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A new pill called Ibrutinib, has been created to treat Chronic Lymphocytic Leukemia
Ohio State University Comprehensive Cancer
The pill, developed by The Ohio State University Comprehensive Cancer Center James Cancer Hospital and Solove Research Institute, works by targeting a particular enzyme within the cancer cells that feeds their growth.
Chronic lymphocytic leukemia, or CLL, is a cancer of the immune systems B cells, which produce antibodies, the frontline soldiers against bacterial and viral invaders. But when B cells become cancerous, they accumulate in the patients organs, including the lymph nodes, pea-shaped organs under the arms and in the groin that help the body recognize and fight infections. With CLL, the nodes swell many times their normal size.
Richard Furman, a cancer researcher at Weill Cornell Medical College in New York, says the drug idelalisib, taken twice a day, causes the cancer to melt away. When I say melt away, you can literally see the lymph nodes shrink over the course of a couple of days. It works that quickly, which is really wonderful," said Furman. The standard treatment for CLL is Rituxan, an infusion drug that destroys diseased B cells, but only for a time before the patient relapses. With repeated rounds of chemotherapy, Furman says the leukemia eventually becomes resistant to Rituxan and patients no longer respond. The cancer is fatal.
Investigators led by Furman compared a combination of idelalisib and Rituxan, to Rituxan and placebo in a group of 220 CLL patients from around the world (19 medical centers in the U.S. and five other countries). Six months into the study, 13 percent of those receiving only Rituxan responded to the therapy compared to 81 percent of the Idelalisib combination group. And 92 percent of participants in that group were still alive a year after the study began, compared to 80 percent in the Rituxan-only group.
The contrast was so significant that the study was halted early so all the patients could receive Idelalisib. And with an agent like idelalisib, which is extraordinarily well-tolerated and extraordinarily effective, my hope is that we can make CLL a chronic disease, sort of akin to high blood pressure where patients are able to take a pill a day and keep it in check," said Furman. The company that makes idelalisib has asked U.S. regulators to approve the drug within six months so it can be made available to people with chronic lymphocytic leukemia. An article on idelalisib is published in The New England Journal of Medicine.
Common Form of Leukemia Could be Treatable With New Pill
Leukemia patients in a clinical trial for the drug ONO/GS-4059, which inhibits a protein important to the growth of cancer cells, experienced what researchers are calling a dramatic effect in response to the experimental treatment. Researchers at the University of Leicester report the patients' cancer responded to the drug in nearly two-thirds of evaluable patients in the trial, with 75 percent of adverse health events associated with the treatment being minor. "These patients were confronted with a cruel reality: they had failed multiple chemotherapy lines and there were no other treatment options available for them," said Dr. Harriet Walter, a researcher at the University of Leicester, in a press release. "This drug has changed their lives; from desperate and tired they are now leading a normal and really active life."
Researchers said called the results of the drug trial even more significant because of the quick effect the treatment had on participants cancer.
The researchers started with 90 patients in January 2012 at medical centers in England and France, all of whom had one of three types of leukemia: chronic lymphocytic leukemia, or CLL; Mantle Cell Lymphoma, or MCL; and diffuse large B-cell lymphoma, or DLBCL. CLL patients showed the best response, with 96 percent responding to the drug during a median treatment period of 80 weeks. The researchers said CLL also responded quickly to ONO/GS-4059, which 21 patients continue to receive. Of patients with MCL, 92 percent responded during a median treatment period of 40 weeks and 8 patients are still being treated with the drug. Just 35 percent of patients with DLBCL responded to the drug during a median treatment period of 12 weeks, which was cut short for many patients because their cancer continued to develop. The researchers regard this response, however, as significant because of the difficulty treating DLBCL, writing in the study that the drug had "significant activity" without major drug-related toxicity.
Most also patients did not experience serious side effects during treatment with ONO/GS-4059, as researchers reported 75 percent of all health events were minor and most others were recovered from spontaneously during treatment. Researchers said further studies will be conducted that combine the drug with others to improve the overall response of disease during treatment, in addition to continuing research into how the drug works and ways to avoid potential tumor resistance to it. The study is published in the journal Blood.
Blood cancer drug has "life-changing" results in study
The Food and Drug Administration has approved a new two-drug combination for metastatic melanoma after it was shown to be more effective at slowing the growth of tumors and preventing the growth of secondary tumors in some patients. The combination was so effective with patients in a clinical trial the FDA granted it "priority review" status to speed its approval for use with patients. Vemurafenib, sold as Zelboraf, is used to treat patients with melanoma that has spread to other parts of the body and whose tumors express a gene mutation called BRAF V600E. The mutation causes melanoma to grow continuously as a cancer, an effect not completely stopped by vemurafenib according to research.
Researchers at the University of California Los Angeles combined vemurafenib with cobimetinib, sold as Cotellic, that blocks an enzyme called MEK in another signalling pathway of cancer cells, restricting the ability of tumors to grow. "[The] approval is a very significant advance in the treatment of metastatic melanoma," Dr. Antoni Ribas, a researcher at UCLA, said in a press release. "For patients with a BRAF mutated melanoma, the combination has higher activity to shrink their tumors, and with less side effects than the drugs on their own." Researchers tested the two-drug combination in a randomized study with 495 patients who had previously untreated, BRAF V600 mutation-positive melanoma. In all cases, the cancer was either advanced or could not be removed with surgery.
The two-drug combination was shown to be so effective at shrinking melanoma tumors the FDA granted it "priority" status to speed its approval for use with patients.
All the patients received vemurafenib, and then were randomly given either cobimetinib or a placebo. The researchers reported that, on average, patients taking both drugs did not see their cancer worsen for 12.3 months after treatment, as opposed to just 7.2 months for patients only given vemurafenib. Among patients given the combination, 70 percent saw complete or partial shrinkage of tumors, which only 50 percent of those taking vemurafenib and the placebo saw. Additionally, 65 percent of patients on the combination were still alive 17 months after starting treatment, while those only receiving vemurafenib had a 50 percent mortality rate.
A small subset of melanoma patients experience the growth of secondary tumors during treatment with vemurafenib -- previous studies have shown it to be about 25 percent -- however this decreased among patients who took both drugs in the clinical trial. "As we continue to advance our knowledge of tumor biology, we have learned that cancer cells have a remarkable ability to adapt and become resistant to targeted therapies," said Dr. Richard Pazdur, director of the office of hematology and oncology products at the FDA, in a press release. "Combining two or more treatments addressing different cancer-causing targets may help to address this challenge."
FDA approves drug combination for melanoma treatment
In a study published in the journal The Lancet Oncology, researchers with the International Agency for Research on Cancer in Lyon, France, reported the incidence of childhood cancer was 140 per million per year from 2001-2010 among children up to age 14. The incidence was 124 per million cancers annually throughout the 1980’s, according to data from a previous IARC study. Eva Steliarova-Foucher works in the cancer surveillance section of the IARC, which is part of the WHO. She said cancers that strike adults, notably cancers of the breast, colon and prostate, are often caused by genetic mutations that accumulate over time.
In children, she said, the disease is likely due to a genetic predisposition, adding that children tend to get different cancers than adults. “The first most common cancer in children is leukemia, and this was seen in all the regions. And then it is followed by cancers of the central nervous system in mostly high-income countries, and it was lymphoma in the other world, in low-income countries.” The data were collected from 153 cancer registries in 62 countries, departments and territories covering about 10 percent of the world’s children.
A young cancer patient is seen at a pediatric oncology clinic in Miami, Florida, Dec. 8, 2014. The number of childhood cancer cases rose by 13 percent during past two decades, according to an agency of the World Health Organization.
The best records of childhood cancers were from Western countries, including the United States, which kept records on almost 100 percent of sick children. Five percent or less of the data came from Africa and Asia, according to the report. In those low resource settings, Steliarova-Foucher says many cancers may go undiagnosed because of a lack of awareness and the unavailability of diagnostic equipment.
But she stresses that collection of data is important because, “You need to know how many cases there will be in the next years so that you have enough amenities to take care of these children. You need to know how much their treatment will cost also. So, these data provide the first indicator of the burden (of cancer) in this population.”
For the first time, the IARC report also gathered cancer data on adolescents, between the ages of 15 and 19. The incidence there was 185 cancers in one million teens each year, with lymphoma and melanoma at the top of the list. By knowing the incidence of childhood cancer, Steliarova-Foucher says researchers can begin to identify some of the factors that may contribute to childhood cancer, including environmental pollutants and infections, which might be avoided.
Cancer Incidence Increases Among Children Worldwide
What Is the New Gene Therapy?
The new therapy, developed by the Swiss drug company Novartis, is known as as CTL019 (tisagenlecleucel). It’s sometimes referred to as a “living drug,” because it relies on using a patient's own immune system to fight cancer. Doctors take a type of white blood cell called T-cells from a patient’s bloodstream, genetically modify them to attack cancer cells (as shown in the image above), then infuse them back into the patient. “This opens up a whole new world for cancer research and treatment,” says Gwen Nichols, M.D., chief medical officer of the Leukemia & Lymphoma Society, a nonprofit organization that helped fund research on the therapy.
Who Might Benefit From It?
The drug is meant to help children with B-cell acute lympoblastic leukemia (ALL) who don't respond to chemotherapy, radiation, and other existing treatments. There are about 2,500 cases of ALL in the U.S. each year, and about 620 children who don't recover with that standard care. The FDA advisory panel recommended approval based mainly on a Novartis trial, which found that among 63 such patients treated with CTL019, 52 went into remission. The therapy is intended as a last resort for children who “would otherwise die in a matter of weeks,” Nichols says. That's because the therapy, while potentially lifesaving, also carries serious risks, including a life-threatening reaction called cytokine release syndrome.
When Will the Therapy Be Available?
The FDA will make a final decision on the drug by October 2017, according to Novartis spokesperson Julie Masow. The approval of the therapy is contingent upon Novartis' response to a number of issues, including chemistry, manufacturing, and safety questions. CTLO19 was designated as a "breakthrough therapy" by the FDA back in 2014, which the agency grants to drugs that treat serious or life-threatening conditions and that demonstrate the potential to be significantly more effective than existing therapies.
But because of the complexity and novelty of the CTL019, says Masow, it will initially be offered at just 30 to 35 treatment centers in the U.S. "This strategy will help ensure that each site is fully prepared with the necessary infrastructure in place to support the special ordering, cell collection, chain of identity, use, and site-level care associated with CTL019," Masow says.
How Much Will It Cost?
First Gene Therapy for Deadly Childhood Cancer...
What Families Need to Know About First Gene Therapy for Deadly Childhood Cancer
July 14, 2017 - An advisory panel to the Food and Drug Administration earlier this week unanimously recommended approving a breakthrough genetic therapy to treat a rare but deadly type of childhood cancer. Here's why the news has cancer researchers excited—and what it means for families with children diagnosed with the cancer.
What Is the New Gene Therapy?
The new therapy, developed by the Swiss drug company Novartis, is known as as CTL019 (tisagenlecleucel). It’s sometimes referred to as a “living drug,” because it relies on using a patient's own immune system to fight cancer. Doctors take a type of white blood cell called T-cells from a patient’s bloodstream, genetically modify them to attack cancer cells (as shown in the image above), then infuse them back into the patient. “This opens up a whole new world for cancer research and treatment,” says Gwen Nichols, M.D., chief medical officer of the Leukemia & Lymphoma Society, a nonprofit organization that helped fund research on the therapy.
Who Might Benefit From It?
The drug is meant to help children with B-cell acute lympoblastic leukemia (ALL) who don't respond to chemotherapy, radiation, and other existing treatments. There are about 2,500 cases of ALL in the U.S. each year, and about 620 children who don't recover with that standard care. The FDA advisory panel recommended approval based mainly on a Novartis trial, which found that among 63 such patients treated with CTL019, 52 went into remission. The therapy is intended as a last resort for children who “would otherwise die in a matter of weeks,” Nichols says. That's because the therapy, while potentially lifesaving, also carries serious risks, including a life-threatening reaction called cytokine release syndrome.
When Will the Therapy Be Available?
The FDA will make a final decision on the drug by October 2017, according to Novartis spokesperson Julie Masow. The approval of the therapy is contingent upon Novartis' response to a number of issues, including chemistry, manufacturing, and safety questions. CTLO19 was designated as a "breakthrough therapy" by the FDA back in 2014, which the agency grants to drugs that treat serious or life-threatening conditions and that demonstrate the potential to be significantly more effective than existing therapies.
But because of the complexity and novelty of the CTL019, says Masow, it will initially be offered at just 30 to 35 treatment centers in the U.S. "This strategy will help ensure that each site is fully prepared with the necessary infrastructure in place to support the special ordering, cell collection, chain of identity, use, and site-level care associated with CTL019," Masow says.
How Much Will It Cost?
