Afinitor disperz approved for rare pediatric cancer

(HealthDay)—The U.S. Food and Drug Administration has approved Afinitor Disperz (everolimus tablets for oral suspension), the first form of the anti-cancer drug Afinitor to be created especially for children.

The drug was approved for children aged 1 and older who have tuberous sclerosis complex (TSC) and an accompanying rare brain tumor, subependymal giant cell astrocytoma (SEGA), that cannot be treated with surgery.

TSC is a that often spurs tumors in the brain and other key organs, the FDA said in a news release.

Afinitor Disperz 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 agency said.

The most common side effects observed during clinical testing were mouth ulcers and respiratory infections.

Afinitor has received a number of prior approvals for adults. Both versions of the drug are produced by Novartis, based in East Hanover, N.J.

More information: The FDA has more about this approval.

add to favorites email to friend print save as pdf

Related Stories

Afinitor approved for advanced breast cancer

Jul 23, 2012

(HealthDay) -- Afinitor (everolimus) has been approved in combination with the drug exemestane to treat postmenopausal women with advanced hormone-receptor positive, HER2-negative breast cancer, the U.S. Food ...

FDA approves Novartis brain tumour drug

Oct 30, 2010

Swiss pharmaceutical company Novartis said Saturday that the US drug Food and Drug Administration had approved a drug for treating certain benign brain tumours which previously required surgery.

Recommended for you

FDA proposes accelerated medical device approval plan

3 hours ago

(HealthDay)—The U.S. Food and Drug Administration has proposed a new program that would provide expedited access to high-risk medical devices intended for patients with serious conditions whose medical ...

Targeting drugs to reduce side effects

9 hours ago

(Medical Xpress)—Consider ice cream – the base of which is frozen cream. Ingredients are then added to make different flavours. All these flavours are distinctly different but are created from the same foundation.

User comments