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Chronic Lymphocytic Leukemia (CLL) News

Related terms: Cancer, Chronic Lymphocytic Leukemia, Leukemia, Chronic Lymphocytic, CLL

Genmab Announces U.S. FDA Approval of Arzerra (ofatumumab) as Extended Treatment for Recurrent or Progressive CLL

Posted 18 days ago by Drugs.com

Copenhagen, Denmark; January 19, 2016 — Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for the use of Arzerra (ofatumumab) for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia (CLL). The application was submitted by Novartis under the ofatumumab collaboration between the two companies. This FDA approval is based on data from an interim analysis from a Phase III study, PROLONG (OMB112517) which evaluated ofatumumab maintenance therapy versus no further treatment in patients with a complete or partial response after second or third line treatment for CLL. "The approval of Arzerra in the U.S. as extended treatment provides patients with relapsed CLL with a ... Read more

Related support groups: Leukemia, Chronic Lymphocytic Leukemia (CLL), Arzerra, Ofatumumab

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, Infection Prophylaxis, Chronic Lymphocytic Leukemia, Acute Promyelocytic Leukemia, Acute Myeloblastic Leukemia, Meningeal 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, Acute Nonlymphocytic Leukemia, Chronic Eosinophilic Leukemia, Acute Promyelocytic Leukemia, Infection Prophylaxis, Chronic Lymphocytic Leukemia, Meningeal Leukemia, Acute Myeloblastic Leukemia

Teva Pharmaceuticals and Eagle Pharmaceuticals Announce FDA Approval of Bendeka (bendamustine hydrochloride) Injection

Posted 10 Dec 2015 by Drugs.com

JERUSALEM & WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Dec. 8, 2015-- Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) and Eagle Pharmaceuticals, Inc. (Nasdaq:EGRX) today announce that the U.S. Food and Drug Administration (FDA) has approved Bendeka, (bendamustine hydrochloride) injection, a liquid, low-volume (50 mL) and short-time 10-minute infusion formulation of bendamustine. Bendeka is approved for the treatment of patients with chronic lymphocytic leukemia (CLL) and for the treatment of patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Efficacy in CLL relative to first-line therapies other than chlorambucil has not been established. “We are thrilled that the FDA has approved Bendeka and are excited for what we believe will be a promising launch with Teva. Importantly, w ... Read more

Related support groups: Chronic Lymphocytic Leukemia (CLL), Non-Hodgkin's Lymphoma, Bendamustine, Bendeka

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), Lymphoma, Basal Cell Carcinoma, Melanoma, Skin Cancer, Chronic Lymphocytic Leukemia (CLL), Ovarian Cancer, Non-Hodgkin's Lymphoma, Acute Myeloid Leukemia, Stomach Cancer, Cutaneous T-cell Lymphoma, Hodgkin's Lymphoma, Acute Lymphoblastic Leukemia, Acute Lymphocytic Leukemia, Soft Tissue Sarcoma, Testicular Cancer

Immune Cell Therapy Shows Promise Against Deadly Blood Cancer

Posted 2 Sep 2015 by Drugs.com

WEDNESDAY, Sept. 2, 2015 – An experimental therapy for chronic lymphocytic leukemia (CLL) that uses a patient's own immune cells may cure some patients and prolong survival in others with the blood cancer, researchers report. The process of creating the therapy, called CTL019, begins with a patient's own T cells, which are a type of white blood cell essential for an immune response. The cells are then reprogrammed to hunt and kill cancer cells. After chemotherapy the patient receives an infusion of the newly engineered cells, the researchers explained. "This is a new, ultra-personalized and precision approach to treating cancer," said lead researcher Dr. David Porter, director of blood and marrow transplantation at the Hospital of the University of Pennsylvania in Philadelphia. CLL is the most common type of adult leukemia, according to background information in the study. Survival is ... Read more

Related support groups: Chronic Lymphocytic Leukemia (CLL)

2 Drugs Show Promise Against Blood Cancers

Posted 30 May 2015 by Drugs.com

SATURDAY, May 30, 2015 – Two new drugs have shown promise in slowing the march of two incurable blood cancers, researchers report. One drug, ibrutinib, appears to greatly improve standard treatment for patients with recurring chronic-lymphocytic leukemia (CLL), the most common adult leukemia in Western countries. Ibrutinib (Imbruvica) reduced the risk of cancer progression or death by 80 percent when combined with a chemotherapy drug called bendamustine (Treanda) and a targeted therapy drug called rituximab (Rituxan), compared to the other two drugs being used on their own, the researchers found. "We found that if you add ibrutinib to the standard regimen, progression-free survival was significantly improved as a direct result of the ibrutinib," said lead author Dr. Asher Chanan-Khan, a professor of medicine at the Mayo Clinic in Jacksonville, Fla. Meanwhile, the second drug, ... Read more

Related support groups: Rituxan, Chronic Lymphocytic Leukemia (CLL), Rituximab, Non-Hodgkin's Lymphoma, Treanda, Bendamustine, Obinutuzumab, Gazyva

FDA Expands Use of Imbruvica for Form of Leukemia

Posted 29 Jul 2014 by Drugs.com

MONDAY, July 28, 2014 – Approved use for Imbruvica (ibrutinib) has been expanded to include people with chronic lymphocytic leukemia (CLL) who have a deletion in chromosome 17, the U.S. Food and Drug Administration said Monday in a news release. People with the 17p deletion are prone to a poor response to standard therapies for CLL, the agency noted. CLL, a form of non-Hodgkin lymphoma, generally gets worse over time and leads to a gradual increase in white blood cells called B lymphocytes. Almost 16,000 Americans will be diagnosed with CLL and 4,600 will die from it this year, the FDA said, citing projections from the U.S. National Cancer Institute. The expanded approval followed a clinical study of 391 people, 127 of whom had the 17p deletion. The trial was stopped early after participants treated with Imbruvica showed a 78 percent reduction in risk of disease progression or death, ... Read more

Related support groups: Chronic Lymphocytic Leukemia (CLL), Imbruvica

FDA Expands Approved Use of Imbruvica for Chronic Lymphocytic Leukemia

Posted 28 Jul 2014 by Drugs.com

July 28, 2014 – The U.S. Food and Drug Administration today expanded the approved use of Imbruvica (ibrutinib) to treat patients with chronic lymphocytic leukemia (CLL) who carry a deletion in chromosome 17 (17p deletion), which is associated with poor responses to standard treatment for CLL. Imbruvica received a breakthrough therapy designation for this use. The FDA is also approving new labeling to reflect that Imbruvica’s clinical benefit in treating CLL has been verified. In February 2014, Imbruvica received accelerated approval to treat CLL based on its effect on overall response rate. New clinical trial results examining progression-free survival and overall survival have confirmed the drug’s clinical benefit. A type of non-Hodgkin lymphoma, CLL is a rare blood and bone marrow disease that usually gets worse slowly over time, causing a gradual increase in white blood cells cal ... Read more

Related support groups: Chronic Lymphocytic Leukemia (CLL), Imbruvica, Ibrutinib

FDA Approves Zydelig (idelalisib) for CLL and Lymphoma

Posted 23 Jul 2014 by Drugs.com

July 23, 2014 – The U.S. Food and Drug Administration today approved Zydelig (idelalisib) to treat patients with three types of blood cancers. Zydelig is being granted traditional approval to treat patients whose chronic lymphocytic leukemia (CLL) has returned (relapsed). Used in combination with Rituxan (rituximab), Zydelig is to be used in patients for whom Rituxan alone would be considered appropriate therapy due to other existing medical conditions (co-morbidities). Zydelig is the fifth new drug with breakthrough therapy designation to be approved by the FDA and the third drug with this designation approved to treat CLL. The FDA is also granting Zydelig accelerated approval to treat patients with relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic lymphoma (SLL), another type of non-Hodgkin lymphoma. Zydelig is intended to be used in patients who ... Read more

Related support groups: Leukemia, Lymphoma, Chronic Lymphocytic Leukemia (CLL), Non-Hodgkin's Lymphoma, Follicular Lymphoma

Zydelig Approved for Three Types of Blood Cancer

Posted 23 Jul 2014 by Drugs.com

WEDNESDAY, July 23, 2014 – Zydelig (idelalisib) has been approved by the U.S. Food and Drug Administration to treat relapsed forms of blood cancer, including chronic lymphocytic leukemia (CLL), follicular B-cell non-Hodgkin lymphoma (FL) and small lymphocytic lymphoma (SLL), the FDA said Wednesday in a news release. The approval for the three forms of blood cancer covers instances when the cancer returns despite treatment with at least one other therapy, the agency said. The drug's label will include a boxed warning that the medication could cause liver toxicity, diarrhea, high blood sugar, elevated liver enzymes, high blood triglycerides [a blood fat] and inflammation of the colon (colitis). Other side effects noted during clinical testing included fever, fatigue, nausea, cough, pneumonia, abdominal pain, chills and rash. Zydelig is marketed by Gilead Sciences, based in Foster City, ... Read more

Related support groups: Lymphoma, Chronic Lymphocytic Leukemia (CLL), Non-Hodgkin's Lymphoma, Follicular Lymphoma

Experimental Drug May Boost Leukemia Survival, Without Chemo

Posted 12 Mar 2014 by Drugs.com

WEDNESDAY, March 12, 2014 – An experimental drug may extend the lives of people with certain hard-to-treat forms of leukemia and lymphoma – without the need for traditional chemotherapy, according to two studies released Wednesday. The drug, called idelalisib, targets a specific enzyme on white blood cells known as B cells. Researchers found that for people with certain forms of recurrent blood cancers, the drug substantially extended the time that patients lived with no tumor progression. One of the trials, of patients with chronic lymphocytic leukemia (CLL), was stopped early because the benefits of idelalisib over standard treatment became so clear. The drug is now up for expedited review by the U.S. Food and Drug Administration (FDA), for possible approval. A cancer researcher not involved in either trial called the CLL results "fantastic." If idelalisib is approved, "I think ... Read more

Related support groups: Leukemia, Lymphoma, Chronic Lymphocytic Leukemia (CLL)

Imbruvica Approval Expanded to Include Chronic Leukemia

Posted 12 Feb 2014 by Drugs.com

WEDNESDAY, Feb. 12, 2014 – U.S. Food and Drug Administration approval of Imbruvica (ibrutinib) has been expanded to include people with chronic lymphocytic leukemia (CLL) who have tried at least one other anti-cancer therapy. CLL progresses slowly, gradually leading to an increase in white blood cells called B lymphocytes. Last year, some 15,680 Americans were diagnosed with CLL and 4,580 died from it, the agency said Wednesday in a news release, citing the National Cancer Institute. Imbruvica was approved last November to treat people with mantle cell lymphoma. Approval for CLL was based on clinical studies involving 48 people, the FDA said. Some 58 percent of participants had their cancer shrink after treatment. Among the most common side effects of the drug were: low blood platelets, diarrhea, bruising, upper respiratory tract infection, fatigue and muscle pain. Imbruvica is ... Read more

Related support groups: Chronic Lymphocytic Leukemia (CLL), Imbruvica, Ibrutinib

FDA Approves Imbruvica to Treat Chronic Lymphocytic Leukemia

Posted 12 Feb 2014 by Drugs.com

February 12, 2014 – The U.S. Food and Drug Administration today expanded the approved use of Imbruvica (ibrutinib) for chronic lymphocytic leukemia (CLL) patients who have received at least one previous therapy. CLL is a rare blood and bone marrow disease that usually gets worse slowly over time, causing a gradual increase in white blood cells called B lymphocytes, or B cells. The National Cancer Institute estimates that 15,680 Americans were diagnosed and 4,580 died from the disease in 2013. Imbruvica works by blocking the enzyme that allows cancer cells to grow and divide. In November 2013, the FDA granted Imbruvica accelerated approval to treat patients with mantle cell lymphoma, a rare and aggressive type of blood cancer, if those patients received at least one prior therapy. “Today’s approval provides an important new treatment option for CLL patients whose cancer has pro ... Read more

Related support groups: Leukemia, Chronic Lymphocytic Leukemia (CLL), Imbruvica, Ibrutinib

FDA Approves Gazyva for Chronic Lymphocytic Leukemia

Posted 3 Nov 2013 by Drugs.com

November 1, 2013 – The U.S. Food and Drug Administration today approved Gazyva (obinutuzumab) for use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukemia (CLL). CLL is a blood and bone marrow disease that usually gets worse slowly. According to the National Cancer Institute, 15,680 Americans will be diagnosed and 4,580 will die from the disease this year. Gazyva works by helping certain cells in the immune system attack cancer cells. Gazyva is intended to be used with chlorambucil, another drug used to treat patients with CLL. Gazyva is the first drug with breakthrough therapy designation to receive FDA approval. This designation was requested by the sponsor and granted soon after the biologic license application to support marketing approval was submitted to the FDA. The FDA can designate a drug a breakthrough therapy at the ... Read more

Related support groups: Leukemia, Chronic Lymphocytic Leukemia (CLL)

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Rituxan, rituximab, Cytoxan, Imbruvica, Treanda, bendamustine, ibrutinib, cyclophosphamide, Leukeran, view more... Arzerra, Privigen, Zydelig, Sandoglobulin, immune globulin intravenous, Campath, Carimune, Carimune NF, fludarabine, Fludara, chlorambucil, obinutuzumab, Gamimune, Octagam, Gammaplex, Bendeka, Gazyva, Gammar IV, Oforta, ofatumumab, Panglobulin, Cytoxan Lyophilized, Gammagard S / D, Panglobulin NF, Flebogamma, Neosar, idelalisib, alemtuzumab, Venoglobulin-S 5%, Gamimune N 5%, Gamimune N 10%, Polygam S / D, Gammar-P IV, Venoglobulin-S 10%, Iveegam En