Afinitor Approved by FDA for SEGA

Novartis’ cancer drug Afinitor has gained the approval of the U.S. Food and Drug Administration (FDA) to treat patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis (TS), a rare genetic disorder.

Afinitor (everolimus) was approved under the FDA’s accelerated approval program. This program allows patients to have an earlier access to the drug even while confirmatory clinical trials are still being conducted.

An FDA news release tells us more about a study involving 28 patients to test the safety and effectiveness of the drug in treating SEGA:

“At six months into the study, nine patients (32 percent) had a greater than 50 percent reduction in space the tumor occupied (tumor volume) of their largest SEGA tumor lesion. The length of time from when a patient’s tumor visibly shrank and then remained stable (duration of response) for these nine patients ranged from about three months to two and one-half years with a median of 266 days. Seven of these patients retained the greater than 50 percent reduction in space the tumor occupied at time of last follow up.

Patients participating in the study did not develop any new tumors. However, no tumor resolved completely. Four of the patients on this study had previous surgery, but their tumor grew back. After receiving Afinitor, three of these patients experienced greater than 50 percent reduction in tumor volume.”

According to the release, the most common side-effects of the drug felt by the participants include upper respiratory tract infections, sinus and ear infections, mouth sores and fever.

The drug is being marketed by Easter Hanover, N.J.-based Novartis. The FDA approved its use to treat kidney cancer in March 2009.

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