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Drug and diagnostic approvals and biosimilars news were popular with readers.
Online readers of Managed Healthcare Executive® interested in oncology looked for updates from FDA and news about biosimilars in 2020. The FDA Updates column, appearing on Sundays, became a popular feature during the second half of the year. Here are the most-read oncology news items for 2020:
5. More Action Is Sought to Prevent Continuous Rise of Childhood Cancer in U.S.
In October, the Max Cure Foundation called for scientists, policy makers, health advocates, businesses and parents to put more emphasis on prevention to stop the rise of childhood cancer in the United States. Steps such as reducing toxic chemicals and environmental damage are just as important as finding new treatments, the foundation said a statement. Such an approach would require across-the-board action from government to the consumer level, starting with increased investment in prevention research and an expansion of regulations to reduce known causes of cancer.
4. OneOncology Having Success With Mvasi, Kanjinti
OneOncology, the expanding partnership of community oncology practices based in Tennessee, decided to all-in for biosimilars and to advertise its success. In August, OneOncology CEO Jeffrey F. Patton, MD, spoke with Managed Healthcare Executive® about its use of a pair of Amgen biosmilars, Mvasi ((bevacizumab-awwb), and Kanjinti ((trastuzumab-anns), whose reference products are the widely used cancer therapies Avastin (bevacizumab) and Herceptin (trastuzumab). Patton said the switch from day one of availability of the products resulted in 15% savings, reducing therapeutic costs for patients, the public, and for commercial payers. Patton has been an advocate for giving community practices autonomy over selection of biosimilars so that that practices are not required to carry multiple biosimilar versions of the therapy, which can create administrative and storage issues.
3. Oncology Care Model Spurs Use of Biosimilar Filgrastim
Biosimilar versions of the filgrastim, a recombinant non-pegylated granulocyte colony-stimulating factor (GCSF), have proliferated in recent years, and their use has taken off since the launch of the Oncology Care Model. Evaluators from Abt Associates who studied the rise of biosimilar filgrastim found that while prescriptions rose in both OCM practices and a comparator group of practices not taking part in the alternative payment model, uptake of biosimilars was greater in the episodes of care delivered by the OCM practices between July 1, 2016, and December 31, 2017.
2. FDA Updates: Blood Cancers, Orphan Drug Designations Get Priority
A new Sunday feature in Managed Healthcare Executive® that lets readers get caught up on the week’s activity covered a busy week in late July as FDA approved the first new chimeric antigen receptor (CAR) T-cell therapy in nearly three years, when it approved Tecartus (brexucabtagene autoleucel) for refractory mantle cell lymphoma (MCL) has relapsed or not responded to treatment. FDA also approved a combination including Monjuvi (tafasitamab-cxix) for adults with diffuse large B-cell lymphoma who are not eligible for an autologous stem cell transplant.
1. FDA Updates: Assays Used in Cancer Care Get Green Light
In early August, Adaptive Biotechnologies’ clonoSEQ received its third approval—to detect minimal residual disease (MRD) in in chronic lymphocytic leukemia (CLL). The assay uses a proprietary immunosequencing platform to detect MRD, in which a small number of cancer cells can remain after treatment. Precise measurement tools are needed to detect MRD, which can lead to cancer recurrence. MRD has received increased attention as an endpoint in clinical trials in blood cancers. That same week, FDA also approved the Guardant360 CDx liquid biopsy for comprehensive genomic profiling, In non-oncology news, regulators approved Genentech’s Evrysdi (risdiplam), an oral treatment given at home for spinal muscular atrophy (SMA).