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 AG (NOVN)’s 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 in a telephone interview from her home in Houston. While on the drug, “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 last week. 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 AG (ROG), 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 Plc (AZN)’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.
Doctor and Patient
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whose tumors have spread after initial treatment are looking for new options after Avastin’s approval for breast cancer was revoked in November.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.
‘Not as Sick’
“It’s showing more significant benefit, but it’s also not making people as sick as some of the other therapies,” she said in a telephone interview. “It’s very promising.” Litton was an investigator in the trial that Novartis used to apply for FDA approval of Afinitor for breast cancer. She doesn’t hold Novartis stock and gets no personal compensation from the company, she said.
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 in a telephone interview. “That’s the judgment that doctors have to make over and over again.”
Marshmallow or Whipped Cream
Midgett says she had sores on her tongue at the beginning, 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.”
Midgett continues to work as a sales representative for UCB SA (UCB), selling the Belgian company’s arthritis medicine Cimzia.
Afinitor was cleared for breast cancer patients whose disease has spread after earlier treatment, and who lack a gene called HER2, the FDA said on July 20 after the Swiss stock market closed. Novartis rose 0.2 percent to 56.30 Swiss francs at 9:30 a.m. in Zurich today. European regulators recommended approving Afinitor for breast cancer last month.
Sales of Afinitor, which climbed 66 percent to $318 million in the first half, may reap $2.5 billion by 2016, according to Tim Race, an analyst with Deutsche Bank AG in London. Breast cancer alone would account for $1.5 billion, Race estimates.
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 Inc. (PFE) 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.
Blocking a Protein
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.
While the test needs to run for longer for the company to conclude that Afinitor has a survival benefit, the trend is “pointing in the right direction,” says Deutsche Bank’s Race.
Afinitor also delayed the progression of breast cancer by a median of 7.8 months compared with 3.2 months among patients receiving Aromasin alone.
Roche, which sits 2 miles down the Rhine river from Novartis’s headquarters, 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 to show the product’s impact on the most common form of breast tumors.
“We do believe the drug works,” Daniel Grotzky, a Roche spokesman, said by telephone. Roche is still able to market Avastin for breast cancer treatment in Europe.
After a year on Afinitor, Midgett’s cancer started growing again at the end of February. Now she’s on a new trial involving a combination of Bristol-Myers Squibb Co. (BMY)’s Taxol and an experimental drug from Takeda Pharmaceutical Co. (4502) Midgett, who’s lived three years since her initial diagnosis, says she’s grateful because the drug prolonged her life already.
“A textbook prognosis for someone like me is two years,” she says. “I just feel very blessed that I’ve made it this far. Every day is a gift.”
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