EU approves Afinitor for certain breast cancers

Swiss drug maker Novartis AG says it has received European approval to market Afinitor for treatment of women with the most common form of advanced breast cancer.

Afinitor is already approved to treat various tumors of the pancreas, kidney and brain.

The U.S. Food and Drug Administration approved the pill-based drug earlier this month for use in combination with Aromasin for postmenopausal women with recurring hormone receptor positive breast cancer lacking the protein HER2.

Novartis said Monday that the European Commission's approval was based on a trial of more than 700 patients showing those treated with the two drugs lived significantly longer before their disease progressed.

The company said recently its annual sales of Afinitor could rise above the $1 billion mark with the new approvals.

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Afinitor Approved for Advanced Breast Cancer

HealthDay – Fri, Jul 20, 2012 FRIDAY, July 20 (HealthDay News) -- 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 and Drug Administration said Friday.

The newly approved combination is sanctioned for women whose cancer has progressed or returned despite previous use of the drugs letrozole (Femara) or anastrozole (Arimidex), the agency said in a news release.

Breast cancer, the second-leading cause of cancer death among women, is expected to be newly diagnosed in an estimated 226,870 women this year and cause about 39,510 deaths, the FDA said.

Afinitor -- already sanctioned for uses including treating certain forms of advanced renal cell carcinoma -- was clinically evaluated for the new use among 724 people with advanced breast cancer. People who took the combination drug had a 4.6-month improvement in the average time to disease progression or death, compared to those who took a placebo.

The most common side effects among those taking Afinitor were mouth ulcers, infection, rash, fatigue, diarrhea and loss of appetite.

Afinitor is marketed by Novartis, based in East Hanover, N.J.

More information

The National Cancer Institute has more about breast cancer.

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FDA approves Novartis drug Afinitor for breast cancer

Reuters – 6 mins ago (Reuters) - The U.S. Food and Drug Administration said on Friday it has approved Novartis AG's drug Afinitor to treat women with a certain type of breast cancer.

The drug is the first in a class known as mTOR inhibitors to be approved for post-menopausal women with advanced hormone-receptor positive, HER2-negative breast cancer.

Afinitor, also known as everolimus, is designed to be given in combination with another drug, Aromasin, to treat women whose cancer has recurred or progressed after treatment with two other therapies.

A late-stage trial showed that patients who received Afinitor plus Aromasin had a 4.6 month improvement in the median time to disease progression or death over those receiving Aromasin plus a placebo, the FDA said.

Afinitor is already approved to treat patients with certain other types of cancer.

(Reporting By Toni Clarke; editing by Carol Bishopric)

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Afinitor Approval Expanded to Include Benign Kidney Tumors

HealthDay – 16 hrs ago FRIDAY, April 27 (HealthDay News) -- Afinitor (everolimus) is the first drug to be approved by the U.S. Food and Drug Administration to treat benign kidney tumors among people with a rare genetic condition called tuberous sclerosis complex (TSC), the agency said in a news release.

TSC causes non-cancerous tumors of the brain, kidney and other organs, the FDA said. The disease affects up to 40,000 people in the United States, and as many as 80 percent develop kidney problems.

Afinitor helps suppress these tumors by blocking a protein that's essential for their development and growth, the FDA said.

The drug's safety and effectiveness were clinically evaluated among 118 people with TSC. The most common side effects were inflamed or sore mouth, nausea and vomiting, acne, eczema, cough, headache, diarrhea, abdominal pain, joint pain and swelling of the legs or arms. Some 15 percent of females who took Afinitor missed at least one menstrual period.

Afinitor was first approved by the FDA in 2009 to treat kidney tumors that weren't treated successfully with other drugs.

Afinitor is produced by Novartis, based in East Hanover, N.J.

More information

To learn more about this drug, visit the U.S. National Cancer Institute.

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