A5042367377- Chronic Lymphocytic Leukemia Research
- Chronic Myeloid Leukemia Treatments
- Lung Cancer Treatments and Mutations
- Multiple Myeloma Research and Treatments
- Hematopoietic Stem Cell Transplantation
- Protein Degradation and Inhibitors
- Ubiquitin and proteasome pathways
- Acute Myeloid Leukemia Research
- Computational Drug Discovery Methods
- RNA Interference and Gene Delivery
- Lymphoma Diagnosis and Treatment
- Neutropenia and Cancer Infections
- Animal testing and alternatives
- Drug Transport and Resistance Mechanisms
- Immune Cell Function and Interaction
- DNA and Nucleic Acid Chemistry
- Myeloproliferative Neoplasms: Diagnosis and Treatment
- Antibiotics Pharmacokinetics and Efficacy
- Pharmaceutical studies and practices
- Immunotoxicology and immune responses
- Eosinophilic Disorders and Syndromes
United States Food and Drug Administration
2004-2024
Center for Drug Evaluation and Research
2004-2022
Abstract Purpose: This article summarizes data submitted to the U.S. Food and Drug Administration for marketing approval of azacitidine as injectable suspension (Vidaza, Pharmion Corporation, Boulder, CO) treatment patients with myelodysplastic syndrome. Experimental Design: In one phase 3 controlled trial, 191 study subjects were randomized or observation; an additional 120 treated in two 2 single arm studies. The primary efficacy end point was overall response rate, defined complete...
Purpose: Multiple myeloma is a malignant plasma cell disorder accounting for about 10% of hematological malignancies. Despite treatment advances, including hematopoietic stem-cell transplantation to facilitate administration high-dose cytotoxic chemotherapy, the median survival remains approximately 3 years and long-term remissions are rare. Bortezomib (Velcade, formerly known as PS-341; Millennium Pharmaceuticals, Cambridge MA) dipeptide boronic acid that inhibits 20S proteasome involved in...
On November 13, 2013, the FDA granted accelerated approval to ibrutinib (IMBRUVICA capsules; Pharmacyclics, Inc.) for treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. February 12, 2014, chronic lymphocytic leukemia (CLL) Ibrutinib is a first-in-class Bruton's tyrosine kinase (BTK) inhibitor that all four expedited programs FDA: Fast-Track designation, Breakthrough Therapy Priority Review, and Accelerated Approval. Both approvals were based...
Abstract Purpose: This Food and Drug Administration (FDA) approval report describes the data analyses leading to by FDA of nilotinib (Tasigna, AMN-107; Novartis Pharmaceuticals Corporation), an inhibitor Bcr-Abl tyrosine kinase, for treatment chronic-phase (CP) accelerated-phase (AP) chronic myelogenous leukemia (CML) resistant or intolerant imatinib. Experimental Design: The efficacy safety was based on results ongoing single-arm, open-label, phase 2 clinical trial. primary end point CML-CP...
<i>Purpose:</i> On December 15, 2008, the US Food and Drug Administration approved plerixafor (Mozobil®; Genzyme Corp.), a new small-molecule inhibitor of CXCR4 chemokine receptor, for use in combination with granulocyte colony-stimulating factor (G-CSF) to mobilize hematopoietic stem cells (HSC) peripheral blood collection subsequent autologous transplantation patients non-Hodgkin’s lymphoma (NHL) multiple myeloma (MM). This summary reviews database supporting this approval....
Abstract On September 1, 2020, the FDA granted approval for oral azacitidine (Onureg, CC-486) continued treatment of adult patients with acute myeloid leukemia (AML) who achieved complete remission (CR) or incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to curative therapy. Approval was based on improvement in overall survival using CC-486 300 mg daily a 2 weeks on/2 off schedule comparison placebo (HR, 0.69; 95% confidence interval,...
Abstract On October 29, 2021, FDA granted accelerated approval to asciminib (SCEMBLIX; Novartis), a tyrosine kinase inhibitor (TKI), for the treatment of adult patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in phase (CP), previously treated two or more TKIs, and traditional Ph+ CML CP T315I mutation. The first indication was approved based on major molecular response (MMR) at 24 weeks ASCEMBL study, randomized trial comparing bosutinib who had failed TKIs....
<div>Abstract<p>On October 29, 2021, FDA granted accelerated approval to asciminib (SCEMBLIX; Novartis), a tyrosine kinase inhibitor (TKI), for the treatment of adult patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph<sup>+</sup> CML) in phase (CP), previously treated two or more TKIs, and traditional Ph<sup>+</sup> CML CP T315I mutation. The first indication was approved based on major molecular response (MMR) at 24 weeks ASCEMBL...