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Chronic Myelogenous Leukemia (CML) News

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

FDA Approves Pfizer’s Bosulif (bosutinib) for the Treatment of Patients with Newly-Diagnosed Ph+ Chronic Myelogenous Leukemia (CML)

Posted 14 days ago by Drugs.com

December 19, 2017 – Pfizer Inc. (NYSE:PFE) today announced the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to expand the indication for Bosulif (bosutinib) to include adult patients with newly-diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML). The sNDA was reviewed and approved under the FDA’s Priority Review and accelerated approval programs based on molecular and cytogenetic response rates. Continued approval for this indication may be contingent upon verification and confirmation of clinical benefit in an ongoing long-term follow up trial. Bosulif was first approved in September 2012 in the U.S. for the treatment of adult patients with chronic, accelerated or blast phase Ph+ CML with resistance or intolerance to prior therapy. “Bosulif was Pfizer’s first treatment for hematologic malig ... Read more

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

FDA Updates the Label of Tasigna to Reflect that Certain Patients with a Type of Leukemia May be Eligible to Stop Treatment After Sustained Response

Posted 30 Dec 2017 by Drugs.com

December 22, 2017 – The U.S. Food and Drug Administration today updated the product label for the cancer drug Tasigna (nilotinib) to include information for providers about how to discontinue the drug in certain patients. Tasigna, first approved by the FDA in 2007, is indicated for the treatment of patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML). With today’s updated dosing recommendations, patients with early (chronic) phase CML who have been taking Tasigna for three years or more, and whose leukemia has responded to treatment according to specific criteria as detected by a test that has received FDA marketing authorization, may be eligible to stop taking Tasigna. “Patients diagnosed with CML generally face a lifetime of treatment to keep their leukemia from growing or recurring,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Ex ... Read more

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

FDA Expands Approval of Sprycel (dasatinib) to Include Treatment of Children with Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Chronic Phase

Posted 16 Nov 2017 by Drugs.com

PRINCETON, N.J.--(BUSINESS WIRE) November 10, 2017 --Bristol-Myers Squibb Company (NYSE:BMY) today announced the U.S. Food and Drug Administration (FDA) has expanded the indication for Sprycel (dasatinib) tablets to include the treatment of children with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).1 This approval for Sprycel in pediatric patients with Ph+ CML in chronic phase was granted under priority review, and the indication received orphan drug designation from the FDA. The safety and efficacy of Sprycel in pediatric patients was evaluated in two pediatric studies of 97 patients with CP-CML: an open-label, non-randomized, dose-ranging trial (NCT00306202) and an open-label, non-randomized, single-arm trial (NCT00777036). Among the 97 patients in the two studies, 51 patients (exclusively from the single-arm trial) had newly diagnosed ... Read more

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

Can Drug Company Perks Sway Cancer Docs' Prescriptions?

Posted 6 Jun 2017 by Drugs.com

TUESDAY, June 6, 2017 – Cancer doctors who receive freebies from pharmaceutical companies are more likely to prescribe drugs produced by those companies, a new study reports. Free meals, paid travel expenses and fees for consulting or lecturing appeared to influence which drugs a doctor would choose when treating two different types of cancer, said study lead researcher Dr. Aaron Mitchell. Specifically, doctors were 78 percent more likely to prescribe a drug to treat kidney cancer that had spread if they'd received a gift or small payment from that drug's manufacturer, compared to physicians who didn't receive any payments, Mitchell said. The doctors also were 29 percent more likely to prescribe a drug for chronic myeloid leukemia if they'd received meals, travel or speaking fees from the drug's maker, Mitchell said. "This raises the possibility that drug companies are able to ... Read more

Related support groups: Cancer, Breast Cancer, Chronic Myelogenous Leukemia (CML), Lung Cancer, Colorectal Cancer

Cancer Drug, Dasatinib, Helps Some Kids With Rare Type of Leukemia

Posted 5 Jun 2017 by Drugs.com

MONDAY, June 5, 2017 – The cancer drug dasatinib shows promise in treating children with chronic myeloid leukemia (CML) caused by the gene BCR-ABL, also known as the Philadelphia chromosome, researchers report. "Despite the fact that there is a common molecular driver – BCR-ABL – for this disease in adults and in children, the manifestation in children is different. Pediatric patients tend to have more aggressive disease," said study senior author Dr. Lia Gore. She is co-director of the University of Colorado Cancer Center's Hematological Malignancies Program. "What we saw from the patients we enrolled at Children's Hospital Colorado and around the world was that patients had great disease control, minimal toxicities and were really able to move into normal activities, a normal daily life," Gore said in a university news release. "One of our long-term patients is in college now and ... Read more

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

Gleevec Keeps a Leukemia in Check for More Than a Decade: Study

Posted 9 Mar 2017 by Drugs.com

WEDNESDAY, March 8, 2017 – The cancer drug Gleevec appears to keep chronic myeloid leukemia at bay a decade into treatment – with no signs of additional safety risks, a new study finds. Gleevec – known generically as imatinib – was hailed as a "wonder drug" when it was introduced in 2001 for treating chronic myeloid leukemia (CML). CML is a type of blood cancer that strikes about 5,000 Americans each year, according to the U.S. National Cancer Institute (NCI). Before Gleevec, a CML diagnosis "amounted to a death sentence," the institute said. Now, most cases can be controlled, with either Gleevec or related drugs that have been developed since then. The new findings offer more evidence that the early "hype" around Gleevec was correct, said lead researcher Dr. Andreas Hochhaus, of Jena University Hospital in Germany. Of more than 500 CML patients given Gleevec as their initial ... Read more

Related support groups: Leukemia, Chronic Myelogenous Leukemia (CML), Lung Cancer, Gleevec, Non-Small Cell Lung Cancer, Melanoma, Chronic Lymphocytic Leukemia (CLL), Tasigna, Sprycel, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Imatinib, Dasatinib, Nilotinib, Acute Lymphocytic Leukemia, Acute Myeloblastic Leukemia

Generic Gleevec Will Likely Cut Millions in Health Costs

Posted 19 Mar 2016 by Drugs.com

FRIDAY, March 18, 2016 – Using the generic form of the cancer drug Gleevec could save patients and insurers millions of dollars, a new study suggests. The patent on Gleevec expired in January. The generic version of the drug is called imatinib. The drug is used to treat chronic myeloid leukemia. Most people with chronic myeloid leukemia require lifelong daily medication, researchers said. "If we start all patients on the generic form of Gleevec and it works, then they are on a generic for the rest of their lives," study leader William Padula, an assistant professor at the Johns Hopkins Bloomberg School of Public Health in Baltimore, said in a school news release. "This amounts to a huge cost savings for them and their insurers." The researchers calculated that if all chronic myeloid leukemia patients began receiving imatinib immediately after diagnosis, the cost of treatment per ... Read more

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

New Immune Therapy Achieves Complete Remission in Blood Cancer Patients

Posted 16 Feb 2016 by Drugs.com

A new therapy that uses a person's immune system to attack tumors led to complete remission in terminally ill blood cancer patients, according to researchers. In a clinical trial, symptoms vanished in 94 percent of leukemia patients who received the treatment. The response rate was more than 80 percent in patients with other blood cancers, and half achieved total remission, CNBC reported. The results were presented Monday at the annual meeting of the American Association for the Advancement of Science. Detailed data will be published later this year. They therapy involves removing immune system T-cells from patients, loading them with anti-cancer molecules, and placing them back in the body. The altered T-cells then seek and destroy cancer, CNBC reported. The results are unprecedented, according to researcher Stanley Riddell. "In the laboratory and in clinical trials, we are seeing ... Read more

Related support groups: Blood Disorders, Cancer, Hairy Cell Leukemia, Leukemia, Chronic Myelogenous Leukemia (CML), Chronic Lymphocytic Leukemia (CLL), Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Diagnosis and Investigation, Acute Lymphocytic Leukemia, Chronic Eosinophilic Leukemia, Acute Nonlymphocytic Leukemia, Acute Promyelocytic Leukemia, Acute Myeloblastic Leukemia, Infection Prophylaxis, Chronic Lymphocytic Leukemia, Meningeal Leukemia

Antibody May Lower Rejection Rates After Stem Cell Transplant in Leukemia Patients

Posted 7 Jan 2016 by Drugs.com

WEDNESDAY, Jan. 6, 2016 – People with acute leukemia who were given antibody therapy before a stem cell transplant fared better than those who didn't receive the treatment, a small study found. Stem cell transplantation allows doctors to give higher doses of cancer-killing chemotherapy, according to the American Cancer Society. However, the odds of the body rejecting the transplanted stem cells are very high – a condition called graft-versus-host disease, the study authors explained. By treating patients first with animal-derived antibodies, called antihuman T-lymphocyte immune globulin (ATG), the researchers were able to lower the threat of rejection in patients. "Graft-versus-host disease is the most serious complication after stem cell transplantation," said lead researcher Dr. Francesca Bonifazi, from the Institute of Hematology at Bologna University in Italy. "Using [ATG] reduces ... Read more

Related support groups: Hairy Cell Leukemia, Leukemia, Chronic Myelogenous Leukemia (CML), Chronic Lymphocytic Leukemia (CLL), Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Acute Lymphocytic Leukemia, Acute Nonlymphocytic Leukemia, Chronic Eosinophilic Leukemia, Acute Promyelocytic Leukemia, Infection Prophylaxis, Chronic Lymphocytic Leukemia, Meningeal Leukemia, Acute Myeloblastic Leukemia

End-of-Life Talk Often Comes Too Late for Blood Cancer Patients

Posted 21 Dec 2015 by Drugs.com

MONDAY, Dec. 21, 2015 – Many doctors wait too long to have end-of-life discussions with blood cancer patients, a new study finds. Researchers analyzed surveys completed by 349 blood cancer specialists, and found that 56 percent said end-of-life discussions with patients happen too late. Nearly 43 percent said they had their first end-of-life discussions with patients at less-than-ideal times, the findings showed. About 23 percent of the doctors said they waited until death was imminent before discussing hospice care. And nearly 40 percent waited until death was imminent before they asked patients where they wanted to die. Several factors may contribute to the delay in end-of-life discussions with blood cancer patients, according to Dr. Oreofe Odejide, from the Dana-Farber Cancer Institute in Boston, and colleagues. While solid tumors are incurable after they reach an advanced stage, ... Read more

Related support groups: Cancer, Hairy Cell Leukemia, Leukemia, Chronic Myelogenous Leukemia (CML), Chronic Lymphocytic Leukemia (CLL), Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Acute Lymphocytic Leukemia, Chronic Eosinophilic Leukemia, Acute Nonlymphocytic Leukemia, Acute Promyelocytic Leukemia, Acute Myeloblastic Leukemia, Infection Prophylaxis, Chronic Lymphocytic Leukemia, Meningeal Leukemia

Sun Pharma Announces FDA Approval for Generic Gleevec

Posted 6 Dec 2015 by Drugs.com

Mumbai, December 04, 2015: Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, Sun Pharma) today announced that one of its subsidiaries has received final approval from US FDA for its Abbreviated New Drug Application (ANDA) for generic version of Gleevec, Imatinib Mesylate tablets 100mg and 400mg. Imatinib Mesylate tablets, 100 mg and 400 mg are therapeutic equivalents of Novartis’ Gleevec tablets. As per IMS MAT August 2015, these tablets have annual sales of approximately US$ 2.5 billion in the US. These tablets are indicated for the treatment of chronic myeloid leukemia. The Sun Pharma subsidiary, being the first-to-file an ANDA for generic Gleevec with a para IV certification, is eligible for 180-days marketing exclusivity in the US. Under the terms of a settlement agreement with Novartis, the Sun Pharma subsidiary is permitted to l ... Read more

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

Young Cancer Survivors Often Develop New Malignancies

Posted 6 Oct 2015 by Drugs.com

TUESDAY, Oct. 6, 2015 – Teen and young adult cancer survivors are at increased risk for other cancers later in life, a new study reveals. Researchers analyzed U.S. National Cancer Institute data on people who survived cancers before age 40. They had the most common types of cancers in that age group: leukemia, lymphoma, testicular, ovarian, thyroid, breast, soft tissue and bone cancers. "This is a patient demographic that has been largely overlooked," said senior study author Dr. Robert Goldsby, a professor of pediatrics at the University of California, San Francisco Benioff Children's Hospital. Over 30 years, nearly 14 percent of the survivors were diagnosed with another, different type of cancer. On average, the second cancer occurred within 15 years. Compared to people in the general population, patients successfully treated for cancer between ages 15 and 39 were nearly 60 percent ... Read more

Related support groups: Cancer, Breast Cancer, Hairy Cell Leukemia, Leukemia, Chronic Myelogenous Leukemia (CML), Basal Cell Carcinoma, Lymphoma, Skin Cancer, Melanoma, Chronic Lymphocytic Leukemia (CLL), Ovarian Cancer, Non-Hodgkin's Lymphoma, Acute Myeloid Leukemia, Stomach Cancer, Acute Lymphoblastic Leukemia, Hodgkin's Lymphoma, Cutaneous T-cell Lymphoma, Testicular Cancer, Mantle Cell Lymphoma, Soft Tissue Sarcoma

Could Common Diabetes Drugs Help Fight Leukemia?

Posted 2 Sep 2015 by Drugs.com

WEDNESDAY, Sept. 2, 2015 – Common diabetes drugs might help eradicate drug-resistant cancer cells in a certain form of leukemia when added to standard treatment, a small new study suggests. Researchers found that patients with chronic myeloid leukemia (CML) who received a glitazone – a class of drug for type 2 diabetes – along with the standard CML drug imatinib remained disease-free for up to nearly five years. Imatinib, known commercially as Gleevec, boasts an impressive track record in controlling chronic myeloid leukemia and allowing patients to lead virtually normal lives. But despite its effectiveness, dormant, drug-resistant leukemic cells typically lay in wait in bone marrow. They can later transform into highly aggressive cells. "Gleevec can control the disease but never get rid of the source of the disease," said Lee Greenberger, chief scientific officer for the Leukemia & ... Read more

Related support groups: Chronic Myelogenous Leukemia (CML), Gleevec, Actos, Pioglitazone, Avandia, Imatinib, ActoPlus Met, Metformin/Pioglitazone, Rosiglitazone, Alogliptin/pioglitazone, Glimepiride/Pioglitazone, ActosPlus Met, Avandaryl, Metformin/Rosiglitazone, Duetact, Oseni, Glimepiride/Rosiglitazone, Avandamet

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)

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Gleevec, Tasigna, Sprycel, hydroxyurea, Hydrea, cyclophosphamide, anagrelide, imatinib, dasatinib, view more... nilotinib, cytarabine, Bosulif, Agrylin, Iclusig, bosutinib, peginterferon alfa-2b, interferon alfa-2a, ponatinib, Busulfex, Myleran, busulfan, fludarabine, Synribo, omacetaxine