The U.S. Food and Drug Administration approved Novartis’ first-in-class Scemblix (asciminib) for two indications in the treatment of chronic myeloid leukemia (CML).
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 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.
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.
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.
Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration accepted its supplemental New Drug Application to include an indication for Sprycel (dasatinib) to treat children with Philadelphia chromosome-positive chronic phase chronic myeloid leukemia, as well as a powder for oral suspension formulation of Sprycel. The application is under priority review with an action date of November 9, 2017.
The U.S. Securities and Exchange Commission filed insider trading charges against two former executives and the husband of a former staffer of Ariad Pharmaceuticals.
Pfizer’s cancer drug Bosulif was found superior to Novartis’ Gleevec in a late-stage study on untreated patients with a form of blood and bone marrow cancer.