Horizon scanning: US FDA approves regorafenib for advanced gastrointestinal stromal tumors
Source: US FDA
Area: News
The U.S. Food and Drug Administration (FDA) has approved regorafenib (Stivarga) for the treatment of patients with advanced gastrointestinal stromal tumours (GIST) that cannot be surgically removed and no longer respond to other FDA-approved treatments for this disease - imatinib and sunitinib.
The approval is based on the results of the GRID trial, previously reported on the NeLM in November 2012 - please see link below details. (Source: NeLM - News)
Source: NeLM - News - February 26, 2013 Category: Drugs & Pharmacology Source Type: news
CHMP recommends approval of Imatinib Actavis
Source: European Medicines Agency
Area: News
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the granting of a marketing authorisation for Imatinib Actavis for the treatment of:
. Paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment.
. Paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis.
...
Source: NeLM - News - February 25, 2013 Category: Drugs & Pharmacology Source Type: news
RCT: Imatinib mesylate as add-on therapy for pulmonary arterial hypertension: (IMPRES)
Source: Circulation
Area: News
A recent phase II study has reported that imatinib could improve pulmonary haemodynamics, especially in those with greater haemodynamic impairment. The aim of the present international RCT (IMPRES) was to evaluate the safety, tolerability and efficacy of imatinib in patients with advanced pulmonary arterial hypertension (PAH).
Patients with pulmonary vascular resistance (PVR) ?800 dynes/sec/cm5 who were symptomatic on more than 2 PAH therapies (41% patients received 3 PAH therapies with the remainder on 2 therapies) were randomised to imatinib (n=103; starting dose of 200mg) or pl...
Source: NeLM - Cardiovascular Medicine - February 13, 2013 Category: Cardiology Source Type: news
Glimmer of hope for imatinib-resistant GIST
The monoclonal antibody SR1 can significantly inhibit gastrointestinal stromal tumor cell growth, report researchers in the Proceedings of the National Academy of Sciences. (Source: MedWire News - Gastroenterology)
Source: MedWire News - Gastroenterology - February 8, 2013 Category: Gastroenterology Source Type: news
Glimmer of hope for imatinib-resistant GIST
The monoclonal antibody SR1 can significantly inhibit gastrointestinal stromal tumor cell growth, report researchers in the Proceedings of the National Academy of Sciences. (Source: MedWire News - Oncology)
Source: MedWire News - Oncology - February 8, 2013 Category: Cancer & Oncology Source Type: news
Growth Of Gleevec-Resistant Gastrointestinal Tumors Hindered By Antibody In Lab Tests
An antibody that binds to a molecule on the surface of a rare but deadly tumor of the gastrointestinal tract inhibits the growth of the cancer cells in mice, according to researchers at the Stanford University School of Medicine. The effect remains even when the cancer cells have become resistant to other treatments, and the findings may one day provide a glimmer of hope for people with the cancer, known as gastrointestinal stromal tumor, or GIST. The scientists hope to move into human clinical trials of the antibody within two years... (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - February 6, 2013 Category: Consumer Health News Tags: GastroIntestinal / Gastroenterology Source Type: news
ASCO GI: Improved GIST Survival With Residual Tumor Removal Post-Maintenance Imatinib
Assigning patients with gastrointestinal stromal tumor (GIST) to undergo surgical resection of residual tumor after disease control with maintenance imatinib was beneficial to patient survival, according to the results of a retrospective study presented at the ASCO 2013 Gastrointestinal Cancers Symposium. (Source: Cancer Network)
Source: Cancer Network - February 1, 2013 Category: Cancer & Oncology Source Type: news
FDA Approves Imatinib (Gleevec) for Pediatric ALL
The US Food and Drug Administration has approved imatinib (Gleevec) for the treatment of newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia (Ph+ ALL) in children. (Source: Cancer Network)
Source: Cancer Network - January 30, 2013 Category: Cancer & Oncology Source Type: news
US Approves Imatinib for Children With Ph+ Acute Lymphoblastic Leukemia
Imatinib has been approved to treat children newly diagnosed with Philadelphia chromosome-positive acute lymphoblastic leukemia, the U.S. Food and Drug Administration announced Jan. 25.Imatinib, a tyrosine... (Source: OncologySTAT Latest News)
Source: OncologySTAT Latest News - January 29, 2013 Category: Cancer & Oncology Source Type: news
FDA approves imatinib for children with acute lymphoblastic leukemia
Source: FDA
Area: News
The FDA has approved imatinib for the treatment of newly diagnosed Philadelphia positive (Ph+) acute lymphoblastic leukaemia (ALL) in children.
The clinical data to support this indication come from a study which enrolled ninety-two children aged 1 year and over with very high risk ALL. Patients were divided in to five treatment groups with each successive group receiving a greater duration of imatinib therapy in combination with chemotherapy. Fifty Ph+ ALL patients received imatinib for the longest duration and 70% of these had an event free survival of four years, Results also showed t...
Source: NeLM - News - January 28, 2013 Category: Drugs & Pharmacology Source Type: news
FDA Approves Gleevec for Children with Acute Lymphoblastic Leukemia
January 25, 2013 -- The U.S. Food and Drug Administration today approved a new use of Gleevec (imatinib) to treat children newly diagnosed with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL).
ALL is the most common type... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 26, 2013 Category: Drugs & Pharmacology Source Type: news
FDA Gives Nod to Gleevec for Pediatric ALL
(MedPage Today) -- SILVER SPRING, Md. -- Imatinib (Gleevec) may be used to treat children with newly diagnosed, Philadelphia chromosome-positive acute lymphoblastic leukemia, the FDA said Friday. (Source: MedPage Today Hematology/Oncology)
Source: MedPage Today Hematology/Oncology - January 25, 2013 Category: Hematology Source Type: news
FDA Approves Imatinib for Pediatric ALLFDA Approves Imatinib for Pediatric ALL
This is the second pediatric cancer indication for the therapy. FDA Approvals (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - January 25, 2013 Category: Consumer Health News Tags: Hematology-Oncology News Alert Source Type: news
Resecting Residual Gastrointestinal Stromal Tumors Improved Survival
SAN FRANCISCO (IMNG) - Surgically removing residual gastrointestinal stromal tumors in patients who respond to imatinib therapy significantly increased time to tumor progression to 88 months, compared... (Source: OncologySTAT Latest News)
Source: OncologySTAT Latest News - January 25, 2013 Category: Cancer & Oncology Source Type: news
FDA Approves New Use for Cancer Drug
The U.S. FDA approved a new use for Novartis AG's cancer drug, Gleevec, in children. (Source: WSJ.com: Health)
Source: WSJ.com: Health - January 25, 2013 Category: Pharmaceuticals Tags: PAID Source Type: news
