Imatinib mesylate (also called Gleevec® or STI571) is approved by the U.S. Food and Drug Administration (FDA) for the treatment of some forms of adult and pediatric chronic myelogenous leukemia (CML), and for the treatment of a rare form of cancer called gastrointestinal stromal tumor (GIST).
With CML, imatinib works by blocking an abnormal enzyme characteristic of the disease. In GIST, imatinib blocks a different abnormal enzyme found on the tumor cells.
Imatinib is the first approved drug to directly turn off the signal of a protein known to cause a cancer. Other molecular-targeting drugs previously approved by the FDA interfere with proteins associated with other cancers, but not with proteins that directly cause the disease.
Imatinib is being investigated for its effectiveness against other kinds of cancer, as well, including acute lymphocytic leukemia and hypereosinophilic syndrome (HES).
Over a decade ago, Canadian patients diagnosed with chronic myeloid leukemia (CML), celebrated when PrGleevec (imatinib mesylate) was approved in Canada.
Novartis announced new data today showing a significant improvement in both recurrence-free survival and overall survival for patients taking Gleevec® (imatinib mesylate)* tablets for three years after surgery to remove KIT (CD117)-positive gastrointestinal stromal tumors (KIT+ GIST) compared to one year of treatment. These data will be presented at the 47th American Society of Clinical Oncology (ASCO) plenary session on Sunday, June 5.
Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved SUTENT® (sunitinib malate) as the first anti-VEGF therapy to treat progressive, well-differentiated pancreatic neuroendocrine tumors (NET) in patients with unresectable locally advanced or metastatic disease. Pancreatic NET is a rare cancer reported in two to four people per million annually worldwide.
Bristol-Myers Squibb Company, a leading global BioPharma company in oncology, today announced that more than 95 scientific abstracts on its approved and investigational oncology compounds will be featured at the 47th Annual Meeting of the American Society of Clinical Oncology in Chicago from June 3-7.
Pfizer Inc. announced today that the Phase 3 AXIS 1032 trial (A4061032), studying the investigational compound axitinib in previously treated patients with metastatic renal cell carcinoma (mRCC), has met its primary endpoint, demonstrating that axitinib significantly extended progression-free survival when compared to sorafenib, in the study population.
Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced the launch of My SPRYCEL (dasatinib) Support, a useful resource to assist adult patients with chronic myeloid leukemia (CML) who are taking SPRYCEL.
Pfizer Inc. announced today the discontinuation of the SUN 1120 Phase 3 trial evaluating SUTENT (sunitinib malate) in combination with prednisone for men with advanced castration-resistant prostate cancer that had progressed despite treatment with a docetaxel-based chemotherapy regimen. During a scheduled interim analysis, an independent Data Monitoring Committee found that the combination of sunitinib with prednisone was unlikely to improve overall survival when compared to prednisone alone.
Pfizer Inc. announced today that the SUN 1087 trial of sunitinib in combination with erlotinib versus erlotinib demonstrated a statistically significant improvement in Progression-Free but not in Overall Survival in patients with previously treated advanced non-small cell lung cancer (NSCLC).
Tasigna (nilotinib) capsules have been approved with conditions in Canada as a new therapy for patients with CML, in the chronic phase (first phase) of the disease. Patients must be resistant to or intolerant of at least one prior therapy, including (Pr)Gleevec (imatinib mesylate), an established standard of care.
Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced that the U.S. Food and Drug Administration has accepted for filing and review the supplemental New Drug Application for SPRYCEL (dasatinib) for the treatment of adult patients with newly diagnosed chronic myeloid leukemia in chronic phase.
Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced four-year follow-up results from a Phase 3 randomized, open-label, dose-optimization study of SPRYCEL® (dasatinib) in chronic-phase chronic myeloid leukemia (CML-CP) patients resistant or intolerant to Gleevec®* (imatinib mesylate). At four years, for all patients administered SPRYCEL 100 mg once daily, overall survival was 82% (95% CI: 76%-88%) and progression-free survival was 66% (95% CI: 57%-74%).
BioSante Pharmaceuticals, Inc. today announced the receipt of Orphan Drug designation for GVAX CML Vaccine in the treatment of chronic myeloid leukemia (CML) from the FDA's Office of Orphan Products Development. Orphan drug designation, as granted by the U.S. Orphan Drug Act, is for a product to treat a rare disease or condition that affects fewer than 200,000 people in the U.S. Orphan drug designation qualifies the sponsor of the product for tax credits and seven years of marketing exclusivity, among other benefits.
Pfizer Oncology will present new data highlighting the company's focused approach to cancer drug development through the identification and validation of molecular targets. These results will be presented at the 46th Annual American Society of Clinical Oncology meeting in Chicago from June 4-8.
New research discovers a combination of drugs that may prove to be a more effective treatment for a lethal form of leukemia. The study, published by Cell Press in the May issue of the journal Cancer Cell, reports that the new therapeutic strategy effectively targets notoriously intractable leukemia stem cells that often escape standard treatment and are a main factor in disease relapse.
Pfizer Inc. announced today the discontinuation of the SUN 1170 Phase 3 open-label study of Sutent(r) (sunitinib malate) in advanced hepatocellular carcinoma, or liver cancer. Following a review by the independent Data Monitoring Committee, the study was discontinued based on a higher incidence of serious adverse events in the sunitinib arm compared to the sorafenib arm and the fact that sunitinib did not meet the criteria to demonstrate that it was either superior or non-inferior to sorafenib in the survival of patients with advanced hepatocellular cancer.
Johns Hopkins Kimmel Cancer Center researchers say preliminary studies show that a vaccine made with leukemia cells may be able to reduce or eliminate the last remaining cancer cells in some chronic myeloid leukemia (CML) patients taking the drug Imatinib mesylate (Gleevec).
Pfizer Inc. announced today that two Phase 3 studies of Sutent® (sunitinib malate) in advanced breast cancer did not meet their primary endpoints. The SUN 1064 Phase 3 study of sunitinib in combination with docetaxel for the first-line treatment of patients with advanced HER-2 negative breast cancer did not show a statistically significant improvement in progression-free survival compared with docetaxel alone.
BioSante Pharmaceuticals, Inc. today announced positive results of a human clinical study that show that its GVAX Leukemia vaccine may be able to reduce or eliminate the last remaining cancer cells in some chronic myeloid leukemia (CML) patients taking the drug Gleevec (imatinib mesylate).
EpiCept Corporation today announced operating and financial results for the fourth quarter and year ended December 31, 2009, and provided an update on Ceplene® and several of the Company’s key product candidates.
Novartis announced today that Tasigna® (nilotinib) 200 mg capsules has been granted priority review by the US Food and Drug Administration for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase.