The U.S. Food and Drug Administration approved Takeda Pharmaceutical’s supplemental New Drug Application for Iclusig (ponatinib) for adult patients with chronic-phase chronic myeloid leukemia with resistance or intolerance to at least two prior kinase inhibitors.
Novartis drug candidate asciminib notched a trial win against Pfizer’s Bosulif as the Swiss drugmaker pushes to expand medicines for chronic myeloid leukemia in patients for whom other treatments stopped working.
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).
The U.S. FDA declined to approve Daiichi Sankyo Co.’s drug quizartinib as a treatment for adults with a type of blood cancer.
The European Commission approved Sprycel (dasatinib) to include the treatment of children and adolescents aged 1 year to 18 years with Philadelphia chromosome-positive CML in chronic phase.
Amgen Inc. and The University of Texas MD Anderson Cancer Center announced two multi-year collaborative research deals for a broad range of cancer therapeutics. The cancers studied will include leukemia, myelodysplastic syndromes (MDS), multiple myeloma, small-cell lung cancer, and other non-lung cancers with small-cell histologies.
Novartis announced that the U.S. Food and Drug Administration expanded the indication for Tasigna (nilotinib) to include treatment of first- and second-line pediatric patients one year of age or older with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase.
Britain’s healthcare watchdog NICE recommended Roche’s medicine Gazyvaro for previously untreated advanced follicular lymphoma patients after initially rejecting the medicine in 2017.
Novartis announced that the FDA approved the inclusion of Treatment-free Remission data in the Tasigna (nilotinib) U. S. product label.
The biopharma industry and the U.S. Food and Drug Administration face a busy December with nine companies awaiting approval decisions.