Amid an ongoing investigation of CAR T-cell therapy safety, the FDA has added risk of secondary malignancies to the boxed warning for ciltacabtagene autoleucel (Carvykti). (Fierce Pharma)
Cellular and gene therapy will likely have the biggest impact on the pharmaceutical industry in the coming year. (GlobalData)
Bipartisan legislation introduced in the House aims to close a Nuclear Regulatory Commission loophole to improve patient safety of nuclear medicine diagnostic tests in oncology and cardiology. (Patients for Safer Nuclear Medicine)
A liquid biopsy that measures circulating tumor DNA showed promise as a potential test to identify patients whose lung cancer is likely to respond to immunotherapy. (Johns Hopkins Medicine)
A saliva test to evaluate changes in sugar molecules could help identify cancer cells in early stages of evolution. (University of Gothenburg, Cell Reports Methods)
The combination of dostarlimab (Jemperli) and niraparib (Zejula) significantly improved progression-free survival in a randomized trial of advanced/recurrent endometrial cancer, according to a statement from GSK.
A cancer researcher’s own diagnosis of male breast cancer provided the impetus for groundbreaking studies of new strategies to improve treatment. (University of Utah Huntsman Cancer Institute)
Fewer than half of patients with an aggressive form of urinary tract cancer received palliative care. (Urology Practice)
Mailing a letter and a signed order for ultrasound significantly increased the rate of screening for liver cancer in high-risk patients. (Hepatology Communications)
The FDA declined to grant full approval to sotorasib (Lumakras) for KRAS-mutated non-small cell lung cancer and requested a new confirmatory clinical trial, according to a statement from Amgen.
Meanwhile, Coherus BioSciences announced that the agency approved an on-body injector for its pegfilgrastim biosimilar (Udenyca) to reduce the risk of infection, as manifested by febrile neutropenia, following chemotherapy.
The coming year could prove to be pivotal for determining the impact of Medicare drug-price negotiations and the legal challenges by drug companies. (CNBC)
In laboratory studies, a “molecular jackhammer” wiped out 99% of melanoma cells growing in dish. (Rice University)