Clinical

The FDA is giving serious consideration to the economics of the drug or device development process, and to that effect, has released a draft guidance for manufacturers on how and what to communicate with payers and formulary committees.

The improved expansion of chimeric antigen receptor (CAR) T-cells indicates a deeper clinical response.

A new report released by the American Cancer Society indicates that while the cancer-related death rate was higher among blacks than in whites in 2014, the racial gap could reduce as minority patients increasingly gain access to insurance and subsequent healthcare.

The abortion rate in the United States hit a historic low in 2014 with 2 likely contributing factors: improved access to contraceptives and increased restrictions to abortion services.

Despite the complexities associated with treating older patients diagnosed with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), patients in the RESONATE-2 trial continue to present a favorable response to single-agent ibrutinib at a follow-up of 29 months.

The results showed that obinutuzumab-based immunochemotherapy and maintenance improved progression-free survival in treatment-naïve patients with follicular lymphoma.

A study in a mouse model found that mice receiving chimeric antigen receptor (CAR)-T immunotherapy plus ibrutinib demonstrated longer overall survival and reduced cytokine production than the mice not treated with ibrutinib.

A novel, simplified cost-value analysis tool was created to better differentiate the value of anticancer agents and further characterize the expected survival benefit of all patients.

The trial, evaluating the programmed death ligand-1 inhibitor durvalumab, alone or in combination with tremelimumab, versus platinum-based chemotherapy, has refined its endpoints to include overall survival (OS) along with progression-free survival.

Among the 9 new orphan drugs approved by the FDA in 2016 were 3 treatments for rare diseases that, so far, had no approved treatments: Duchenne muscular dystrophy, spinal muscular atrophy, and severe hepatic veno-occlusive disease.

According to a new study, in addition to tumor type, stage, and the presence of comorbidities, patients receiving cisplatin-based treatments might be at an increased risk of venous thromboembolism.

At the 58th American Society of Hematology Annual Meeting & Exposition, Jan Joseph Melenhorst, PhD, presented results of a study evaluating biomarkers of response to anti-CD19 CAR T-cell treatment in patients diagnosed with chronic lymphocytic leukemia (CLL).

Phase 3 results from the LyMa trial have shown that rituximab, after autologous stem cell transplant (ASCT), prolongs event-free survival, progression-free survival, and overall survival (OS) in previously untreated young patients with mantle cell lymphoma (MCL) following ASCT.

Early phase 1 results show that including the cyclin-dependent kinase 4/6 inhibitor palbociclib in the treatment plan of patients with mantle cell lymphoma can help overcome resistance to ibrutinib.

In high-risk patients with chronic lymphocytic leukemia (CLL), CD19 chimeric antigen receptor (CAR)-T cells of defined composition can be administered with an acceptable early toxicity.

An experiment by Park Nicollet Health Services to document personalized pain management goals for patients in oncology clinics lowered documented pain, while physician education on cost information helped reduce treatment costs.

Since patients with COPD often have other comorbidities, researchers sought to understand patient adherence to maintenance COPD medications and adherence to treat other chronic conditions.

A new initiative has been launched at the University of North Carolina to create and share tools to fight rare diseases.

Research published in the Journal of Oncology Practice has identified high treatment burden among Medicare patients with early-stage non—small cell lung cancer (NSCLC).

A conglomerate of 69 National Cancer Institute—designated cancer centers has come together to endorse the CDC’s recommendations for HPV vaccination of young children.

Described as a public—private partnership between the National Cancer Institute (NCI) and pharmaceutical and biotechnology companies, the NCI Formulary is expected to provide researchers rapid access to anticancer drugs for use in clinical trials.

A screening study conducted over 2 decades in Denmark has raised questions about the need and implications of biennial mammography for women between 50 and 69 years of age.

Researchers from the Memorial Sloan Kettering Cancer Center have developed a novel method using modified donor T cells to make stem cell transplants both safer and more effective for treating blood cancers

What we're reading: the Obama administration promises swift action on North Carolina's Medicaid expansion plan; FDA approves long-acting opioid; and a look at where President Barack Obama and President-elect Donald J. Trump stand on 5 areas of health policy and science.

The study observed significant shifts in the treatment of advanced-stage non-small cell lung cancer (NSCLC), accompanied by only modest gains in survival and total Medicare spending.