Latest Philadelphia chromosome Stories
EAST HANOVER, N.J., Aug. 27 /PRNewswire/ -- Novartis announced today that Gleevec(R) (imatinib mesylate) tablets* has been granted priority review status by the US Food and Drug Administration (FDA) as the first therapy to be reviewed for use after surgery in kit-positive gastrointestinal stromal tumors (GIST). FDA priority review status is granted to therapies that could potentially fill a currently unmet medical need and accelerates the standard review timing from ten to six months(1)....
ChemGenex Pharmaceuticals (ASX:CXS) (NASDAQ:CXSP) announced today that it has submitted the non-clinical section of the rolling submission of a New Drug Application (NDA) for omacetaxine mepesuccinate (formerly known as Ceflatonin(R)) to the U.S. Food and Drug Administration (FDA). "The non-clinical section of the NDA is the first of three parts necessary to complete the NDA submission of omacetaxine and brings us one step closer to commercialization," said Dr. Greg Collier, ChemGenex's...
Exelixis has reported preliminary Phase I data from an ongoing trial of XL228 in patients with chronic myelogenous leukemia or Philadelphia chromosome-positive acute lymphocytic leukemia who are resistant to or intolerant of the approved BCR-ABL inhibitors imatinib and dasatinib. Approximately 17 subjects have received at least one dose of XL228, of whom 16 had completed cycle 1. The trial is evaluating a treatment cycle consisting of four weekly one-hour IV infusions of XL228 at doses...
ChemGenex Pharmaceuticals (ASX:CXS) (NASDAQ:CXSP) announced today the presentation of positive preliminary results from a phase 2 study of omacetaxine mepesuccinate (formerly known as Ceflatonin(R)) in chronic myeloid leukemia (CML) patients who have failed therapy with at least two tyrosine kinase inhibitors (TKIs). These data represent the first findings to be presented from this ongoing study, conducted in patients with or without BCR-ABL mutations. The data presented complement the...
WHITE PLAINS, N.Y., Jun. 22 /PRNewswire-USNewswire/ -- Neil Shah, M.D., PHD, an expert on leukemia, will discuss novel treatment approaches for chronic myelogenous leukemia (CML) in a free telephone workshop entitled The Latest on CML - Update from the American Society of Clinical Oncology (ASCO) Annual Meeting. The program is scheduled for Thursday, Jun. 28, 2007, 12:00 p.m. - 1:30 p.m. ET. Dr. Shah, assistant professor for the division of Hematology/Oncology Department of Medicine at the...
By ED SUSMAN After five years of treatment nearly 90 percent of leukemia patients treated with Gleevec are still alive -- an outcome barely conceivable before the drug was discovered. The Gleevec story truly is a triumph of science over disease, Brian Druker, the lead investigator of the studies with the anti-cancer drug, told United Press International Wednesday. Druker, professor of medicine at the Oregon Health and Sciences University Cancer Center in Portland, said, The results we have...
By Maggie Fox, Health and Science CorrespondentWASHINGTON (Reuters) - Gleevec, the pill that transformed cancer treatments by offering an easy way to target a difficult type of leukemia, may cause serious heart damage, researchers cautioned on Sunday.They found evidence that treatment caused heart failure in 10 patients who took Gleevec, made by Swiss drugmaker Novartis.Patients should not stop taking the drug, known generically as imatinib, but should be watched closely for heart damage, the...
By Maggie Fox, Health and Science CorrespondentWASHINGTON -- Gleevec, the pill that transformed cancer treatments by offering an easy way to target a difficult type of leukemia, may cause serious heart damage, researchers cautioned on Sunday.They found evidence that treatment caused heart failure in 10 patients who took Gleevec, made by Swiss drugmaker Novartis.Patients should not stop taking the drug, known generically as imatinib, but should be watched closely for heart damage, the team at...
WASHINGTON (Reuters) - A new Bristol-Myers Squibb Co. pill won U.S. approval for fighting two types of leukemia in patients running out of treatment options, the company said on Wednesday. The drug called Sprycel was shown to help some patients with chronic myeloid leukemia (CML) that had stopped responding to Novartis AG's pill Gleevec. Bristol-Myers said it expects to have the drug on the market within days. In addition to CML, the FDA approval covers treatment of adults with...
By Gene Emery BOSTON (Reuters) - Two new drugs may help treat some adult cases of leukemia that fail to respond to Novartis AG's Gleevec, two studies showed on Wednesday. One drug, dasatinib, an experimental Bristol-Myers Squibb Co. drug recently endorsed by a Food & Drug Administration advisory panel, could receive full approval by the end of June. Dasatinib helped 68 out of 84 volunteers suffering from a form of chronic myeloid leukemia, or CML, that was resistant to Novartis's...
