More good news for Afinitor. The Novartis cancer drug shrank benign brain tumors in a new study, adding to its arsenal of data supporting new uses. The Phase III study of patients with subependymal giant cell astrocytoma, or SEGA, found that more than a third of Afinitor users saw a 50% or greater reduction in the size of their tumors. No placebo patients in the study saw a reduction of that size.
Afinitor is already approved in SEGA associated with the genetic disorder tuberous sclerosis in the U.S. and 6 other countries, and under the brand name Votubia in Switzerland. It's recommended for approval for that use in the EU. The new trial lends weight to data from an earlier stage study, Novartis said. Of course, Afinitor also has the regulatory OK as a treatment for kidney cancer and certain types of pancreatic cancer.
This is the second positive study for Afinitor this week. Another late-stage study found that Afinitor put the brakes on tumor growth in advanced breast cancer, an indication that could add more than $1 billion to the drug's peak sales. The company said it would be filing for that approval by year's end, hoping for an FDA nod by next year.
- see the release from Novartis
- read the Reuters news
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