The U.S. Food and Drug Administration approved Afinitor without proof that it extended life.
Despite the lack of proof, the drug has come before the FDA five times in the last six years and has gained approval each time for a new use. Afinitor is now approved to treat advanced breast and kidney cancer, a rare type of pancreatic tumor and two types of nonmalignant tumors.
The drug has a grocery list of side effects which include: mouth sores, infections, fatigue, diarrhea, abdominal pain, fever, cough, headache, and decreased appetite. In clinical trials, each of these side effects occurred in at least 30% of patients.
The advanced breast cancer trial showed that 63% of those taking Afinitor had to cut the dose of the drug or temporarily stop treatment, compared with 14% who got a placebo. About 24% had to stop using it altogether, compared with 5% who got a placebo.
About 1 in 5 developed a potentially fatal lung condition known as noninfectious pneumonitis.
Afinitor first got on the market in 2009 and since then there have been nearly 9,000 reports of serious adverse reactions among Afinitor users. These serious adverse reactions include more than 2,700 deaths and more than 3,100 hospitalizations.
Each FDA approval of Afinitor for a new condition increased the pool or potential patients and potential sales for the drug.
Between 2005 and 2014, prescriptions for Afinitor rose from 12,500 to nearly 70,000 according to IMS Health.
In the U.S. sales increased from $110 million in 2010 to $803 million last year. This increase has made it one of the nation’s top selling cancer drugs.
According to Novartis, worldwide, the drug is on pace for its best year with more than $1.2 billion in sales through October.
A Journal Sentinel/MedPage Today investigation found that last year 74% of new cancer drugs approved in the past decade got on the market without proof that they increased survival. Afinitor, like a variety of other drugs, was approved based on its ability to slow the progression of tumors, which is considered a “surrogate measure” of effectiveness.
The use of “surrogate measures” of effectiveness allow for quicker, smaller, and cheaper clinical trials. These types of trials are favored by drug companies and commonly accepted by the FDA.
Independent experts fault the FDA for not setting the bar higher and for not requiring drug companies to develop more drugs with proven clinical benefits.
However, Afinitor stands out, even among the other cancer drugs, for its repeated approvals despite what independent doctors say are serious concerns.
In fact, Novartis, is continuing to push for new uses for the drug. The company is hoping for FDA approvals of Afinitor for three new conditions. The FDA is expected to rule in the coming months.