All Oncology News

Frederick Vogt, PhD

A rolling biologics license application has been submitted to the FDA seeking the approval of lifileucel in patients with advanced melanoma who progressed on or after previous anti–PD-1/PD-L1 therapy, and if BRAF mutation positive, also previous BRAF or BRAF/MEK inhibitor therapy.

Luspatercept, a first-in-class erythroidmaturation agent, induced high clinical activity in patients with transfusion-dependent, lower-risk myelodysplastic syndromes and ring sideroblasts who were relapsed/refractory to erythropoietin, according to findings from the phase 2 PACE-MDS study.

Ken Takeshita, MD

The European Medicines Agency has validated the marketing authorization application for quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as continuation monotherapy following consolidation, for the treatment of adult patients with newly diagnosed FLT3-ITD–mutated acute myeloid leukemia.