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FDA approves smaller-dose Afinitor for rare brain tumor in children

BY Alaric DeArment

SILVER SPRING, Md. — The Food and Drug Administration has approved a new formulation of a cancer drug made by Novartis for a type of brain tumor in children, the agency said.

The FDA announced the approval of Afinitor Disperz (everolimus) tablets for oral suspension to treat a rare brain tumor called subependymal giant-cell astrocytoma, or SEGA. The agency said Afinitor Disperz, a new dosage form of the drug Afinitor, is the first pediatric-specific dosage form for a pediatric tumor to receive FDA approval.

The drug, designed to dissolve in water, is recommended for patients aged 1 year and older with tuberous sclerosis complex who are diagnosed with SEGA that can’t be treated with surgery. TSC is a rare genetic disease that causes tumors to grow in the brain and other vital organs, while SEGA is a slow-growing tumor that can cause life-threatening complications by blocking the flow of blood to the brain, occurring in 6-9% of TSC patients.


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Astellas, Medivation cancer drug wins FDA approval

BY Alaric DeArment

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by Astellas Pharma U.S. and Medivation for treating prostate cancer, the agency said Friday.

The FDA announced the approval of Xtandi (enzalutamide) for castration-resistant prostate cancer that has spread or recurred despite medical or surgical therapy to minimize testosterone.

"The need for additional treatment options for advanced prostate cancer continues to be important for patients," FDA Office of Hematology and Oncology Products director Richard Pazdur said. "Xtandi is the latest treatment for this disease to demonstrate its ability to extend a person’s life."

About 241,740 men will be diagnosed with prostate cancer, and 28,170 will die from it this year, according to the National Cancer Institute, part of the National Institutes of Health.


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Bayer HealthCare brings OTC migraine relief to analgesic shelves

BY Michael Johnsen

MORRISTOWN, N.J. — Bayer HealthCare’s Consumer Care Division on Tuesday introduced Bayer Migraine Formula, an over-the-counter medication designed to relieve migraine pain and accompanying symptoms like nausea, phonophobia (sound sensitivity) and photophobia (light sensitivity) through a formulation of aspirin, acetaminophen and caffeine.

"Consumers have been extremely vocal about the lack of OTC options tough enough to target throbbing migraine pain," stated Reese Fitzpatrick, Bayer Aspirin director marketing. The new formula contains the same three active ingredients and dosages for migraine relief as Novartis’ Excedrin Migraine, which became unavailable earlier this year, Bayer noted.

Bayer Migraine Formula will be packaged in a 50-count or 200-count bottle of coated caplets.


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