On November 23, 2020 Taiho Oncology, Inc. reported that the FDA approved hypomethylating agent INQOVI (decitabine and cedazuridine) 35 mg/100 mg tablets, for oral use, has been included in the latest National Comprehensive Cancer Network Clinical Practice Guidelines (NCCN Guidelines) in Oncology for Myelodysplastic Syndromes (MDS) (Press release, Taiho, NOV 23, 2020, View Source [SID1234571612]). The NCCN Guidelines now include a category 2a recommendation that oral decitabine and cedazuridine (DEC-C) could be considered as a substitution for intravenous decitabine in the treatment of adult patients with MDS.1
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Specifically, the treatment guidelines allow the substitution of INQOVI for intravenous decitabine in appropriate patients with MDS who are experiencing clinically significant cytopenias or increased marrow blasts, significant anemia or are transplant candidates. The U.S. Food and Drug Administration (FDA) approved INQOVI on July 7, 2020 as the first oral hypomethylating agent for intermediate and high-risk MDS. In September, NCCN, an alliance of 30 leading cancer centers in the U.S., updated the NCCN Guidelines for Myelodysplastic Syndromes.
"The addition of INQOVI to the Clinical Practice Guidelines in Oncology for Myelodysplastic Syndromes will further inform healthcare providers of a new oral treatment option," said Karin Blakolmer, Senior Vice President and Head of Medical Affairs, Taiho Oncology, Inc. "As the first orally administered hypomethylating agent for MDS, and an important alternative to multiple monthly intravenous infusions, Taiho Oncology believes that INQOVI will help address unmet treatment needs for patients who may currently have limited access to in-office intravenous therapy. We look forward to working with healthcare professionals to bring this therapy to appropriate patients."
Taiho Oncology previously announced it has assumed commercialization responsibility from Astex Pharmaceuticals, Inc. and its parent company, Otsuka Pharmaceutical Co., Ltd., for INQOVI in the U.S.
The updated NCCN Guidelines are available at www.nccn.org.
About Myelodysplastic Syndromes (MDS)
Myelodysplastic syndromes are a heterogeneous group of hematopoietic stem cell disorders characterized by dysplastic changes in myeloid, erythroid, and megakaryocytic progenitor cells, and are associated with cytopenias affecting one or more of the three lineages. U.S. incidence of MDS is estimated to be 10,000 cases per year, although the condition is thought to be under-diagnosed.2,3 The prevalence has been estimated to be from 60,000 to 170,000 in the U.S.4 MDS may evolve into acute myeloid leukemia (AML) in approximately one-third of patients.5 The prognosis for MDS patients is poor; patients die from complications associated with cytopenias (infections and bleeding) or from transformation to AML.