U.S. regulators approved Bristol-Myers Squibb Co. ’s advanced lung cancer drug Opdivo, the latest of a string of events that has focused efforts on using the immune system to battle the disease.
The action by the U.S. Food and Drug Administration came three months ahead of the agency’s deadline for reviewing the drug and just two months after a clinical trial of Opdivo was stopped early because of a significant improvement in survival. Lung cancer is the leading cause of cancer death in the U.S.
“This approval will provide patients and health care providers knowledge of the survival advantage associated with Opdivo and will help guide patient care and future lung-cancer trials,” Richard Pazdur, head of hematology and oncology products at the FDA, said.
“This is an important day for cancer patients and an important day for Bristol-Myers,” said Giovanni Caforio, the company’s chief operating officer and chief-executive officer-designate. Studies showed Opdivo has “the ability to nearly double the survival rate” for patients, “which really says it can become the standard of care for this disease,” Dr. Caforio said.
The approval amounts to an expanded indication for Opdivo, which was first approved for the market in December for patients with advanced melanoma, a skin cancer. The company plans to price the drug at about $12,500 a month, or $150,000 for patients who stay on it for a year. That is the same price as Bristol-Myers charges for the melanoma treatment.
Hope the patients have great insurance…
A cocktail of three breast cancer drugs buys patients an extra 16 months of life — a good news story so unusual, doctors have rushed to make it standard therapy, researchers said Wednesday.
The combination includes two so-called magic bullet drugs plus standard chemotherapy. It helps patients with advanced HER-2 positive breast cancer — a hard-to-treat type that’s more often than not a death sentence.
“I can’t think of something that improves survival by this much. Often, we debate over changing practice for something that extends survival by a few months, so 15.7 months that is so impressive. And really that’s exactly what I see in the clinic,” says Dr. Jennifer Keating Litton of the University of Texas MD Anderson Cancer Center. She was not involved in the trial.
The cocktail includes two drugs made to go together by California-based Genentech. They are monoclonal antibodies — lab-engineered antibodies that home in on tumor cells. One is Herceptin, originally made to fight HER-2 breast tumors, which account for about 20 percent of breast cancer cases. The second is called pertuzumab, brand name Perjeta, and it was designed to complement Herceptin.
The third drug in the combination is the standard chemotherapy drug docetaxel.
A study of about 800 patients with advanced breast cancer, meaning the disease had spread, showed that the drug combination slowed the tumors and kept the women alive longer — on average 16 months longer — than Herceptin and docetaxel alone. The women lived on average for 56 months — nearly five years — compared to the usual lifespan of two to three years.
The idea is to create a cheap screening test that people might get annually at a doctor’s office to spot a tumor at its earliest stage, when it’s more easily treated. “It took 13 years to develop the prenatal tests, but the path was untrodden,” says Lo, who is based at the Chinese University of Hong Kong. “Cancer will take a shorter time.”
The prenatal tests work by searching for fetal DNA present in a pregnant woman’s blood. Decoding that DNA can determine whether the baby has too many or too few chromosomes, problems that cause birth defects (see “Too Much Information”).
Both Lo and scientists at Johns Hopkins (see “Spotting Cancer in a Vial of Blood”) recently used a technique nearly identical to the one used in the prenatal tests to demonstrate that they could scan a person’s blood for evidence of genes that are duplicated, missing, or rearranged, something that is a hallmark of cancer cells.
But the testing strategy is very expensive. Tumor DNA is often present in tiny quantities if the cancer is at an early stage. It may account for just 0.01 percent of the DNA fragments in a blood sample. That means scientists end up decoding 9,999 bits of normal DNA for every stretch of cancer DNA they encounter. The result: building up a rough snapshot of the tumor’s genome using sequencing machines can cost $10,000 or more.
Lo says he’s now developing a different way to measure DNA that could cut the cost of the cancer test by about 90 percent.
New evidence suggests spending more time in the sun could make things brighter for men with prostate cancer. Researchers have found that vitamin D can help block a protein that causes prostate cancer tumors to grow.
According to the American Cancer Society, prostate cancer is the most common type of cancer (other than skin cancer) among males in the United States. About 1 in 7 men will be diagnosed with prostate cancer during his lifetime. Prostate cancer occurs more often in African-American men, who are also more likely to be diagnosed at an advanced stage, and more than twice as likely to die from the disease. Having a family history of prostate cancer – father or brother – more than doubles a man’s risk of developing the disease.
A University of Colorado Cancer Center study recently published in the journal Prostate presents new evidence that vitamin D may help reduce cancer-causing inflammation. Scientists found that the gene GDF-15 – known to be up-regulated by vitamin D – can help block a protein which stimulates tumor growth.
“When you take vitamin D and put it on prostate cancer cells, it inhibits their growth. But it hasn’t been proven as an anti-cancer agent,” said James Lambert, lead investigator at the University of Colorado Cancer Center. “We wanted to understand what genes vitamin D is turning on or off in prostate cancer to offer new targets.”
Scientists from Harvard Medical School have discovered a way of turning stem cells into killing machines to fight brain cancer.
In experiments on mice, the stem cells were genetically engineered to produce and secrete toxins which kill brain tumours, without killing normal cells or themselves.
Researchers said the next stage was to test the procedure in humans.
A stem cell expert said this was “the future” of cancer treatment.
The study, published in the journal Stem Cells, was the work of scientists from Massachusetts General Hospital and the Harvard Stem Cell Institute.
For many years, they had been researching a stem-cell-based therapy for cancer, which would kill only tumour cells and no others.
They used genetic engineering to make stem cells that spewed out cancer-killing toxins, but, crucially, were also able to resist the effects of the poison they were producing.
They also posed no risk to normal, healthy cells.
In animal tests, the stem cells were surrounded in gel and placed at the site of the brain tumour after it had been removed.
Their cancer cells then died as they had no defence against the toxins.
An experimental therapy has brought prolonged remissions to a high proportion of patients who were facing death from advanced leukemia after standard treatments had failed, researchers are reporting.
The therapy involves genetically programming cells from the patient’s own immune system to fight the disease.
The research included 30 patients: five adults ages 26 to 60, and 25 children and young adults ages 5 to 22. All were severely ill, with acute lymphoblastic leukemia, and had relapsed several times or had never responded to typical therapies. In more than half, the disease had come back even after a stem-cell transplant, which usually gives patients the best hope of surviving. Their life expectancy was a few months, or in some cases just weeks.
Six months after being treated, 23 of the 30 patients were still alive, and 19 of them have remained in complete remission.
The study, by researchers at the Children’s Hospital of Philadelphia and the Hospital of the University of Pennsylvania, is being published in The New England Journal of Medicine.
Estrogen may play a larger role than previously thought in the development of breast cancer.
Scientists from the University of Illinois at Urbana-Champaign discovered that estrogen readies cells to divide, grow and, in some cases, resist breast cancer drugs.
Estrogen has already been known to promote the growth and migration of breast cancer cells.
The researchers’ work, published in the journal Oncogene, could help in the development of new breast cancer treatments and help determine which patients need the most intensive treatment.
Biochemistry professor David Shapiro and his colleagues discovered that estrogen pre-activates a cellular process called the unfolded-protein response (UPR). In healthy cells, the UPR helps cells respond to stress. But in cancerous cells, activating the pathway spurs their division and subsequent expansion, and helps the cancer cells resist anticancer drugs.
A bacterium that is naturally toxic to cattle, sheep, and humans can be tweaked to fight difficult-to-treat cancer tumors.
The modified version of Clostridium novyi bacterium produced strong and precisely targeted results in cancers in rats, dogs, and now a human subject, scientists report.
Before injecting spores into tumors in test subjects, researchers removed one of the bacterium’s toxin-producing genes to make it safer for therapeutic use, though it still caused side effects.
“One advantage of using bacteria to treat cancer is that you can modify these bacteria relatively easily, to equip them with other therapeutic agents, or make them less toxic as we have done here,” says Shibin Zhou, associate professor of oncology at Johns Hopkins Kimmel Cancer Center.
In its natural form, C. novyi is found in the soil and can contaminate open wounds and cause tissue-damaging and potentially fatal infection in grazing animals and humans.
The microbe thrives only in oxygen-poor environments. That makes it suitable for destroying oxygen-starved cells in tumors that are difficult to treat with chemotherapy and radiation; at the same time, it spares nearby healthy, oxygen-rich tissue.
Taking a small daily dose of aspirin can significantly reduce the risk of developing – or dying from – bowel, stomach and oesophageal cancer, according to a large review of scientific studies.
Researchers who analyzed all available evidence from studies and clinical trials assessing benefits and harm found that taking aspirin for 10 years could cut bowel cancer cases by around 35 percent and deaths from the disease by 40 percent.
Filed under Cancer, Health
A 19-year-old Chicago teen may one day hold the key to curing colon cancer.
If his previous successes are any indication, Keven Stonewall is well on his way to becoming the kind of scientist who leaves a lasting impact in the realm of cancer research.
In his senior year of high school, this young man from the city’s South Side was already working on a potential colon cancer vaccine at a Rush University lab, DNAInfo reports.
“My friends, family members have died from cancer,” Stonewall said in a VNM video. “A lot of people are impacted by cancer. So I felt it was my role to step up and do something about it.”
At first, his friends mocked his dedication to science. When they were out on vacation, he was holed up in his lab.
“I was one of the few kids who were engaged,” Stonewall said. “At first they were making fun of me, like ‘Come on man, why you want to be in the lab all day?’”
But after realizing that his lab time was producing real results, his buddies turned around. In fact, they confessed they were inspired by him.