Octaplas Labeling Updated With Data Supporting Use in Critically Ill Pediatric Patients
The FDA has approved a revised product label for Octaplas (Octapharma), Pooled Plasma (Human), Solvent/Detergent Treated Solution for Intravenous Infusion.
Hematologic Disorders
Oral Plasma Kallikrein Inhibitor Prevents HAE Attacks in Phase 3 Trial
Results from a phase 3 trial evaluating BCX7353 (BioCryst), an investigational therapy for hereditary angioedema (HAE), showed that the oral plasma kallikrein inhibitor significantly reduced the rate of HAE attacks, the primary endpoint of the study.
Chemotherapy-Free Combo Therapy Approved for Previously Untreated CLL
The FDA has approved Venclexta in combination with Gazyva for the treatment of patients with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.
FDA Panel Backs Pexidartinib for Rare Tumor, Votes Against Quizartinib for FLT3-ITD AML
The Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee recently voted on 2 investigational therapies being developed by Daiichi Sankyo: pexidartinib for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT), and quizartinib for the treatment of adults with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML).
Promacta Oral Suspension Recalled Due to Possible Peanut Contamination
Three lots of Promacta (eltrombopag; Novartis) for oral suspension 12.5mg are being recalled due to possible peanut flour contamination at a third-party manufacturer.
Coagulopathy Linked to Antidiarrheal Med Ingestion in Patient With Underlying Liver Disease
The study authors noted that the patient’s elevated PT suggested vitamin K-dependent coagulation factor inhibition.
Tibsovo Approved to Treat Newly Diagnosed AML With IDH1 Mutation
The FDA has expanded the indication for Tibsovo to include treatment of newly diagnosed acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test in adult patients who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy.
Investigational Treatment for Hypereosinophilic Syndrome Granted Orphan Drug Status
The Food and Drug Administration (FDA) has granted Orphan Drug designation to dexpramipexole (Knopp Biosciences), an investigational treatment for hypereosinophilic syndrome (HES). HES is characterized by peripheral eosinophilia with evidence of organ involvement. Treatment depends on the severity of the condition and underlying cause; while steroid therapy is effective in most patients, high doses are…
Turmeric Supplementation Linked to Patient’s Iron Deficiency Anemia
The physician, who was experiencing an osteoarthritis flare following steroid therapy, began self-treating with turmeric extract capsules.
DRESS Associated With Agranulocytosis in a Patient Treated With Oxacillin
A recent report published in the American Journal of Case Reports describes a rare case of drug reaction with eosinophilia and systemic symptoms (DRESS)-induced agranulocytosis in a patient treated with the beta-lactam antibiotic oxacillin.
