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The drug, Tecentriq from Roche, works by using the body’s immune system against tumors, and is the first drug of its type approved for bladder cancer.
@BladderCancerCA: F.D.A. Approves an #Immunotherapy Drug for Bladder Cancer
The Food and Drug Administration on Wednesday approved a new immunotherapy drug from Roche to treat bladder cancer, a form of cancer for which there have been no significant new medicines in years.
The drug, called Tecentriq, is the fourth medicine of a new class called checkpoint inhibitors that work by unleashing the body’s immune system to attack tumors.
But it is the first of them approved for bladder cancer. And it is the first one for Roche, which is the world’s leading seller of cancer drugs but fell behind rivals in immunotherapy, the hottest area in oncology right now.
Former President Jimmy Carter recently went into remission after using one of these drugs, Merck’s Keytruda, for metastatic melanoma. The two other approved drugs in the class are Yervoy and Opdivo, both from Bristol-Myers Squibb.
Yervoy is approved to treat melanoma, Keytruda to treat melanoma and lung cancer, and Opdivo to treat melanoma, lung cancer and kidney cancer. On Tuesday, Opdivo was approved to treat Hodgkin lymphoma, a blood cancer.
How much of an impact immunotherapy will have on bladder cancer is a bit unclear since patients have not been followed for a long time. But the F.D.A. found Roche’s data compelling enough, and the need urgent enough, to approve Tecentriq about four months ahead of the agency’s Sept. 12 deadline.
Gene Zawatski, a retired Pennsylvania state police officer with bladder cancer, said the chemotherapy he got every Thursday after having his bladder removed kept the disease in check but knocked him out. “By Saturday I was bedridden,” he said. “I couldn’t get off the couch until Monday or Tuesday.”
He started taking Tecentriq, known generically as atezolizumab, two years ago as part of a clinical trial. The cancer has disappeared, and he has had no side effects other than a sore shoulder.
“I feel normal,” said Mr. Zawatski, whose brother died of bladder cancer. “Well, as normal as a 77-year-old man would feel.”
There are expected to be about 77,000 new cases of bladder cancer this year in the United States and 16,000 deaths, according to the American Cancer Society. About three-quarters of the cases are in men, making bladder cancer the fourth most common cancer in men. It is treated with surgery, chemotherapy and radiation, though those are not very effective once the cancer is in advanced stages.
Tecentriq was approved for urothelial carcinoma, which accounts for 90 percent of all bladder cancers, in cases in which the disease is locally advanced or metastatic and not controlled by platinum chemotherapy. The F.D.A. granted accelerated approval, meaning Roche will have to perform additional studies to confirm the drug works.
Tecentriq will cost about $12,500 a month. That is roughly in line with the price of the competing checkpoint drugs. The high price of drugs, including cancer drugs, has become a public concern and political issue lately.
In the study that formed the basis of the approval, Tecentriq shrank tumors significantly in 14.8 percent of the patients, and the cancer completely disappeared in 5.5 percent. There was no control group with which to compare those results.
It is not yet clear whether the drug will allow people to live longer. But the other checkpoint inhibitors do allow a certain percentage of the population to live a long time, and Roche executives say this appears to be the case with its drug as well.
Roche, based in Switzerland, is the leading supplier of cancer drugs because of its acquisition of the American biotechnology company Genentech, which developed the blockbusters Rituxan, Herceptin and Avastin.
Now it is trying to catch up in immunotherapy, which is one reason it sought its first approval for bladder cancer, a territory not yet claimed by Merck or Bristol-Myers, though they are testing their drugs for that disease as well.
Bladder cancer is a good candidate for an immune system drug because the tumors tend to have many mutations, which alert the immune system to the presence of the disease. Melanomas and lung cancers also have many mutations, which in melanomas are caused by ultraviolet radiation, and in lung cancers by smoking. For bladder cancer the mutations probably result from the bladder’s role in eliminating toxins from the body.
“Over your lifetime, it’s a place where toxins and chemicals can accumulate,” said Dr. Dan Chen, head of product development for cancer immunotherapy at Genentech.
Some early-stage bladder cancer is already treated with a cruder, decades-old form of immunotherapy — BCG, a bacterium that is used as a tuberculosis vaccine. It can be inserted into the bladder through a catheter and is thought to stimulate the immune system in a general way that helps combat the cancer.
Tumors and certain immune system cells can make a protein called PD-L1. It binds to a protein on the immune system T cells called PD-1, which then acts as a molecular brake, preventing the T cells from attacking the cancer cells.
Tecentriq, like Keytruda and Opdivo, prevents PD-L1 from binding to PD-1, in that way freeing the immune system to attack. While Keytruda and Opdivo do that by binding to PD-1, Tecentriq instead binds to PD-L1. Roche argues this will make its drug potentially safer, but so far many experts see little difference among the drugs.
Roche’s study found that the drug was most likely to be successful for the roughly one-third of patients with high levels of PD-L1 near the tumor. About 26 percent of those patients experienced significant tumor shrinkage, and 12 percent had complete remissions. Among those whose tumors had low or undetectable levels of PD-L1, 9.5 percent had tumor shrinkage and 2.4 percent complete remissions.
Still, Roche applied for and was granted approval to treat all patients with advanced bladder cancer, not just those with high PD-L1 levels. While the F.D.A. Wednesday also approved a test for PD-L1 developed by a Roche subsidiary, doctors will not be required to use it.
Common side effects include fatigue, loss of appetite and nausea, though Tecentriq can also cause severe inflammations of organs like the lungs or colon.