FDA Approval Summary: Axatilimab for Adult and Pediatric Patients Weighing at Least 40 Kilograms with Chronic GVHD after Two Prior Lines of Systemic Therapy.

On August 14, 2024, the FDA approved axatilimab, a colony-stimulating factor-1 receptor-blocking antibody, for chronic GVHD after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kilograms (kg). Approval was based on the results of the AGAVE-201 Study (NCT04710576), which included a cohort of 79 patients with chronic GVHD treated with axatilimab 0.3 mg/kg administered intravenously every 2 weeks in an open-label, single-arm cohort.

FDA Approval Summary: Abatacept for the Prophylaxis of Acute GVHD.

In December 2021, the FDA approved abatacept (Orencia; Bristol Myers Squibb) in combination with a calcineurin inhibitor (CNI) and methotrexate (MTX) as the first drug for the prophylaxis of acute GVHD (aGVHD) in adult and pediatric (2 years of age and older) patients undergoing hematopoietic stem cell transplantation (HSCT) from a matched or one allele-mismatched unrelated donor (URD). Study IM101311 included a randomized (1:1), double-blind evaluation of abatacept (N = 73) versus placebo (N = 69) +CNI+MTX as aGVHD prophylaxis in patients ≥6 years undergoing an 8/8 HLA-matched URD HSCT. Overall survival and grade II-IV aGVHD-free survival at day 180 after transplantation for abatacept versus placebo showed HRs [95% confidence interval (CI)] of 0.

FDA Approval Summary: Teclistamab-A Bispecific CD3 T-Cell Engager for Patients with Relapsed or Refractory Multiple Myeloma.

On October 25, 2022, the FDA granted accelerated approval to teclistamab-cqyv (TECVAYLI; Janssen Biotech) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 mAb. Substantial evidence of effectiveness was obtained from the MajesTEC-1 trial, a phase I/II, single-arm, open-label, multicenter study. Patients received step-up doses of teclistamab at 0.

Pharmacokinetic Considerations for Optimizing Inhaled Spray-Dried Pyrazinoic Acid Formulations.

Tuberculosis (TB), caused by (), remains a leading cause of death with 1.6 million deaths worldwide reported in 2021. Oral pyrazinamide (PZA) is an integral part of anti-TB regimens, but its prolonged use has the potential to drive the development of PZA-resistant .

Pharmacokinetic considerations for optimizing inhaled spray-dried pyrazinoic acid formulations.

Tuberculosis (TB), caused by ( ), remains a leading cause of death with 1.6 million deaths worldwide reported in 2021. Oral pyrazinamide (PZA) is an integral part of anti-TB regimens, but its prolonged use has the potential to drive development of PZA resistant .

Rivaroxaban Precision Dosing Strategy for Real-World Atrial Fibrillation Patients.

Rivaroxaban is a direct-acting oral anticoagulant approved to prevent strokes in patients with atrial fibrillation. Dosage recommendations are approved for all adult patients to receive either 15 mg or 20 mg once daily depending upon renal function. There are a number of reasons to believe rivaroxaban dosing could be more effective and/or safer for more patients if increased dosing precision is available.

Therapeutic Drug Monitoring Can Improve Linezolid Dosing Regimens in Current Clinical Practice: A Review of Linezolid Pharmacokinetics and Pharmacodynamics.

Linezolid is an antibiotic used to treat infections caused by drug-resistant gram-positive organisms, including vancomycin-resistant Enterococcus faecium, multi-drug resistant Streptococcus pneumoniae, and methicillin-resistant Staphylococcus aureus. The adverse effects of linezolid can include thrombocytopenia and neuropathy, which are more prevalent with higher exposures and longer treatment durations. Although linezolid is traditionally administered at a standard 600 mg dose every 12 hours, the resulting exposure can vary greatly between patients and can lead to treatment failure or toxicity.