Empowering the FDA to Require Dose Optimization of All New Oncology Drugs

"We have previously pointed out the multiple opportunities in oncology to reduce prescribing costs—and potentially adverse events as well—through development and implementation of off-label dosing regimens that utilize pharmacologically justified dosing, a concept we have called interventional pharmacoeconomics. However, there is also an opportunity for the U.S. Food and Drug Administration (FDA) to require that sponsors optimize dosing upfront, either before or soon after approval (ie, as a postmarketing requirement). Although the FDA has done so for several drugs, the vast majority of nonbiologic oncology drugs are developed and approved at their maximally tolerated dose, leading to off-target adverse events that may be fatal," write Mark J. Ratain, MD, FASCO, and Allen S. Lichter, MD, FASCO.

Prevalence of KRAS G12C Somatic Mutations by Cancer Type, Race, and Sex

In a study reported in a letter to the editor in The New England Journal of Medicine, Nassar et al identified the prevalence of the formerly “undruggable” KRAS G12C mutation across tumor types, race, and sex.

Reduced Frequency of Vincristine/Dexamethasone Pulses in Maintenance Therapy for Pediatric Patients With Average-Risk B-Cell ALL

As reported in the Journal of Clinical Oncology by Angiolillo et al, findings from the phase III Children’s Oncology Group AALL0932 trial indicated that “outstanding outcomes” can be achieved with maintenance therapy with a reduced frequency of vincristine/dexamethasone pulses in pediatric patients with average-risk B-cell acute lymphoblastic leukemia (ALL).