Noted This Week
The FDA approved the JAK inhibitor fedratinib (Inrebic; Celgene) in intermediate- and high-risk myelofibrosis. The approval was based on the phase III JAKARTA trial, in which 37% of patients treated with the drug had at least a 35% reduction in spleen volume, and 40% experienced at least a 50% reduction in disease-related symptoms, compared with 1% and 9%, respectively, in patients receiving a placebo. Fedratinib is the second JAK inhibitor and the second therapy for myelofibrosis to be approved.
The U.S. Preventive Services Task Force released a final statement recommending risk-assessment screening in women who have a personal or family history of breast, ovarian, tubal, or peritoneal cancer or ancestry associated with BRCA1/2 mutations, to determine their likelihood of carrying harmful BRCA1/2 mutations. The recommendation is similar to one published in 2013, but it expands the group that should undergo risk-assessment screening to include women who have completed treatment for breast, ovarian, tubal, or peritoneal cancer and are cancer free, as well as women of certain ancestries.
The U.S. Court of Appeals for the Federal Circuit declined to stop the sale of bevacizumab-awwb (Mvasi; Amgen/Allergan), a biosimilar of the angiogenesis inhibitor bevacizumab (Avastin; Genentech). The decision came in response to Genentech’s injunction claiming that Amgen should be required to wait longer to market the biosimilar after adding supplemental information to its original FDA application. Bevacizumab-awwb costs about 12% less than bevacizumab.
AstraZeneca announced that durvalumab (Imfinzi) plus tremelimumab may not be effective in treating non–small cell lung cancer. In the phase III NEPTUNE trial of newly diagnosed patients with a tumor mutation burden of at least 20 mutations per megabase, the PD-L1 inhibitor/CTLA4 inhibitor combination did not improve overall survival in patients with metastatic disease compared with standard chemotherapy.
NuCana will halt enrollment of a trial testing NIC-1031 (Acelarin) in metastatic pancreatic cancer based on a recommendation from an independent data-monitoring committee. The decision was made after the committee determined that the chemotherapeutic was unlikely to improve survival compared with gemcitabine in the phase III ACELERATE trial.
China’s National Healthcare Security Administration added 148 drugs to the list of medicines covered by its basic medical insurance plan. It also removed 150 drugs determined to have low clinical value or that could be replaced by more effective alternatives, bringing the total number on the list to 2,643 therapies. Additionally, 128 drugs that are efficacious but expensive have been identified as potential additions to the list, depending on the outcome of negotiations with the companies that make them.
In the United States, about 34,800 cancers per year could be attributed to human papillomavirus between 2012 to 2016, according to Morbidity and Mortality Weekly Report. In total, 92% of these HPV-related cancers were types targeted by the HPV vaccine. Another report indicated that in 2018, 51.1% of adolescents ages 13 to 17 had completed the HPV vaccine series, compared with 48.6% in 2017—an increase due entirely to more boys being vaccinated.