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Novartis’ Afinitor gets OK of FDA

Might extend life of cancer patients

– Chemotherapy robbed Rachel Midgett of her hair, appetite and energy as she battled breast cancer that had spread to her liver. After nine months on Novartis’ Afinitor, she ran a half-marathon in Las Vegas in December.

Midgett, 40, is scheduled to have surgery next month to cut the tumor from her liver after undergoing a previous operation to remove her breasts. The procedure could leave her disease-free for the first time since she was diagnosed in 2009.

“I’m a huge fan of Afinitor. It prolonged my life,” Midgett said at home in Houston. “I felt like a normal human being again.”

The medicine, which traces its origins to a bacteria that lurks in the soil around Easter Island and its mysterious stone monoliths, won U.S. approval for breast cancer this month. That green light could give Chief Executive Officer Joe Jimenez a welcome $1.5 billion sales boost just as some of the company’s top sellers lose patent protection, including the top-selling blood pressure pill Diovan and the cancer drug Gleevec.

With Afinitor, Novartis is treading on the toes of crosstown rival Roche Holding, the biggest seller of cancer drugs, which lost permission last year to market its blockbuster Avastin for breast tumors in the U.S. after failing to prove that the drug extended patients’ lives.

Midgett got Afinitor, combined with AstraZeneca’s Arimidex, as part of a clinical trial at MD Anderson Cancer Center in Houston. Other patients, encouraged by stories like hers and positive test results, started asking for the drug even before the Food and Drug Administration cleared it, said Jennifer Litton, a breast cancer specialist at MD Anderson.

While Litton said she didn’t promote the use of the drug prior to its regulatory approval, doctors can prescribe treatments for their patients that are approved for other diseases. Prior to clearance for breast cancer, Afinitor was sold in the U.S. for tumors of the kidney and pancreas.

Women whose tumors have spread after initial treatment are looking for new options after Avastin’s approval for breast cancer was revoked in November. While Afinitor has yet to demonstrate it can prolong life, preliminary data showed a trend toward extended survival.

The Novartis product also comes without some of the “devastating side effects” of Avastin, according to Litton. Roche’s medicine was linked to high blood pressure, bleeding, hemorrhage and heart attacks.

Litton, an investigator in the trial that Novartis used to apply for FDA approval of Afinitor for breast cancer, said she doesn’t hold Novartis stock and gets no personal compensation from the company.

“It’s showing more significant benefit, but it’s also not making people as sick as some of the other therapies,” she said. “It’s very promising.”

Still, taking the drug may have drawbacks. The side effects patients report from Afinitor, also known by its chemical name everolimus, can include mouth ulcers, change in taste, and mild cases of rash, diarrhea, loss of appetite and weight loss, said Clifford Hudis, chief of the breast cancer medicine service at Memorial Sloan-Kettering Cancer Center in New York.

“Are the toxicities of everolimus mild enough that it’s worth it to be on that for a five- or six-month delay in the initiation of chemotherapy?” Hudis said. “That’s the judgment that doctors have to make over and over again.”

Midgett says she had sores on her tongue until she started taking the pill encased in a marshmallow. Other patients told her they favor whipped cream, she said.

After that, “my only side effect was joint pain,” she said. “For about 10 or 15 minutes every morning, I was wobbling around because my ankles and feet and knees hurt. My hair grew back; I didn’t have any bloodwork problems; I didn’t have fatigue.”

The condition is the biggest cancer killer among women. About 1.4 million cases are newly diagnosed every year, and almost 460,000 women die, according to the International Agency for Research on Cancer in Lyon, France.

The Swiss drugmaker developed Afinitor from a bacteria first identified in the late 1960s on Easter Island. Researchers isolated an antifungal agent from the bug in 1975 that became known as rapamycin and is sold by Pfizer as Rapamune to prevent the rejection of kidney transplants.

Afinitor is derived from rapamycin, which Novartis gets from bacteria it grows at a plant in Stein, Switzerland. The company has sold the drug since 2003 under the brand names Certican and Zortress for organ transplant patients and since 2009 as Afinitor for kidney cancer.

The drug works by blocking a protein called mTOR that some cancer cells require to grow and multiply. That can enhance and prolong the effect of cancer-killing drugs such as Pfizer’s Aromasin, which belong to a class of treatments called aromatase inhibitors.

In a clinical trial among 724 women whose cancer had progressed after hormone therapy, 25 percent of those receiving a combination of Afinitor and Aromasin died after 18 months, compared with 32 percent of patients receiving Aromasin alone, according to data presented at the American Society of Clinical Oncology’s annual meeting in Chicago in May.

Roche hasn’t given up on its own drug Avastin for breast cancer. Besides selling the medicine for colon, lung, kidney and brain cancer in the U.S., it plans to start a new study this year on breast tumors.

Roche is still able to market Avastin for breast cancer treatment in Europe.