Methotrexate is an antimetabolite and antifolate agent with antineoplastic and immunosuppressant activities. Methotrexate binds to and inhibits the enzyme dihydrofolate reductase, resulting in inhibition of purine nucleotide and thymidylate synthesis and, subsequently, inhibition of DNA and RNA syntheses. Methotrexate also exhibits potent immunosuppressant activity although the mechanism(s) of actions is unclear.
Methotrexate is approved by the Food and Drug Administration (FDA) to be used by itself to treat the following types of gestational trophoblastic tumors, Chorioadenoma destruens, Choriocarcinoma, Hydatidiform mole. Methotrexate is also approved to be used alone or with other drugs to treat acute lymphoblastic leukemia (ALL) that has spread to the central nervous system (CNS) or to keep it from spreading there, and to treat the following, breast cancer, certain types of head and neck cancer, lung cancer, advanced non-Hodgkin lymphoma (NHL), advanced mycosis fungoides (a type of cutaneous T-cell lymphoma), osteosarcoma that has not spread to other parts of the body, following surgery to remove the primary tumor. Methotrexate is also approved to treat the following non-cancer conditions, rheumatoid arthritis, severe psoriasis.
Genentech, Inc., a member of the Roche Group, today announced that the United States Food and Drug Administration has extended the ACTEMRA (tocilizumab, RoACTEMRA in the European Union) label to include inhibition and slowing of structural joint damage, improvement of physical function, and achievement of major clinical response in adult patients with moderately to severely active rheumatoid arthritis, when given in combination with methotrexate.
Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, today announced it submitted a supplemental New Drug Application with the U.S. Food and Drug Administration (FDA) for a Ready-to-Use formulation of FUSILEV (levoleucovorin) for Injection.
Patients with early rheumatoid arthritis (RA) who are current smokers were less likely to achieve good response to methotrexate (MTX) and tumor necrosis factor (TNF) inhibitors than those who never smoked. The study by researchers from Sweden also found that RA patients who smoked in the past did not experience a lower response to these therapies. Results of the 10-year study appear in the January 2011 issue of Arthritis & Rheumatism, a journal published by Wiley-Blackwell on behalf of the American College of Rheumatology (ACR).
Centocor Ortho Biotech Inc. announced today that it has filed a supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) requesting the approval of REMICADE® (infliximab) for the treatment of moderately to severely active ulcerative colitis (UC) in pediatric patients who have had an inadequate response to conventional therapy.
Research led by St. Jude Children-s Research Hospital investigators will likely impact how acute lymphoblastic leukemia is treated in young adults and shows older adolescent age does not dictate worse outcomes against the most common childhood cancer.
Chelsea Therapeutics International, Ltd. announced it has completed a pre-NDA assessment with the U.S. Food and Drug Administration (FDA) and intends to accelerate its new drug application (NDA) for NORTHERA™(droxidopa) for the treatment of symptomatic, neurogenic orthostatic hypotension (NOH), a chronic and potentially debilitating drop in blood pressure upon standing commonly associated Parkinson's disease, multiple system atrophy and pure autonomic failure.
4SC AG, a drug discovery and development company focused on autoimmune and cancer indications, today reported that it has completed enrolment of its COMPONENT Phase IIb study with vidofludimus, an oral inhibitor of IL-17 release, in rheumatoid arthritis (RA) patients. Data from the trial are expected to be announced in Q2 2011.
Many patients seen at a rheumatology clinic—including some with a long history of rheumatoid arthritis (RA)—don't recognize important terms related to their health and medical treatment, reports a study in the December issue of JCR: Journal of Clinical Rheumatology.
Lexicon Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering breakthrough treatments for human disease, announced top-line results from a recently completed Phase 2a study of LX2931 in patients with rheumatoid arthritis (RA). LX2931 is an orally-delivered, small molecule drug candidate that inhibits sphingosine-1-phosphate (S1P) lyase, an enzyme important for modulating the immune system by controlling S1P levels in lymphoid tissues.
Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for the subcutaneous formulation of ORENCIA® (abatacept), a treatment for adult patients with moderate to severe rheumatoid arthritis (RA) administered through an injection into the skin. Bristol-Myers Squibb submitted the sBLA to the FDA for the subcutaneous formulation of ORENCIA and received confirmation of its receipt on October 4, 2010.
Genentech, Inc., a member of the Roche Group, and Biogen Idec announced today positive data from a Phase III study of Rituxan (rituximab) in patients with advanced follicular lymphoma who did not have symptoms of disease (asymptomatic disease).
Allos Therapeutics, Inc. today reported updated results from the Company's Phase 1 dose-finding study of FOLOTYN® (pralatrexate injection) which supports the selection of 15 mg/m2 weekly for three weeks out of a four-week cycle as the optimal starting dose and schedule for further evaluation in patients with relapsed or refractory cutaneous T-cell lymphoma. Data were presented at the 52nd American Society of Hematology Annual Meeting in Orlando, Florida.
Magnetic resonance imaging (MRI) analyses from two Phase 3 clinical trials showed that once every four week subcutaneous injections of golimumab 50 mg plus methotrexate resulted in statistically significant improvements in markers of inflammation and structural damage in patients with active rheumatoid arthritis (RA) compared with placebo plus methotrexate.
Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the complete response regarding its supplemental New Drug Application (sNDA) for FUSILEV® (levoleucovorin) for Injection for treatment of patients with advanced metastatic colorectal cancer.
Incyte Corporation announced the presentation of final six-month clinical data from the dose ranging, placebo-controlled Phase IIa trial of its orally available janus kinase (JAK) inhibitor INCB28050 in patients with active rheumatoid arthritis (RA).
Today, Abbott presents results from a pooled analysis of two pivotal HUMIRA® (adalimumab) studies, which look at patients with early and long-standing moderate to severe rheumatoid arthritis (RA), at the American College of Rheumatology meeting in Atlanta.
People with rheumatic diseases don't take their medication on a regular basis, and this leads to poor outcomes in their disease treatment, according to research presented this week at the American College of Rheumatology Annual Scientific Meeting in Atlanta.
Children with juvenile idiopathic arthritis have a two to threefold increased risk of developing cancer compared to similarly-aged children without JIA, according to research presented this week at the American College of Rheumatology Annual Scientific Meeting in Atlanta. The same study also reported no cases of cancer in children with JIA who were exposed to anti-TNF therapy.
Pfizer Inc. today announced results of ORAL Solo (1045), a Phase 3 study that showed tasocitinib (CP-690,550), an investigational, novel, oral JAK inhibitor, administered as monotherapy met two primary endpoints, demonstrating a statistically significant reduction in signs and symptoms of moderately to severely active rheumatoid arthritis (RA) and improvement in physical function as measured by ACR20 response rates and mean change in HAQ-DI, respectively, versus placebo at three months.
People with newly-developed rheumatoid arthritis or undifferentiated arthritis may be able to achieve remission, with continued drug therapy, after four months of treatment with methotrexate and prednisone, according to research presented this week at the American College of Rheumatology Annual Scientific Meeting in Atlanta.
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