FDA approved Roche’s VENTANA PD-L1 (SP263) assay as a companion diagnostic to identify non-small cell lung cancer patients eligible for treatment with Libtayo (cemiplimab), based on the results of the Phase III EMPOWER-Lung study.
FDA approved a single-dose, prefilled autoinjector presentation of Udenyca (pegfilgrastim-cbqv), a biosimilar pegfilgrastim administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia. The Udenyca autoinjector has a streamlined, easy-to-use design for use in both in-office and at-home settings of care.
FDA published updates to the mammography regulations to, among other things, require mammography facilities to notify patients about the density of their breasts, strengthen the FDA’s oversight and enforcement of facilities and help interpreting physicians better categorize and assess mammograms.
FDA’s Center for Tobacco Products published the actions it plans to take in response to an external evaluation commissioned last year from an independent panel of evaluators working through the Reagan-Udall Foundation.
Can a single drug replace a long-established curative, albeit brutal, regimen of chemotherapy, radiation, and surgery?
Cancer specialists like me, whether they are medical, surgical, or radiation oncologists spend our lives treating life threatening disease. We generally have a serious and professional demeanor reflective of the world that we choose to inhabit and the circumstances facing our patients that entrust us with their care.
NCI is increasing the R01 payline to the 12th percentile in fiscal year 2023, up from the 11th percentile in FY22—bringing the institute’s payline to a level not seen since 2010.
President Joe Biden mentioned cancer 13 times in his impassioned State of the Union address and placed cancer research at the top of his Unity Agenda—an indication that his administration would continue to prioritize funding for cancer research in fiscal year 2024.
FDA approved Jemperli (dostarlimab-gxly) for adult patients with mismatch repair deficient recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation.
Laleh Amiri-Kordestani was named acting associate director for cardio-oncology in the FDA Oncology Center of Excellence. She will also continue her role as the division director for the Division of Oncology 1.
