HealthDay News — The FDA has approved a pediatric dose of the cancer drug everolimus (Afinitor Disperz, Novartis), to treat rare brain tumors in children aged 1 year and older. Prior to approval of this new dosage form, everolimus was recommended for use only in patients ages 3 years old and older.
The drug is indicated for children who have tuberous sclerosis complex (TSC) and an accompanying rare but benign brain tumor, subependymal giant cell astrocytoma (SEGA), that cannot be treated with surgery.
Pediatric everolimus is available in smaller doses than its adult counterpart. It also is meant to dissolve in a small amount of water, making it easier to give to children who can’t swallow tablets, the FDA said in a statement.
The most common adverse events observed during clinical testing were mouth ulcers and respiratory infections.
Everolimus has received a number of prior approvals for adults, including as treatment for advanced renal cell carcinoma that has progressed after treatment with other cancer therapies, patients with progressive advanced neuroendocrine tumors of pancreatic origin, patients with TSC who have renal angiomyolipomas not requiring immediate surgery, and for use in combination with exemestane (Aromasin) to treat certain postmenopausal women with advanced hormone-receptor positive, HER2-negative breast cancer.