Originally published by our sister publication Clinical Oncology News
By Clinical Oncology News Staff
The FDA approved selumetinib (Koselugo, AstraZeneca) granules and capsules for pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PNs).
The FDA previously approved selumetinib capsules for pediatric patients 2 years of age and older with NF1 who have symptomatic, inoperable PNs.
The approval was based on adequate bridging between the oral granule and approved capsule formulations in a relative bioavailability study in healthy adults (Study 89) and exposure matching between the pediatric patient populations in the SPRINT phase 2 Stratum I study (capsule formulation, ≥2 years of age) and SPRINKLE study (oral granule formulation, ≥1 year of age). Similar exposure between the formulations supports extrapolation of efficacy from pediatric patients from at least 1 year of age to at least 2 years of age.
The selumetinib prescribing information includes warnings and precautions for cardiomyopathy, ocular toxicity, gastrointestinal toxicity, skin toxicity, increased creatine phosphokinase, increased levels of vitamin E and increased bleeding risk (selumetinib capsules), and embryo-fetal toxicity. The incidences of warnings and precautions were updated to include data from a larger number of pediatric patients; no new safety signals were identified.
Full prescribing information for selumetinib will be posted on Drugs@FDA.
Based on a press release from the FDA.
