FDA Gives Nod to New Breast Cancer Drug

FRIDAY, July 20 (HealthDay News) — The U.S. Food and Drug
Administration on Friday approved the use of the drug Afinitor
(everolimus) for use by women with a particular form of advanced breast
cancer.

It’s the first time that a drug from this class of medications, called
mTOR inhibitors, has been approved for this disease, the FDA said.
Afinitor is already used to fight advanced kidney and neuroendocrine
tumors, as well as a handful of rarer cancers.

The medicine is only approved for use by postmenopausal women battling
an advanced form of estrogen-sensitive tumor known as hormone-receptor
positive, HER2-negative breast cancer. Even then, Afinitor should only be
used after such patients have already experienced a recurrence or
progression of the tumor following prior treatment with Femara (letrozole)
or Arimidex (anastrozole), the FDA said.

Adding Afinitor — which has proven effective for other cancers — to
therapy might help these patients, the agency said.

“Afinitor is another example of the value of continuing to study drugs
in additional types of cancer after their initial approval,” Dr. Richard
Pazdur, director of the Office of Hematology and Oncology Products in the
FDA’s Center for Drug Evaluation and Research, said in an agency news
release.

According to the FDA, approval was based on a clinical trial involving
724 postmenopausal women with advanced breast cancer that had spread
despite prior treatment with Femara or Arimidex. All of the women also
took the standard breast cancer drug Aromasin (exemestane) during the
trial.

The trial found that adding in Afinitor boosted average
progression-free survival (the time the women lived without any
progression of their tumor) by 4.6 months compared to women taking an
inactive placebo.

There was a downside to using Afinitor, however: According to the FDA,
side effects included rash, fatigue, diarrhea, loss of appetite and mouth
ulcers. These effects were more common in women aged 65 or older, so the
agency says older patients should be monitored more closely if they take
Afinitor.

Dr. Stephanie Bernik, chief of surgical oncology at Lenox Hill Hospital
in New York City, commented on Afinitor’s approval.

“It is exciting that there continues to be advances in treating breast
cancer that are allowing patients to survive longer, even in the face of
metastatic disease,” Bernik said. “The improved treatment for
advanced-stage breast cancer offers women hope that a treatment to
completely stabilize, or even eradicate the disease, might be achievable
within their lifetime.”

The drug is marketed by Novartis Pharmaceuticals Corp., based in East
Hanover, N.J.

More information

Find out more about breast cancer at the U.S.
National Cancer Institute
.

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