Free clinical trials for acute myeloid leukemia

FREE CLINICAL TRIALS FOR ACUTE MYELOID LEUKEMIA TRIAL
FREE CLINICAL TRIALS FOR ACUTE MYELOID LEUKEMIA PLUS

The most common adverse reactions (в‰Ґ10%) in newly diagnosed AML patients receiving TIBSOVO in combination with azacitidine were nausea, vomiting, electrocardiogram QT prolonged, insomnia, differentiation syndrome, leukocytosis, hematoma, hypertension, arthralgia, dyspnea, and headache.

FREE CLINICAL TRIALS FOR ACUTE MYELOID LEUKEMIA PLUS

The combination of TIBSOVO plus azacitidine demonstrated a safety profile consistent with previously published data. 'Today's approval of TIBSOVO in combination with azacitidine represents a major advancement for patients with newly diagnosed IDH1-mutated acute myeloid leukemia in the United States, and we look forward to continuing our engagement with regulatory authorities worldwide.' 'People living with acute myeloid leukemia, especially those who are newly diagnosed and are not eligible for intensive chemotherapy, have had few treatment options,' said Susan Pandya, M.D., Vice President Clinical Development and Head of Cancer Metabolism Global Development Oncology & Immuno-Oncology, Servier. 3,4 IDH1 mutations are present in about 6 to 10 percent of AML cases. 'In addition to a favorable safety profile, TIBSOVO is the first therapy targeting cancer metabolism to demonstrate an impressive, significant benefit in event-free survival and overall survival in combination with azacitidine, underscoring its importance as part of a new combination regimen for patients with newly diagnosed IDH1-mutated acute myeloid leukemia who are not candidates for intensive induction chemotherapy.'ДЄML is a difficult-to-treat cancer of the blood and bone marrow and is one of the most common types of leukemia in adults with approximately 20,000 new cases estimated in the U.S. Stein, M.D., Director, Program for Drug Development in Leukemia, Leukemia Service, Department of Medicine at Memorial Sloan Kettering Cancer Center.

'Acute myeloid leukemia is a rapidly progressing, difficult-to-treat blood cancer with a poor prognosis,' said Eytan M. Results from the AGILE study were presented at the 2021 American Society of Hematology (ASH) Annual Meeting and Exposition, and recently published in the New England Journal of Medicine (NEJM). TIBSOVO plus azacitidine treatment resulted in a threefold improvement in median OS (24 months) compared to placebo plus azacitidine (7.9 months) as a first-line treatment for IDH1-mutated AML.

FREE CLINICAL TRIALS FOR ACUTE MYELOID LEUKEMIA TRIAL

Results from the AGILE trial demonstrated a statistically significant improvement in event-free survival (EFS) (hazard ratio = 0.35, 2-sided p-value = 0.0038) 2 and overall survival (OS) (HR = 0.44 2-sided p = 0.0010). The expanded approval of TIBSOVO is supported by data from the AGILE study, a global, Phase 3 trial in patients with previously untreated IDH1-mutated AML. 'As a leader in oncology pioneering the science behind targeted IDH inhibition, we are proud to bring a new therapeutic option to the acute myeloid leukemia community and remain committed to pushing the boundaries of healthcare innovation in oncology and beyond.' Lee, Chief Executive Officer, Servier Pharmaceuticals. 'Today's approval builds on the established body of evidence for TIBSOVO, which is now approved across multiple IDH1-mutated cancer types,' said David K.

The supplemental New Drug Application (sNDA) for TIBSOVO received Priority Review and was reviewed by the FDA under its Real-Time Oncology Review (RTOR) pilot program, which aims to ensure that safe and effective treatments are available to patients as early as possible. The AGILE trial was the only Phase 3 trial designed specifically for newly diagnosed patients with IDH1-mutated AML who are ineligible for intensive chemotherapy. TIBSOVO is the first therapy targeting cancer metabolism approved in combination with azacitidine for patients with newly diagnosed IDH1-mutated AML. Food and Drug Administration (FDA) approved TIBSOVO В® (ivosidenib tablets) in combination with azacitidine for the treatment of patients with newly diagnosed IDH1-mutated acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. FDA approval based on data from the global, Phase 3 AGILE trial that demonstrated a statistically significant improvement in event-free survival and overall survivalД«OSTON, /PRNewswire/ - Servier, a leader in oncology committed to bringing the promise of tomorrow to the patients we serve, today announced that the U.S.

Free clinical trials for acute myeloid leukemia