This week we cover the discontinuation of a trial investigating a potential COVID-19 treatment; A safety alert for toxic hand sanitizers; Vaccine guidance in the time of the pandemic; And new treatments in HIV and myelodysplastic syndromes.
The administration of cedazuridine with decitabine prevents the degradation of decitabine by CDA in the gastrointestinal tract and liver increasing its systemic exposure.
Helsinn and MEI Pharma have discontinued a phase 3 study evaluating pracinostat, in combination with azacitidine, for frontline treatment of older patients with acute myeloid leukemia.
The FDA has granted accelerated approval of Xpovio® (selinexor; Karyopharm) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy.
Tazverik, a methyltransferase inhibitor, is already indicated for the treatment of patients aged ≥16 years with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
The FDA has expanded the approval of Mylotarg (gemtuzumab ozogamicin; Pfizer) to include treatment of patients aged 1 month and older with newly-diagnosed CD33-positive acute myeloid leukemia.
Event-free survival significantly longer for children, teens with high-grade, high-risk disease.
Pediatric patients with AML may benefit from dexrazoxane as a cardioprotectant during first-line anthracycline therapy.
Darzalex Faspro is a new subcutaneous formulation that contains daratumumab, a CD38-directed cytolytic antibody, with hyaluronidase, an endoglycosidase.
The FDA has approved the supplemental Biologics License Application (sBLA) for Keytruda® (Merck) to include an additional recommended dosage of 400mg every 6 weeks across all adult indications.
