INQOVI (See https://www.inqovi.com)

Astex Pharmaceuticals and MD Anderson Announce Strategic Collaboration to Accelerate Clinical Evaluation of Therapies for Patients with Leukemia

Retrieved on: 
Tuesday, September 8, 2020
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Health, Astex, Otsuka Pharmaceutical, Clinical trial, University of Texas MD Anderson Cancer Center, INQOVI (See https://www.inqovi.com), MD Anderson, Astex Pharmaceuticals, Otsuka Pharmaceutical and Taiho Oncology

The collaboration will combine MD Andersons clinical trials infrastructure and expertise with Astexs clinical pipeline products.

Key Points: 
  • The collaboration will combine MD Andersons clinical trials infrastructure and expertise with Astexs clinical pipeline products.
  • This collaboration with Astex will allow us to expand those studies with the ultimate goal of providing patients with oral drug combinations that have the potential of improving clinical outcomes.
  • Under the collaboration agreement, MD Anderson and Astex will design new clinical studies to be conducted at MD Anderson.
  • MD Anderson has been a collaborator with Astex on multiple clinical studies for our pipeline products, said Mohammad Azab, president & chief medical officer of Astex.

Astex Pharmaceuticals, Taiho Oncology, and Otsuka Pharmaceutical Announce FDA and Health Canada Approval of INQOVI® (Decitabine and Cedazuridine) Tablets, Oral Hypomethylating Agent (HMA) Therapy for Intermediate and High-Risk MDS and CMML

Retrieved on: 
Wednesday, July 8, 2020
Oncology, Health, FDA, Clinical trials, Pharmaceutical, Biotechnology, Nucleosides, Chemical compounds, Organic compounds, Decitabine, Janssen Pharmaceutica, Lactams, Triazines, Myelodysplastic syndrome, Hypomethylating agent, Chronic myelomonocytic leukemia, Astex, Clinical medicine, INQOVI (See https://www.inqovi.com), Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML), Astex, Taiho, and Otsuka

Astex Pharmaceuticals, Inc.; Taiho Oncology, Inc.; and Otsuka Pharmaceutical Co., Ltd. today announce that the U.S. Food and Drug Administration (FDA) and Health Canada have approved INQOVI (decitabine and cedazuridine) tablets.

Key Points: 
  • Astex Pharmaceuticals, Inc.; Taiho Oncology, Inc.; and Otsuka Pharmaceutical Co., Ltd. today announce that the U.S. Food and Drug Administration (FDA) and Health Canada have approved INQOVI (decitabine and cedazuridine) tablets.
  • INQOVI is the first and only orally administered hypomethylating agent for the treatment for adults with intermediate and high-risk myelodysplastic syndromes (MDS) including chronic myelomonocytic leukemia (CMML),1 two blood malignancies.
  • Approval was based on data from the ASCERTAIN phase 3 study and supporting phase 1 and 2 clinical studies.
  • The ASCERTAIN phase 3 study evaluated the five-day, decitabine exposure equivalence between oral INQOVI and intravenous decitabine.