The U.S. Food and Drug Administration and Health Canada approved Inqovi (decitabine and cedazuridine) tablets as the first orally administered hypomethylating agent for the treatment for adults with intermediate and high-risk myelodysplastic syndromes (MDS).
Helsinn Group, based in Lugano, Switzerland, and MEI Pharma, with headquarters in San Diego, announced they were discontinuing their Phase III trial of pracinostat with azacytidine in acute myeloid leukemia (AML).
The American Society of Clinical Oncology (ASCO) 2020 meeting was held virtually this year due to the COVID-19 pandemic and included hundreds of abstracts, posters and presentations.
The U.S. Food and Drug Administration approved Clovis Oncology Inc.’s Rubraca (rucaparib) tablets for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy.
The U.S. Food and Drug Administration approved Bristol Myers Squibb Co. and Acceleron Pharma Inc.’s Reblozyl (luspatercept-aamt) for the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis.
Gilead Sciences Inc. is buying Forty Seven Inc. for $95.50 per share, or a deal value of $4.9 billion. The deal was unanimously approved by both companies’ boards.
Astex Pharmaceuticals Inc. announced that the U.S. FDA accepted for Priority Review the company’s NDA for oral C-DEC (cedazuridine and decitabine) as a treatment for adults with previously untreated intermediate- and high-risk myelodysplastic syndromes, including chronic myelomonocytic leukemia.
Hundreds of studies and results were presented at the 61st American Society of Hematology (ASH) Annual Meeting.
Astex Pharmaceuticals and Otsuka Pharmaceutical announced that the companies’ ASCERTAIN Phase III clinical trial of cedazuridine and decitabine (ASTX727) compared to decitabine IV alone hit the study’s primary endpoints.
Celgene and developmental partner Acceleron Pharma are eying a potential U.S. FDA approval of a blood-disease treatment.