Video: Gleevec Receives US Approval as First Treatment To Reduce Risk of Cancer Returning in Patients with Gastrointestinal Stromal Tumors Dec 20, 2008
EAST HANOVER, N.J., Dec. 19 /PRNewswire/ -- Novartis announced today that Gleevec(R) (imatinib mesylate) tablets* has been approved by the US Food and Drug Administration (FDA) for the post-surgery treatment of adult patients following complete surgical removal of Kit (CD117)-positive gastrointestinal stromal tumors (GIST) ... Gleevec is now approved for nine indications, including the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML), Kit (CD117)-positive... (PR Newswire)
Gleevec* leads to longest survival reported for patients with life-threatening form of leukemia, 7-year IRIS data show Dec 11, 2008
In Canada, a conditional marketing authorization has been issued for Gleevec(*) for adult and pediatric patients with newly diagnosed, Philadelphia-chromosome-positive, chronic myeloid leukemia in chronic phase and in adult patients with unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). These authorizations are conditional upon confirmation of clinical benefit. (Canada Newswire)
Gastrointestinal Stromal Tumors: Study May Result In More Targeted Drugs Nov 25, 2008
The study, which focused on gastrointestinal stromal tumors, also called GIST, found that the genetic variations in their disease appear to determine which medications will be most effective ... (May 15, 2008) Excess amounts of a protein called IGF-1R in patients with gastrointestinal stromal tumors could indicate that the patient would be less responsive to Gleevec ... 16, 2004) Not only can positron emission tomography (PET) help evaluate treatment for gastrointestinal stromal tumors (GIST) by... (Science Daily)
OHSU Knight Cancer Institute researcher: study may result in more targeted drugs for GIST Nov 13, 2008
The study, which focused on, gastrointestinal stromal tumors, also called GIST, found that the genetic variations in their disease appear to determine which medications will be most effective. "What these findings mean is that we can begin to develop an individualized approach to the treatment of GIST. We can tailor therapy based on the genetic makeup of the tumor," said Michael Heinrich, M.D., interim head of hematology/medical oncology, and section chief of hematology /medical oncology,... (EurekAlert!)
RIM Co-CEO, Jim Balsillie and Dr. David Malkin of SickKids Hospital Honoured at Israel Cancer Research Fund's First Annual 'Men of Distinction' Award Sep 24, 2008
Heralded by the science community as a miracle drug, basic research that led to the development of Gleevec(R) was funded by the ICRF. Gleevec(R) is manufactured by Novartis for treatment of CML and gastrointestinal stromal tumors (GISTs), a rare form of stomach cancer. Created to bring awareness and much-needed funding to cancer research, ICRF hopes that this distinguished event raises crucial funds that are directed toward the development of further life-saving drugs and treatments for cancer... (Canada Newswire)
Infinity Initiates Clinical Development of IPI-493, Its Oral Anti-Chaperone Agent, in Patients With Advanced Solid Tumors Jul 30, 2008
In addition to starting the Phase 1 trial of IPI-493, Infinity continues to advance its anti-chaperone program, which includes a planned Phase 3 registration study of IPI-504 in patients with refractory gastrointestinal stromal tumors (GIST). IPI-504 is also being evaluated in the Phase 2 portion of a Phase 1 / 2 trial in patients with non-small cell lung cancer and a Phase 1b trial in combination with docetaxel. (Primezone Releases)
GlaxoSmithKline, Exelixis to end 6-year collaboration Jun 28, 2008
GSK can pick an additional compound among six programs: XL184, which will start Phase III trials this summer for glioblastoma, medullary thyroid cancer and non-small cell lung cancer; XL820, in Phase II for gastrointestinal stromal tumor; XL281, in Phase I for patients with advanced solid tumors; XL228, in Phase I for chronic myelogenous leukemia, Philadelphia chromosome-positive acute lymphocytic leukemia and advanced malignancies; or XL844, in Phase I in combination with gemcitabine in... (San Francisco Business Journal)
Cancer Drug Gleevec Linked to Muscle Damage Jun 20, 2008
WEDNESDAY, June 18 (HealthDay News) -- French doctors have reported a possible new side effect associated with the cancer drug Gleevec (imatinib), widely used for the treatment of chronic myeloid leukemia and gastrointestinal stromal tumors. In a letter published in the June 19 issue of the New England Journal of Medicine, the doctors describe the case of a 25-year-old woman who developed severe rhabdomyolysis while taking imatinib. (MEDLINEplus)
Imatinib as a Possible Cause of Severe Rhabdomyolysis Jun 19, 2008
is widely used for the treatment of chronic myeloid leukemia and gastrointestinal stromal tumors. Its common side effects (diarrhea, edema, asthenia, myalgia, and skin reactions) are most often mild and manageable. (New England Journal of Medicine)
Infinity Pharma Drug Shows Response, Moving To Late-Stage Jun 1, 2008
Based on the results, Infinity will initiate a Phase III registration trial of the drug in advanced gastrointestinal stromal tumors, or GIST, under a Special Protocol Assessment agreement with the Food and Drug Administration. A Special Protocol Assessment, or SPA, is an agreement with the FDA on the design of a study to meet the requirements for a new drug application. (CNNMoney.com)
Infinity, Astra Feel Need For Speed Jun 1, 2008
Gastrointestinal stromal tumors (GIST) were first attacked by Novartis' (nyse: - - ) Gleevec, a $2-billion-a-year drug mostly used to treat leukemia. But the average GIST tumor becomes resistant to Gleevec in 18 months, though the drug can keep working for years in some people, Adams says. (Forbes -- Business)
Abnormalities In Gene For Melanoma Found May 31, 2008
ScienceDaily (May 30, 2008) New research from the Oregon Health & Science University Cancer Institute about mutations in melanoma may bring a wellspring of hope to many patients. Researchers have discovered that there are several different kinds of DNA abnormalities that can occur in a gene called the KIT gene. (Science Daily)
Infinity Announces Clinical Data Confirming Activity and Safety of IPI-504, a Novel Hsp90 Inhibitor, in Patients With Refractory GIST May 31, 2008
May 31, 2008 (PRIME NEWSWIRE) -- Infinity Pharmaceuticals, Inc. (NasdaqGM: - ) today announced positive results from a Phase 1 clinical trial of IPI-504, the company's lead Hsp90 inhibitor, in patients with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) refractory to tyrosine kinase inhibitors ... About Gastrointestinal Stromal Tumors (GIST) and Hsp90. (Primezone Releases)
Bayer and Onyx Announce Nexavar Data Presentations at 44th American Society of Clinical Oncology Annual Meeting May 16, 2008
Poster discussion period: 11:00 AM - 12:00 p.m., W375a -- Comparison of kidney cancer symptoms and quality of life (QoL) in renal cell cancer (RCC) patients receiving sorafenib vs. interferon-a (IFN) -- Cezary Szczylik, MD, Central Clinical Hospital, Military Institute of Health, Warsaw, Poland -- Poster 44E, Abstract #9603, Saturday, May 31, 2008, 2:00 - 6:00 p.m., S Hall A1 -- Updated results of a Phase I trial of sorafenib and bevacizumab in patients with metastatic renal cell carcinoma (RCC)... (PR Newswire)
Infinity Announces Oral Presentation of Results From Clinical Trial of IPI-504 in Patients With GIST At ASCO Annual Meeting May 16, 2008
May 16, 2008 (PRIME NEWSWIRE) -- Infinity Pharmaceuticals, Inc. (NasdaqGM: - ), an innovative cancer drug discovery and development company, today announced that updated results from a Phase 1 study of the company's lead inhibitor of heat shock protein 90, IPI-504, in patients with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) or other advanced soft tissue sarcomas, will be presented at the 2008 Annual Meeting of the American Society of Clinical Oncology (ASCO) ...... (Primezone Releases)
Protein predicts Gleevec resistance in gastrointestinal tumors May 16, 2008
Excess amounts of a protein called IGF-1R in patients with gastrointestinal stromal tumors (GISTs) could indicate that the patient would be less responsive to the drug imatinib mesylate (known as Gleevec), according to Andrew K. Godwin, Ph ... A small percentage of adult gastrointestinal stromal tumors and most pediatric cases are often less responsive to Gleevec, says Godwin, Director of Fox Chase's Clinical Molecular Genetics Laboratory. (EurekAlert!)
Infinity Highlights Promising Preclinical Hedgehog Data and Announces First Quarter Financial Results May 5, 2008
presented new preclinical data on its wholly-owned lead Hedgehog pathway inhibitor, IPI-926, demonstrating significant anti-tumor activity in multiple disease models; * presented new preclinical data, in collaboration with MedImmune, a unit of AstraZeneca, (MedImmune/AZ) on the companies' lead heat shock protein 90 (Hsp90) inhibitor, retaspimycin hydrochloride ("retaspimycin," also known as IPI-504), demonstrating the compound's activity in drug-resistant non-small cell lung cancer and in... (Primezone Releases)
First Targeted Therapy To Produce Remission Of Metastatic Melanoma Apr 22, 2008
Imatinib's effectiveness against tumors with KIT mutations was first demonstrated in gastrointestinal stromal tumors (GISTs), a relatively rare malignancy of the digestive tract. An estimated 75-80 percent of GISTs have KIT mutations, and Imatinib has caused such tumors to stabilize or retreat in 75-90 percent of patients receiving it. (Science Daily)
New Data On Infinity's Lead Anti-Cancer Candidates to be Presented At AACR Apr 7, 2008
The drug product, retaspimycin hydrochloride for injection, has shown promising biological activity in a Phase 1 clinical trial in patients with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) and the Phase 1 portion of a Phase 1/2 study in patients with advanced non-small cell lung cancer (NSCLC). Retaspimycin is also being evaluated in Phase 2 studies in patients with NSCLC and hormone-refractory prostate cancer, as well as in a Phase 1b study in combination with... (Primezone Releases)
SPECIAL REPORT: Drug markers questioned Apr 2, 2008
It is a wonderful drug which has revolutionised the way chronic myeloid leukemia (CML) and gastrointestinal stromal tumor (GIST) are managed. I do agree that the newer anticancer drugs are being tested using surrogate endpoints and not necessarily survival, which is the most robust efficacy assessment tool. (Nature News Service)
Positron Emission Tomography Superior To Standard Evaluation Tools In Measuring Treatment Response Feb 6, 2008
16, 2004) Not only can positron emission tomography (PET) help evaluate treatment for gastrointestinal stromal tumors (GIST) by revealing biologic changes such as how the tumor processes the fuel that makes it. . (Science Daily)
Infinity and MedImmune Announce Approval for Generic Name for Novel Hsp90 Inhibitor Feb 4, 2008
Retaspimycin hydrochloride is currently being evaluated in clinical trials for the potential treatment of a variety of solid tumor cancers, including gastrointestinal stromal tumors, non-small cell lung cancer, and hormone resistant prostate cancer ... The drug product, retaspimycin hydrochloride for injection, has been generally well-tolerated and has shown promising biological activity in Phase 1 clinical trials in patients with metastatic and/or unresectable gastrointestinal stromal tumors... (Primezone Releases)
Infinity and MedImmune Initiate Phase 1b Trial of IPI-504 in Combination With Taxotere in Patients With Advanced Solid Tumor Cancers Jan 4, 2008
IPI-504 has shown promising biological activity and been well-tolerated in Phase 1 clinical trials in patients with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) and patients with advanced non-small cell lung cancer (NSCLC). The Phase 2 single-agent dose and schedule of IPI-504 has been established as 400 mg/m2 on a three-week cycle, consisting of twice-weekly treatment for two weeks followed by one week off treatment. (Primezone Releases)
Scientists Reveal Role Of Gene In Sensitivity To Thermal Pain Dec 16, 2007
The researchers attained similar results by administering Gleevec (imatinib), a drug that a few years ago revolutionized the treatment of breast cancer, leukemias and gastrointestinal stromal tumors, but also can apparently alleviate pain. Gleevec blocks a specific group of proteins to which c-Kit also belongs. (Science Daily)
Another 'smart' cancer drug can have toxic effects on the heart Dec 14, 2007
However, a new retrospective analysis, focused on cardiovascular events, revealed a risk for heart failure, myocardial infarction and hypertension in 75 adult patients with imatinib-resistant, gastrointestinal stromal tumor (GIST) receiving multiple cycles of sunitinib in a phase I/II trial at Dana-Farber. Of the 75, six (8 percent) developed symptoms consistent with moderate-to-severe congestive heart failure, and two had heart attacks. (EurekAlert!)
Gleevec, the targeted cancer pill, delivers more good news to patients Dec 10, 2007
Gleevec has also been approved for the treatment of gastrointestinal stromal tumors, pediatric CML, as well as five additional rare cancers. . (EurekAlert!)
Re-engineered Gleevec Reduces Heart Risks, Study Suggests Dec 6, 2007
The new study reports pre-clinical evidence that the newly re-engineered drug is just as effective as imatinib against gastrointestinal stromal tumor (GIST) and carries significantly less risk of heart failure. Developed by Novartis Pharmaceuticals, Gleevec is approved by the U.S. Food and Drug Administration for the treatment of chronic myeloid leukemia (CML), Philadelphia-chromosome positive acute lymphoblastic leukemia and GIST. The drug targets two proteins that have been linked with cancer. (Science Daily)
Rice, M.D. Anderson collaborate on anticancer drug Dec 5, 2007
The new study, which appears in the Dec. 3 issue of the Journal of Clinical Investigation, reports pre-clinical evidence that the newly re-engineered drug is as effective as imatinib against gastrointestinal stromal tumor and carries significantly less risk of heart failure. Developed by , Gleevec is approved by the for the treatment of certain types of leukemia -- cancer of the blood -- as well as the gastrointestinal cancer. (Houston Business Journal, TX)
Infinity Announces Hedgehog Pathway Inhibitor Agreement With AstraZeneca Nov 12, 2007
The companies' lead Hsp90 inhibitor, IPI-504, has demonstrated evidence of biological activity in both gastrointestinal stromal tumors (GIST) and in non-small cell lung cancer (NSCLC). The companies expect to launch Phase 2 trials of IPI-504 as a single agent in additional tumors, as well as at least one combination study, before the end of 2007. (Primezone Releases)
PHARMA MARKET: First Out Of Gate, Nexavar Loses Ground Nov 11, 2007
These include Sutent's approved use to treat gastrointestinal stromal tumors. Wyeth's (WYE) Torisel, which received U.S. Food and Drug Administration approval to treat kidney cancer in May, had sales of $10 million for the third quarter, its first full quarter on the market. (CNNMoney.com)
OHSU turns innovations into commercial opportunities at record pace Oct 24, 2007
Heinrich was the first to identify mutations in platelet-derived growth factor receptors (PDGFR) as the cause of gastrointestinal stromal tumors in specific patient populations. MolecularMDs focus is on developing partnerships with pharmaceutical companies and physicians by providing them with clinically relevant molecular tests that help optimize therapy and improve patient outcomes. (EurekAlert! -- Business News)
Tyrosine Kinase Inhibitors for CML Oct 11, 2007
Hypothyroidism has been reported in patients treated with imatinib for metastatic medullary thyroid carcinoma or gastrointestinal stromal tumors (GIST). 2 An increase in levothyroxine replacement was necessary in some patients who had previously undergone a thyroidectomy. (New England Journal of Medicine)
Couple escapes burning truck without injury Oct 6, 2007
Last March, doctors found a malignant gastrointestinal stromal tumor in Ted s abdomen which could not be treated with chemotherapy. After surgery, doctors informed the Susans that the cancer had metastasized and spread; meaning Ted could live about a year unless cancer therapy drugs were effective. (Gaylord Herald Times, MI)
Mets reach out to longtime fan Sep 27, 2007
Sadie went to the doctor to learn that the gastrointestinal stromal tumors -- a cancer so rare her oncologist deemed her "a celebrity" -- she had beaten once before had returned to her system. The surgeon reviewing her MRI said the disease had spread to her liver, pelvis and abdominal wall. (MLB.com -- NY Mets Mets)
Thailand may override patents on some cancer drugs Sep 24, 2007
Imanitib, marketed by Novartis as Gleevec in the United States and Glivec in Europe, is used to treat leukaemia and gastrointestinal stromal tumors. Docetaxel, sold as Taxotere by Sanofi-Aventis, is used to treat lung cancer, ovarian cancer and breast cancers, while Erlotinib, marketed as Tarceva by Roche, is used to treat lung, pancreatic and other types of cancers. (Inquirer.net)
Cadence Pharmaceuticals Names Malvina Laudicina Vice President of Regulatory Affairs and Quality Assurance Sep 14, 2007
Also at Pfizer, as Executive Director and Regulatory Site Head, she had responsibility for four therapeutic areas and led the regulatory team responsible for the registration of Sutent(R) (sunitinib malate), a drug approved by the U.S. Food and Drug Administration (FDA) for the treatment of advanced kidney cancer and gastrointestinal stromal tumors. Prior to Pfizer, Ms. Laudicina held senior regulatory and clinical research positions at Prometheus Laboratories, Dura Pharmaceuticals and... (PR Newswire)
Study finds heart failure is rare among leukemia patients on imatinib Sep 7, 2007
Imatinib, known by its brand name Gleevec(tm) and developed by Novartis Pharmaceuticals, is approved by the U.S. Food and Drug Administration for the treatment of chronic myelogenous leukemia (CML), Philadelphia-chromosome positive acute lymphoblastic leukemia d(ALL) and gastrointestinal stromal tumor, a rare solid tumor cancer. Imatinib is a targeted therapy that inhibits two members of a class of enzymes called tyrosine kinases, which transmit growth and survival signals in cells. (EurekAlert!)
Familial Gastrointestinal Stromal Tumors and Germ-Line Mutations Sep 6, 2007
To the Editor: Gastrointestinal stromal tumors may be sporadic or inherited in an autosomal dominant manner, alone or as a component of a syndrome associated with other tumors, such as in the context of neurofibromatosis type 1. 1 We have described seven male and five female patients (median age, 23 years) from five unrelated families who had both gastrointestinal stromal tumors and paragangliomas ... 2 This condition has been referred to as "the dyad of paraganglioma and gastrointestinal... (New England Journal of Medicine)
Dr. Amit Dhawan Promoted to Medical Director for The Mattson Jack Group Aug 21, 2007
Executive Vice President Jerry Fields commented, "Dr, Dhawan is a highly regarded individual who brings a unique combination of scientific and commercial perspectives together to help solve client problems. Our clients benefit from his exceptional knowledge and insight. About The Mattson Jack Group, Inc. () Formed in 1986, MattsonJack focuses its client support in three areas of Competency: Business Analytics, Brand Optimization, and Corporate Development services in the pharmaceutical and... (PR Newswire)
First Detailed View Of Molecular Structure May Usher In New Class Of Cancer Drugs Aug 8, 2007
It is also anticipated that the new family of drugs may be applied for the treatment of gastrointestinal stromal tumor (GIST) cancers that are resistant to Gleevec and Sutent. Although these drugs would target the same receptors as Gleevec and Sutent, they would do so by a different mechanism and may therefore be useful for patients who are resistant to these drugs. (Science Daily)
Paul Schaye is used to conquering physical challenges. So it's no surprise how he feels about his cancer. Aug 1, 2007
Last October, he was diagnosed with a rare form of stomach cancer called gastrointestinal stromal tumor. A tumor larger than a baseball was growing in his stomach. (Boston Globe)
Pfizer Inc UK Regulatory Announcement: Pfizer's Lyrica Receives FDA Approval for Fibromyalgia Based on Expedited Review Jun 22, 2007
In addition to Lyrica s initial approval for the management of neuropathic pain associated with diabetic peripheral neuropathy, other priority reviews included Sutent for advanced kidney cancer and gastrointestinal stromal tumors and Chantix for smoking cessation. Pfizer undertook a robust clinical development program to evaluate Lyrica s effectiveness in treating a number of conditions where there is a huge unmet medical need, said Joe Feczko, Pfizer s chief medical officer. (BusinessWire)
ChemGenex reports successful personalized dosing of Quinamed at ASCO Jun 5, 2007
One patient with gastrointestinal stromal tumor (GIST) demonstrated stable disease which was sustained over 18 monthly cycles of amonafide. Greg Collier, Ph. (EurekAlert!)
Pfizer Inc UK Regulatory Announcement: New Data Evaluating SUTENT, CP-751,871 and Axitinib in Patients with Non-Small Cell Lung Cancer Jun 4, 2007
SUTENT is a multi-kinase inhibitor approved for the treatment of advanced renal cell carcinoma (RCC) and gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. Women of child bearing age who are (or become) pregnant during therapy should be informed of the potential for fetal harm while on SUTENT.. (BusinessWire)
Infinity Announces First Quarter Results and Highlights Recent Accomplishments May 1, 2007
-- The initiation of a Phase I/II clinical trial of IPI-504, Infinity's lead anticancer agent, in non-small cell lung cancer (NSCLC) -- Continued evidence of safety, tolerability, and biological activity of IPI-504 in patients with gastrointestinal stromal tumors (GIST) in data presented at the American Society for Clinical Oncology Gastrointestinal Symposium (ASCO GI) -- Demonstration of bioavailability and preclinical efficacy for the oral formulation of IPI-504 in NSCLC as presented at the... (Primezone Releases)
Gleevec reduces recurrence in colon cancer Apr 17, 2007
The large national clinical trial, led by Dr. Ronald DeMatteo, of Memorial Sloan-Kettering Cancer Center, and conducted by a national network of researchers, treated patients with primary gastrointestinal stromal tumor (GIST), a type of tumor usually found in the stomach or small intestine. They released the early results because the study had met is primary objective of increasing recurrence-free survival. (Cancerfacts.com)
Gleevec keeps stomach tumor at bay: study Apr 13, 2007
The National Institutes of Health-funded team found that 97 per cent of patients with a stomach cancer called gastrointestinal stromal tumor of GIST who took Gleevec for one year remained cancer-free after surgery as compared to 83 percent of patients given a placebo ... The American Cancer Society says it is not known how many new gastrointestinal stromal tumors are diagnosed each year but estimated that around 1,500 malignant cases occur in the United States. (Scientific American)
Gleevec decreases cancer recurrence for patients with primary gastrointestinal stromal tumor Apr 13, 2007
Preliminary results from a large, randomized, placebo-controlled clinical trial for patients with primary gastrointestinal stromal tumor (GIST), a type of tumor usually found in the stomach or small intestine, showed that patients who received imatinib mesylate (Gleevec ) after complete removal of their tumor were significantly less likely to have a recurrence of their cancer compared to those who did not receive imatinib ... Z9001: A Phase III Randomized Double-blind Study of Adjuvant STI571... (EurekAlert!)
Sunitinib and Hypothyroidism Apr 12, 2007
3,4,5 In our group of 65 patients who were treated with sunitinib for renal-cell carcinoma or gastrointestinal stromal tumors, the. . (New England Journal of Medicine)
FDA CAPSULES Feb 13, 2007
Cardiac events with Gleevec, a drug used to treat chronic myeloid leukemia and gastrointestinal stromal tumors. Avoiding burns from electrodes and cables during MRI exams. (Newsday -- Health)
Infinity Announces Fourth Quarter and Year End 2006 Results Feb 8, 2007
Evidence of biological activity of IPI-504, Infinity's lead anticancer agent, in a Phase I clinical trial in patients with gastrointestinal stromal tumors (GIST) * Establishment of a worldwide collaboration with MedImmune, Inc. around Infinity's two lead programs, inhibitors of heat shock protein 90 (Hsp90) and the Hedgehog cell-signaling pathway * Establishment of a worldwide collaboration with Novartis on Infinity's Bcl-2 inhibitor program * Extension of a license agreement by Amgen for... (Primezone Releases)
