Top stories in hematology/oncology: FDA approves DNA-based assay, panel backs biosimilar for lymphoma
Among the most-read stories in hematology/oncology this week were reports that the FDA approved a DNA-based assay for blood transfusion compatibility and that an agency panel unanimously supported a Rituxan biosimilar for lymphoma.
Other popular stories included a report that discussed how the benefits of vitamin D in patients with cancer are inconclusive, an announcement that an immunotherapy developer was putting its leukemia and lymphoma trials on hold and a study that concluded that CAR T-cell therapy seemed cost-effective in treating patients with pediatric leukemia. – by Janel Miller
FDA approves DNA-based assay for blood transfusion compatibility
The FDA approved ID CORE XT, a molecular-based assay, to be used to determine blood compatibility prior to blood transfusions. Read more.
FDA panel unanimously backs Rituxan biosimilar for lymphoma
The FDA’s Oncologic Drugs Advisory Committee voted 16-0 to support the licensure of CT-P10 as a rituximab biosimilar for three non-Hodgkin lymphoma indications sought by the agent’s manufacturer. Read more.
Despite potential, data on vitamin D’s benefits for cancer remain inconclusive
Researchers have long sought to determine whether vitamin D has a true protective effect against cancer. Read more.
Affimed places leukemia, lymphoma trials on hold after patient death
Immunotherapy developer Affimed N.V. announced it has placed two trials for a T cell-engaging drug on clinical hold following three serious adverse events, including one patient death. Read more.
CAR T-cell therapy appears cost-effective in pediatric leukemia
Tisagenlecleucel appears to be priced in line with its estimated long-term survival benefit among children and young adults with relapsed or refractory B-cell acute lymphoblastic leukemia, according to results of a cost-effectiveness analysis published in JAMA Pediatrics. Read more.