Leukemia
Genzyme Receives FDA Complete Response Letter for Clolar
October 6, 2009 -- CAMBRIDGE, Mass. – Genzyme Corporation (Nasdaq: GENZ) announced today that the FDA provided a complete response letter regarding the company's supplemental New Drug Application for Clolar® (clofarabine) in previously untreated older adult patients with acute myeloid leukemia (AML) and at least one unfavorable baseline prognostic factor. The agency recommended a randomized, controlled clinical study be conducted for label expansion of Clolar in this indication. » read more »
Novartis Sees Encouraging Results from Tasigna in Leukemia Treatment
Tasigna® shows rapid and deep responses in newly diagnosed patients with a form of chronic myeloid leukemia
Basel, June 5, 2009 - New data show that at 12 months newly diagnosed patients taking Tasigna® (nilotinib) to treat a life-threatening form of chronic myeloid leukemia (CML) had rapid responses and a deep reduction in the amount of the abnormal protein that causes this disease.
"Tasigna now demonstrates potential to achieve remarkable responses in newly diagnosed patients," said Gianantonio Rosti, MD, Institute of Hematology Seràgnoli, Bologna University, Bologna, Italy, and lead study investigator. "These positive data suggest that, one day, Tasigna may offer patients another front-line treatment option." » read more »
GlaxoSmithKline: FDA Advisory Panel Makes Favorable Recommendation For ARZERRA (Ofatumumab)
Orlando FL, 29 May 2009 -- GlaxoSmithKline [NYSE: GSK] and Genmab A/S [OMX: GEN] today announced that the United States Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 10 to three that the ARZERRA™ (ofatumumab) data are reasonably likely to predict clinical benefit for patients with chronic lymphocytic leukemia (CLL) whose disease is refractory to fludarabine and alemtuzumab. Ofatumumab is an investigational treatment. » read more »
Genentech and Biogen Idec Submit Applications to the FDA for Rituxan for Most Common Type of Adult Leukemia
Applications Based on Data from Nearly 1,500 Patients in Two of the Largest Studies Ever Conducted in Chronic Lymphocytic Leukemia
SOUTH SAN FRANCISCO, Calif. and CAMBRIDGE, Mass. – May 19, 2009 – Genentech, Inc. and Biogen Idec (Nasdaq: BIIB) today announced that the companies submitted two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) for Rituxan® (rituximab) plus standard chemotherapy for people with previously untreated or treated chronic lymphocytic leukemia (CLL).
The companies will request a priority review, and if granted, anticipate the FDA will make a decision within six months. » read more »
Scripps Research Team Invents First Technique for Producing Promising Anti-Leukemia Agent
Synthesis Should Boost Research Stalled for More Than a Decade by Inadequate Supplies
LA JOLLA, CA, April 17, 2009—Kapakahines, marine-derived natural products isolated from a South Pacific sponge in trace quantities, have shown anti-leukemia potential, but studies have been all but stalled by kapakahines' lack of availability. But using only acetylene gas, a handful of amino acids, and a dozen inventive steps, a team from The Scripps Research Institute has finally established the first technique to synthesize kapakahines in the laboratory in large quantities, more than a decade after their discovery. With supplies now in hand, and unlimited production potential established, research on the compound can proceed and may eventually lead to new drug treatments. » read more »
Study Finds Heart Failure Is Rare Among Leukemia Patients on Imatinib
6-Sep-2007, HOUSTON - Congestive heart failure rarely occurs among leukemia patients who take imatinib, researchers at The University of Texas M. D. Anderson Cancer Center found after an exhaustive review of the detailed medical histories of 1,276 patients who enrolled in clinical trials for the drug. » read more »
Cancer, Leukemia and Lymphoma Awareness Nights Highlight San Francisco Giants Nine-Game Homestand
08/16/2007, SAN FRANCISCO -- The San Francisco Giants finish a stretch of 31 games in 30 days with a nine-game homestand at AT&T Park. Carlos Zambrano and Aramis Ramirez lead the Chicago Cubs into town for a three-game stint, Aug. 21-23. Prince Fielder and J.J. Hardy of the Milwaukee Brewers follow for a three-game weekend series, Aug. 24-26. The division rival Colorado Rockies come in for their final three-game set of the year in San Francisco, Aug. 27-29. » read more »