Summary
- FDA approved axatilimab-csfr (Niktimvo) for treating chronic graft-versus-host disease in patients who have not responded to two previous treatments.
- The drug was tested in a trial with promising results, showing a 75% overall response rate in patients who received the recommended dosage.
- Common side effects of the drug include liver enzyme abnormalities, infections, and musculoskeletal pain.
- The recommended dose is based on the patient’s weight and is given as an intravenous infusion every 2 weeks.
- Healthcare professionals are encouraged to report any adverse events related to the drug to the FDA’s MedWatch Reporting System.
In recent news, the Food and Drug Administration has approved a new treatment, axatilimab-csfr, developed by Incyte Corporation, for chronic graft-versus-host disease (cGVHD). This approval comes after previous lines of systemic therapy have failed in both adult and pediatric patients weighing at least 40 kg. The efficacy of axatilimab-csfr was assessed in a clinical trial, where a significant overall response rate was observed in patients treated with the recommended dosage.
The most common adverse reactions to axatilimab-csfr include laboratory abnormalities and various infections. The recommended dose for patients weighing at least 40 kg is 0.3 mg/kg, up to a maximum of 35 mg, administered via intravenous infusion every 2 weeks. This medication was granted Priority Review and designated as an Orphan Drug and Fast Track treatment for cGVHD. Healthcare professionals are encouraged to report any suspected adverse events related to the use of this medication to the FDA’s MedWatch Reporting System. For more information, individuals can contact the Oncology Center of Excellence for assistance with investigational oncology products.
FDA_approves, Rheumatology, Transplantation