associated with significantly prolonged overall survival in second and later lines of treatment for advanced non–small cell lung cancer, according to study findings published in JAMA Oncology.

After 14 weeks of treatment, both once-daily doses (15 mg and 30 mg) of upadacitinib met the study’s primary endpoints of low disease activity and ACR20 versus continuing methotrexate therapy.

Low medication adherence is a problem in healthcare, in general. However, adolescents with chronic health conditions also have low adherence, but they are at a critical age when they can create routines and health behaviors that optimize disease management as they become adults.

Community oncologists have a major role in accelerating treatment development and providing them to patients, said Amy Abernethy, MD, PhD, the chief medical officer, chief scientific officer, and senior vice president of oncology at Flatiron Health.