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Chronic Myelogenous Leukemia (CML) Blog

Related terms: Cancer, Chronic Myelogenous Leukemia, Chronic Granulocytic Leukemia, Leukemia, Chronic Granulocytic, CML

FDA Approves U.S. Product Labeling Update for Sprycel (dasatinib) to Include Three-Year First-Line and Five-Year Second-Line Efficacy and Safety Data in Chronic Myeloid Leukemia in Chronic Phase

Posted 23 Jun 2013 by Drugs.com

Data added to Sprycel U.S. labeling are among the longest follow-up data of current CML treatment options PRINCETON, N.J., June 20, 2013--(BUSINESS WIRE)--Bristol-Myers Squibb Company and Otsuka America Pharmaceutical, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved an update to the Sprycel (dasatinib) product labeling. The labeling now includes three-year efficacy and safety data in patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP) and five-year data in CP Ph+ CML patients who are resistant or intolerant to Gleevec1 (imatinib mesylate). Sprycel is a kinase inhibitor indicated for the treatment of adults with newly diagnosed CP Ph+ CML. The effectiveness of Sprycel is based on cytogenetic response and major molecular response rates. The trial is ongoing and further data will be ... Read more

Related support groups: Chronic Myelogenous Leukemia (CML), Sprycel, Dasatinib

Gene Discovery May Offer Breakthrough for Rare Leukemia

Posted 10 May 2013 by Drugs.com

THURSDAY, May 9 – In the war against cancer, it looks like matchmaking – between genes and drugs – could be an important tool, according to new research into the genetic underpinnings of two rare forms of leukemia. By matching a patient's genetic mutation responsible for a rare, rapidly progressing form of leukemia with a drug that specifically targets the problem the mutation creates, researchers report that one patient is experiencing fast, marked improvement. The new findings shed light on how many forms of cancer may be tackled in the near future. Scientists are discovering how to differentiate between mutations that are driving the proliferation of cancer cells and those that are merely passengers in the process. "If your car breaks down, you have to open up the hood to see what part has broken," said study author Jeffrey Tyner, an assistant professor at the Knight Cancer ... Read more

Related support groups: Leukemia, Chronic Myelogenous Leukemia (CML)

Soaring Prices Keep Leukemia Drugs From Patients, Experts Say

Posted 25 Apr 2013 by Drugs.com

THURSDAY, April 25 – Pricey cancer medications prevent many Americans with chronic myeloid leukemia (CML) from receiving lifesaving treatment, an international team of experts claims. These drugs can cost more than $100,000 a year for patients with CML, once considered a death sentence but now highly treatable with ongoing treatment, according to a commentary penned by 120 specialists in more than 15 countries and published online April 25 in the journal Blood. "Patients with CML have a much better outlook today than ever before, thanks to advances that have greatly improved survival rates. But these patients now face dire financial struggles as they try to maintain their treatment regimen with the drastically inflating cost of care," corresponding author Dr. Hagop Kantarjian, chairman of the leukemia department at the University of Texas MD Anderson Cancer Center in Houston, said in a ... Read more

Related support groups: Chronic Myelogenous Leukemia (CML), Leukemia, Gleevec, Sprycel, Dasatinib, Imatinib, Bosutinib, Bosulif, Omacetaxine, Synribo

FDA Approves Iclusig to Treat Two Rare Types of Leukemia

Posted 17 Dec 2012 by Drugs.com

December 14, 2012 - The U.S. Food and Drug Administration today approved Iclusig (ponatinib) to treat adults with chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), two rare blood and bone marrow diseases. Iclusig is being approved more than three months ahead of the product’s prescription user fee goal date of March 27, 2013, the date the agency was scheduled to complete review of the drug application. The FDA reviewed the Iclusig drug application under the agency’s priority review program, which provides for an expedited six-month review for drugs that may provide safe and effective therapy when no satisfactory alternative therapy exists, or offer significant improvement compared to marketed products. Iclusig blocks certain proteins that promote the development of cancerous cells. The drug is taken once a day to treat patients ... Read more

Related support groups: Leukemia, Chronic Myelogenous Leukemia (CML), Acute Lymphoblastic Leukemia

FDA Approves Synribo for Chronic Myelogenous Leukemia

Posted 28 Oct 2012 by Drugs.com

October 26, 2012 - The U.S. Food and Drug Administration today approved Synribo (omacetaxine mepesuccinate) to treat adults with chronic myelogenous leukemia (CML), a blood and bone marrow disease. An estimated 5,430 people will be diagnosed with CML in 2012, according to the National Institutes of Health. Synribo is intended to be used in patients whose cancer progressed after treatment with at least two drugs from a class called tyrosine kinase inhibitors (TKIs), also used to treat CML. Synribo blocks certain proteins that promote the development of cancerous cells. It is injected just under the skin (subcutaneously) twice daily for 14 consecutive days over a 28-day cycle until white blood cell counts normalize (hematologic response). Synribo is then administered twice daily for seven consecutive days over a 28-day cycle as long as patients continue to clinically benefit from ... Read more

Related support groups: Chronic Myelogenous Leukemia (CML)

Bosulif Approved for Rare Leukemia

Posted 5 Sep 2012 by Drugs.com

WEDNESDAY, Sept. 5 – Bosulif (bosutinib) has been approved by the U.S. Food and Drug Administration to treat chronic myelogenous leukemia (CML), a cancer of the blood and bone marrow that primarily affects older people, the agency said in a news release. Some 5,430 people are expected to be diagnosed this year with the disease, which primarily is caused by a genetic mutation called the Philadelphia chromosome, the FDA said. This abnormality causes a person's bone marrow to produce an enzyme that triggers development of abnormal white blood cells known as granulocytes. The new drug works to block the effects of this enzyme. Bosulif was evaluated in a clinical trial that included 546 adults with CML. The drug's most common side effects included diarrhea, nausea, low blood platelets, abdominal pain, rash, anemia, fever and fatigue. The drug is marketed by Pfizer, based in New York City. ... Read more

Related support groups: Chronic Myelogenous Leukemia (CML)

FDA Approves Bosulif for Chronic Myelogenous Leukemia

Posted 4 Sep 2012 by Drugs.com

September 4, 2012 – The U.S. Food and Drug Administration today approved Bosulif (bosutinib) to treat chronic myelogenous leukemia (CML), a blood and bone marrow disease that usually affects older adults. An estimated 5,430 men and women will be diagnosed with CML in 2012. Most people with CML have a genetic mutation, called the Philadelphia chromosome, which causes the bone marrow to make an enzyme called tyrosine kinase. This enzyme triggers the development of too many abnormal and unhealthy white blood cells called granulocytes. Granulocytes fight infection. Bosulif is intended for patients with chronic, accelerated or blast phase Philadelphia chromosome positive CML who are resistant to or who cannot tolerate other therapies, including imatinib. Bosulif works by blocking the signal of the tyrosine kinase that promotes the development of abnormal and unhealthy granulocytes. “With ... Read more

Related support groups: Leukemia, Chronic Myelogenous Leukemia (CML)

Leukemia Patients Taking Gleevec Achieve 'Normal' Death Rate

Posted 22 Mar 2011 by Drugs.com

TUESDAY, March 22 – The death rate of patients with chronic myeloid leukemia who took Gleevec and were in remission two years after treatment was similar to the death rate in the general population, a new study shows. Italian researchers collected data on 832 patients who were taking Gleevec (imatinib) for up to eight years and found that 20 patients died during the follow-up period. That death rate of 4.8 percent, however, is similar to what would be expected in the general population. Only six deaths were related to chronic myeloid leukemia (CML), the researchers noted. Serious adverse events such as cardiovascular and digestive problems were reported in 139 patents, but only 27 cases (19 percent) were considered to be related to Gleevec, according to the study. Other adverse events frequently connected to Gleevec included muscle cramps, weakness, edema, skin fragility, diarrhea, and ... Read more

Related support groups: Chronic Myelogenous Leukemia (CML), Gleevec

Study Finds Big Strides Made in Treating Leukemia, Lymphoma in Past Decade

Posted 24 Nov 2010 by Drugs.com

WEDNESDAY, Nov. 24 – Clinicians have made remarkable advances in treating blood cancers with bone marrow and blood stem cell transplants in recent years, significantly reducing the risk of treatment-related complications and death, a new study shows. Between the early 1990s and 2007, there was a 41 percent drop in the overall risk of death in an analysis of more than 2,500 patients treated at Fred Hutchinson Cancer Center in Seattle, a leader in the field of blood cancers and other malignancies. Researchers from the Fred Hutchinson Cancer Center, who conducted the study, also noted dramatic decreases in treatment complications such as infection and organ damage. The study was published in the Nov. 24 issue of the New England Journal of Medicine "We have made enormous strides in understanding this very complex procedure and have yielded quite spectacular results," said study senior ... Read more

Related support groups: Hairy Cell Leukemia, Leukemia, Chronic Myelogenous Leukemia (CML), Lymphoma, Chronic Lymphocytic Leukemia (CLL), Acute Myeloid Leukemia, Non-Hodgkin's Lymphoma, Acute Lymphoblastic Leukemia, Cutaneous T-cell Lymphoma, Follicular Lymphoma, Acute Lymphocytic Leukemia, Hodgkin's Lymphoma, Acute Promyelocytic Leukemia, Acute Nonlymphocytic Leukemia, Infection Prophylaxis, Chronic Lymphocytic Leukemia, Conjunctival Mucosa-Associated Lymphoid Tissue Lymphoma, Chronic Eosinophilic Leukemia, Meningeal Leukemia, Burkitt Lymphoma, Acute Myeloblastic Leukemia

FDA approves additional medical indication for Sprycel

Posted 28 Oct 2010 by Drugs.com

SILVER SPRING, Md., Oct. 28 - The U.S. Food and Drug Administration today approved a new indication for Sprycel (dasatinib) for the treatment of a rare blood cancer when it is first diagnosed. The cancer, called Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP-CML), is a slowly progressing blood and bone marrow disease linked to a genetic abnormality. Sprycel, an oral kinase inhibitor, is believed to inhibit the activity of certain proteins responsible for the growth of cancer cells. The action allows bone marrow to begin reproducing normal red and white blood cells. In June 2006, the FDA granted accelerated approval for Sprycel to treat adults with CP-CML with resistant disease or who were intolerant to prior therapy, including Gleevec (imatinib). The agency converted Sprycel to a regular approval in May 2009, after 24-month follow-up data from earlier ... Read more

Related support groups: Chronic Myelogenous Leukemia (CML), Sprycel, Acute Lymphoblastic Leukemia, Dasatinib

Some With Once-Deadly Leukemia Can Take a Break From Gleevec

Posted 19 Oct 2010 by Drugs.com

TUESDAY, Oct. 19 – A small group of people with chronic myeloid leukemia (CML) who decided to stop taking the cancer drug Gleevec (imatinib) have remained cancer-free two years later, French researchers report. The study, published online Oct. 19 in The Lancet Oncology, is the first to raise the possibility that the drug might go beyond long-term cancer control and offer some patients a possible cure. "We've never really told patients that we have a therapy that can provide a cure for this disease," said one expert, Dr. John Cole, chairman of the department of hematology/oncology at the Ochsner Clinic Foundation in New Orleans. "We've simply never used the 'cure' word." Gleevec – a highly targeted member of a class of drugs called protein-tyrosine kinase inhibitors – was first approved by the U.S. Food and Drug Administration for use against CML in 2001. The medication works by ... Read more

Related support groups: Chronic Myelogenous Leukemia (CML), Gleevec

Novartis International AG (CH) - FDA approves Tasigna for newly diagnosed chronic myeloid leukemia patients, data demonstrate major advance over Glivec

Posted 21 Jun 2010 by Drugs.com

Basel, June 17, 2010 - Following a priority review, the US Food and Drug Administration (FDA) has approved Tasigna (nilotinib) for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase. With this approval, Tasigna becomes the first new therapeutic option for newly diagnosed patients since the introduction of Glivec (imatinib)*, providing a major advance for patients with this blood cancer. The US approval was based on results of the ENESTnd (Evaluating Nilotinib Efficacy and Safety in Clinical Trials of Newly Diagnosed Ph+ CML Patients) Phase III clinical trial, which were published today in The New England Journal of Medicine (NEJM). "With the faster and deeper responses we are seeing with Tasigna, newly diagnosed CML patients will have a new and more effective treatment option," said Hervé Hoppenot, ... Read more

Related support groups: Chronic Myelogenous Leukemia (CML), Tasigna

Newer Drugs Beat Gleevec in Head-to-Head Trials

Posted 7 Jun 2010 by Drugs.com

SATURDAY, June 5 – Two new drugs, dasatinib (Sprycel) and nilotinib (Tasigna), appear better than imatinib (Gleevec) in treating patients with newly diagnosed chronic myeloid leukemia and should be considered as first-line treatments, two new studies show. The findings, which should change clinical practice, are to be presented Saturday at the American Society of Clinical Oncology annual meeting in Chicago and were simultaneously published online June 5 in the New England Journal of Medicine. "Both next-generation inhibitors of BCR-ABL [dasatinib and nilotinib] are superior to Gleevec in treating chronic myeloid leukemia when compared head-to-head after one year of follow-up," said Dr. Charles L. Sawyers, chair of the Human Oncology and Pathogenesis Program at the Howard Hughes Medical Institute at Memorial Sloan-Kettering Cancer Center in New York City and author of an accompanying ... Read more

Related support groups: Chronic Myelogenous Leukemia (CML), Gleevec, Tasigna, Sprycel, Nilotinib, Dasatinib, Imatinib

Stem Cell, Bone Marrow Transplants Both Benefit Leukemia Patients

Posted 1 Feb 2010 by Drugs.com

MONDAY, Feb. 1 – Long-term survival rates are similar for leukemia patients who've had either peripheral blood stem cell (PBSC) or bone marrow transplants, a new European study says. The study began with 329 leukemia patients who received either PBSC or bone marrow transplants from a matched sibling donor between 1995 and 1999. Detailed information was collected on all the patients who survived longer than three years after their transplant. Ten years after transplantation, 49.1 percent of PBSC recipients and 56.5 percent of bone marrow transplant recipients were still alive. Chronic graft versus host disease was more common among PBSC transplant patients (73 percent) than among bone marrow transplant patients (54 percent), and more PBSC recipients needed immunosuppressive treatment five years after transplantation (26 percent vs. 12 percent). But this did not affect the PBSC ... Read more

Related support groups: Leukemia, Chronic Myelogenous Leukemia (CML), Acute Myeloid Leukemia

Study Suggests Way to 'Mop Up' Leukemia Cells

Posted 8 Jan 2010 by Drugs.com

FRIDAY, Jan. 8 – Preliminary research suggests that a vaccine could help reduce the risk of a relapse in some people who take the drug Gleevec to treat chronic myeloid leukemia. "Should this vaccine approach prove to be successful, the ability to get patients off lifelong Gleevec therapy would be a significant advance," Dr. Hyam Levitsky, a professor of oncology, medicine and urology at the Johns Hopkins Kimmel Cancer Center in Baltimore, said in a news release from the center. Imatinib mesylate (Gleevec) treats chronic myeloid leukemia, but can leave some cancerous cells behind. They can cause a relapse. Researchers from the cancer center tested a vaccine on 19 people who had cancerous cells even though they'd taken Gleevec for a year. After about 72 months, the number of cancer cells had declined in 13 people. In seven, the cancer had vanished. Reported side effects of the treatment ... Read more

Related support groups: Chronic Myelogenous Leukemia (CML), Gleevec

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